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MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb

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ClinicalTrials.gov Identifier: NCT04649359
Recruitment Status : Active, not recruiting
First Posted : December 2, 2020
Results First Posted : October 25, 2023
Last Update Posted : April 30, 2024
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Intervention Drug: Elranatamab (PF-06863135)
Enrollment 188
Recruitment Details Participants with relapsed/refractory multiple myeloma (RRMM), who were refractory to at least 1 proteasome inhibitor, 1 immunomodulatory drug, and 1 anti-cluster of differentiation38 (CD38) monoclonal antibody were included. Study enrolled participants into 2 independent and parallel cohorts: cohort A and B.
Pre-assignment Details A total of 187 participants were enrolled and assigned to study treatment. Results are reported at primary completion date. Data for only those primary and secondary outcome measures whose analysis is complete and final have been reported. Data for remaining secondary outcome measures will be posted upon completion of analysis at secondary completion date.
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description Participants who had not previously received a B-cell maturation antigen (BCMA)-directed therapy (BCMA-naïve participants) received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8. Each cycle was 28 days. Treatment was continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. If a participant had received weekly dosing (QW) for at least 6 cycles and had achieved a partial response (PR) or better persisting for at least 2 months, the dose interval was changed to once every 2 weeks (Q2W). The initial 4 enrolled participants received subcutaneous elranatamab with a priming regimen of 44 mg on Cycle 1 Day 1 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8. Participants who had previously received a BCMA-directed therapy (BCMA-exposed) received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8. Each cycle was 28 days. Treatment was continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination. If a participant had received weekly dosing (QW) for at least 6 cycles and had achieved a partial response (PR) or better persisting for at least 2 months, the dose interval was changed to once every 2 weeks (Q2W).
Period Title: Overall Study
Started 123 64
Completed 0 0
Not Completed 123 64
Reason Not Completed
Withdrawal by Subject             7             7
Death             41             26
Ongoing in the study             75             31
Arm/Group Title Cohort A Cohort B Total
Hide Arm/Group Description BCMA-naïve participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8. BCMA-exposed participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8. Total of all reporting groups
Overall Number of Baseline Participants 123 64 187
Hide Baseline Analysis Population Description
Safety analysis set in each cohort included all enrolled participants in the respective cohort who received at least one dose of study intervention.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 123 participants 64 participants 187 participants
67.1  (9.45) 65.7  (9.42) 66.6  (9.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 64 participants 187 participants
Female
55
  44.7%
34
  53.1%
89
  47.6%
Male
68
  55.3%
30
  46.9%
98
  52.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 64 participants 187 participants
Hispanic or Latino
11
   8.9%
7
  10.9%
18
   9.6%
Not Hispanic or Latino
85
  69.1%
34
  53.1%
119
  63.6%
Unknown or Not Reported
27
  22.0%
23
  35.9%
50
  26.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 64 participants 187 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
16
  13.0%
1
   1.6%
17
   9.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
   7.3%
2
   3.1%
11
   5.9%
White
72
  58.5%
44
  68.8%
116
  62.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
26
  21.1%
17
  26.6%
43
  23.0%
1.Primary Outcome
Title Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) as Per International Myeloma Working Group (IMWG) Criteria
Hide Description ORR: % of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. sCR: CR & normal serum free light chain (sFLC) ratio & absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytoma & <5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio. VGPR: Serum & urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum M-protein & urine M-protein level <100mg/24h. PR: >=50% reduction in serum M-protein & reduction in 24h urinary M-protein by >=90% or <200 mg/24h. If serum & urine M-protein were unmeasurable, VGPR & PR: >=90% & >=50% decrease in difference respectively between involved & uninvolved sFLC levels & if present at baseline, >=90% & >=50% reduction in soft tissue plasmacytomas' size.
Time Frame From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set in each cohort included all enrolled participants in the respective cohort who received at least one dose of study intervention.
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description:
BCMA-naïve participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
BCMA-exposed participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Overall Number of Participants Analyzed 123 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
61.0
(51.8 to 69.6)
34.4
(22.9 to 47.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A
Comments Null hypothesis of ORR by BICR for cohort A was 30%.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Exact binominal
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort B
Comments Null hypothesis of ORR by BICR for cohort B was 15%.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Exact binominal
Comments [Not Specified]
2.Secondary Outcome
Title Cohort A Only: Objective Response Rate as Per IMWG Criteria by BICR for Participants With Extramedullary Disease (EMD) at Baseline
Hide Description ORR: % of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. sCR: CR & normal serum free light chain (sFLC) ratio & absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytoma & <5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio. VGPR: Serum & urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum M-protein & urine M-protein level <100mg/24h. PR: >=50% reduction in serum M-protein & reduction in 24h urinary M-protein by >=90% or <200 mg/24h. If serum & urine M-protein were unmeasurable, VGPR & PR: >=90% & >=50% decrease in difference respectively between involved & uninvolved sFLC levels & if present at baseline, >=90% & >=50% reduction in soft tissue plasmacytomas' size.
Time Frame From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all enrolled participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies number of participants with EMD at baseline. This outcome measure was planned only in Cohort A.
Arm/Group Title Cohort A
Hide Arm/Group Description:
BCMA-naïve participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Overall Number of Participants Analyzed 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
38.5
(23.4 to 55.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A
Comments Null hypothesis of ORR by BICR for cohort A was 12%.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Exact binominal
Comments [Not Specified]
3.Secondary Outcome
Title Cohort A Only: Objective Response Rate as Per IMWG Criteria by BICR for Participants Without EMD at Baseline
Hide Description ORR: % of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. sCR: CR & normal serum free light chain (sFLC) ratio & absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytoma & <5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio. VGPR: Serum & urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum M-protein & urine M-protein level <100mg/24h. PR: >=50% reduction in serum M-protein & reduction in 24h urinary M-protein by >=90% or <200 mg/24h. If serum & urine M-protein were unmeasurable, VGPR & PR: >=90% & >=50% decrease in difference respectively between involved & uninvolved sFLC levels & if present at baseline, >=90% & >=50% reduction in soft tissue plasmacytomas' size.
Time Frame From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all enrolled participants who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies number of participants without EMD at baseline. This outcome measure was planned only in Cohort A.
Arm/Group Title Cohort A
Hide Arm/Group Description:
BCMA-naïve participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Overall Number of Participants Analyzed 84
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
71.4
(60.5 to 80.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A
Comments Null hypothesis of ORR by BICR for cohort A was 38%.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Exact binominal
Comments [Not Specified]
4.Secondary Outcome
Title Duration of Response (DOR) as Per IMWG Criteria by BICR
Hide Description DOR: time from first documentation of objective response subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.
Time Frame From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months)
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Duration of Response as Per IMWG Criteria by Investigator Assessment
Hide Description DOR: time from first documentation of objective response subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.
Time Frame From first documentation of objective response subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months)
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Complete Response Rate (CRR) as Per IMWG Criteria by BICR
Hide Description CRR: % of participants with BOR of confirmed sCR/CR per IMWG criteria. sCR: CR & normal serum free light chain (sFLC) ratio & absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytoma & <5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio.
Time Frame From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months)
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Complete Response Rate as Per IMWG Criteria by Investigator Assessment
Hide Description CRR: % of participants with BOR of confirmed sCR/CR per IMWG criteria. sCR: CR & normal serum free light chain (sFLC) ratio & absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytoma & <5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio.
Time Frame From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months)
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Objective Response Rate as Per IMWG Criteria by Investigator Assessment
Hide Description ORR: % of participants with best overall response of confirmed stringent complete response (sCR), CR, very good partial response (VGPR) or PR per IMWG criteria. sCR: CR & normal serum free light chain (sFLC) ratio & absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytoma & <5% plasma cells in BMA, if disease measurable by sFLC only, preceding criteria plus normal sFLC ratio. VGPR: Serum & urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum M-protein & urine M-protein level <100mg/24h. PR: >=50% reduction in serum M-protein & reduction in 24h urinary M-protein by >=90% or <200 mg/24h. If serum & urine M-protein were unmeasurable, VGPR & PR: >=90% & >=50% decrease in difference respectively between involved & uninvolved sFLC levels & if present at baseline, >=90% & >=50% reduction in soft tissue plasmacytomas' size.
Time Frame From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months)
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Duration of Complete Response (DOCR) as Per IMWG Criteria by BICR
Hide Description DOCR: time from first documentation of sCR/CR subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.
Time Frame From first documentation of sCR/CR subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months)
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Duration of Complete Response (DOCR) as Per IMWG Criteria by Investigator Assessment
Hide Description DOCR: time from first documentation of sCR/CR subsequently confirmed, until first documentation of confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.
Time Frame From first documentation of objective sCR/CR subsequently confirmed until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months)
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Progression Free Survival (PFS) as Per IMWG Criteria by BICR
Hide Description PFS was defined as the time from the date of first dose until confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.
Time Frame From date of first dose until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months)
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Progression Free Survival (PFS) as Per IMWG Criteria by Investigator Assessment
Hide Description PFS was defined as the time from the date of first dose until confirmed PD or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; urine M-protein [absolute increase >=200mg/24h]; participants without measurable serum & urine M-protein levels, difference between involved & uninvolved sFLC levels [absolute increase >10mg/dL]; in participants without measurable serum, urine M-protein levels & involved sFLC levels: bone marrow plasma-cell % irrespective of baseline status [absolute increase >=10%]; appearance of new lesion,>=50% increase from nadir in SPD of >1 lesion, or >=50% increase in longest diameter of previous lesion >1cm in short axis; >=50% increase in circulating plasma cells [>=200cells/μL] if this is the only measure of disease.
Time Frame From date of first dose until confirmed PD or death due to any cause, or start of new anticancer therapy, whichever occurred first, or censoring (up to approximately 20.14 months)
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival (OS) was defined as the time from the date of first dose until death due to any cause.
Time Frame From the date of first dose until death due to any cause. Participants not known to have died were censored on the date of last known alive (up to approximately 20.14 months)
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Time-to-Response (TTR) as Per IMWG Criteria by BICR
Hide Description TTR was defined, for participants with an objective response per IMWG criteria, as the time from the date of first dose to the first documentation of objective response that was subsequently confirmed.
Time Frame From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 16 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set in each cohort included all enrolled participants in the respective cohort who received at least one dose of study intervention. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description:
BCMA-naïve participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
BCMA-exposed participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Overall Number of Participants Analyzed 75 22
Median (Full Range)
Unit of Measure: Months
1.22
(0.89 to 7.36)
1.92
(0.92 to 6.74)
15.Secondary Outcome
Title Time-to-Response (TTR) as Per IMWG Criteria by Investigator Assessment
Hide Description TTR was defined, for participants with an objective response per IMWG criteria, as the time from the date of first dose to the first documentation of objective response that was subsequently confirmed.
Time Frame From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months)
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Minimal Residual Disease (MRD) Negativity Rate Per IMWG Sequencing Criteria
Hide Description MRD negativity rate was the percentage of participants with CR/sCR and with negative MRD per IMWG sequencing criteria.
Time Frame From date of first dose until confirmed disease progression, death, start of new anticancer therapy, whichever occurred first (up to approximately 20.14 months)
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAE) Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered treatment-emergent relative to study intervention if the adverse event start date was during the on-treatment period (i.e. the time from the first dose of study intervention through the minimum of 90 days after last dose, or [start day of new anticancer therapy - 1 day]). CTCAE version 5.0 Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening; Grade 5: death.
Time Frame From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Number of Participants With Shift From Grade Less Than or Equal to (<=) 2 at Baseline to Grade 3 or 4 Post -Baseline in Laboratory Parameters by NCI CTCAE v 5.0
Hide Description CTCAE version 5.0 Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.
Time Frame From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Outcome Measure Data Not Reported
19.Secondary Outcome
Title Number of Participants With Cytokine Release Syndrome (CRS) Graded According to American Society for Transplantation and Cellular Therapy (ASTCT) Criteria
Hide Description CRS Grade 1: temperature >=38°C without hypotension or hypoxia; Grade 2: temperature >=38°C with hypotension not requiring vasopressors, and/or hypoxia requiring low-flow nasal cannula, facemask or blow-by; Grade 3: temperature >=38°C with hypotension requiring a vasopressor with or without vasopressin and/or hypoxia requiring high-flow nasal cannula, facemask, nonrebreather mask, or Venturi mask; Grade 4: temperature >=38°C with hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring positive pressure (eg, continuous positive airway pressure [CPAP], bilevel positive airway pressure [BiPAP], intubation and mechanical ventilation); Grade 5: death.
Time Frame From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Outcome Measure Data Not Reported
20.Secondary Outcome
Title Number of Participants With Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) Graded According to American Society for Transplantation and Cellular Therapy (ASTCT) Criteria
Hide Description ICANS Grade 1: immune effector cell encephalopathy (ICE) score 7-9, participant awakens spontaneously; Grade 2: ICE score 3-6, participant awakens to voice; Grade 3: ICE score 0-2, participant awakens only to tactile stimulus, any clinical seizure focal or generalized that resolved rapidly or nonconvulsive seizures on electroencephalography that resolve with intervention or focal/local edema on neuroimaging; Grade 4: ICE score 0 (participant is unarousable and unable to perform ICE), participant unarousable or requires vigorous or repetitive tactile stimuli to arouse, life-threatening prolonged seizure (>5 min), repetitive clinical or electrical seizures without return to baseline in between, deep focal motor weakness, diffuse cerebral edema on neuroimaging; decerebrate/decorticate posturing; cranial nerve VI palsy; papilledema, Cushing's triad; Grade 5: death. ICE: measures alterations in speech, orientation, handwriting, attention and receptive aphasia.
Time Frame From the date of first dose up to 90 days after last dose or new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Outcome Measure Data Not Reported
21.Secondary Outcome
Title Serum Concentration of Elranatamab
Hide Description Total and free concentrations of Elranatamab on Cycle 4 Day 1 (C4D1) and Cycle 7 Day 1 (C7D1) were reported in this outcome measure.
Time Frame Pre-dose on Day 1 of Cycle 4 and Pre-dose on Day 1 of Cycle 7
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) analysis set was a subset of safety analysis set and included participants who had at least one post dose concentration measurement. Here, "Overall Number of Participants Analyzed" signifies maximum participants evaluable for this outcome measure.
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description:
BCMA-naïve participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
BCMA-exposed participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
Overall Number of Participants Analyzed 38 21
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms per milliliter (ng/mL)
Total elranatamab concentrations (C4D1) Number Analyzed 37 participants 21 participants
31100
(49%)
22840
(63%)
Total elranatamab concentrations (C7D1) Number Analyzed 29 participants 9 participants
37960
(47%)
29880
(77%)
Free elranatamab concentrations (C4D1) Number Analyzed 38 participants 21 participants
19090
(89%)
16170
(114%)
Free elranatamab concentrations (C7D1) Number Analyzed 29 participants 9 participants
32830
(81%)
29880
(49%)
22.Secondary Outcome
Title Percentage of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb) Against Elranatamab
Hide Description [Not Specified]
Time Frame From the date of first dose up to 20.14 months
Outcome Measure Data Not Reported
Time Frame From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
Adverse Event Reporting Description Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
 
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description BCMA-naïve participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8. BCMA-exposed participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
All-Cause Mortality
Cohort A Cohort B
Affected / at Risk (%) Affected / at Risk (%)
Total   43/123 (34.96%)   30/64 (46.88%) 
Hide Serious Adverse Events
Cohort A Cohort B
Affected / at Risk (%) Affected / at Risk (%)
Total   84/123 (68.29%)   44/64 (68.75%) 
Blood and lymphatic system disorders     
Anemia * 1  5/123 (4.07%)  3/64 (4.69%) 
Aplasia pure red cell * 1  1/123 (0.81%)  1/64 (1.56%) 
Febrile neutropenia * 1  3/123 (2.44%)  1/64 (1.56%) 
Neutropenia * 1  1/123 (0.81%)  1/64 (1.56%) 
Thrombocytopenia * 1  2/123 (1.63%)  1/64 (1.56%) 
Cardiac disorders     
Angina pectoris * 1  0/123 (0.00%)  1/64 (1.56%) 
Atrial fibrillation * 1  1/123 (0.81%)  0/64 (0.00%) 
Cardiac failure acute * 1  0/123 (0.00%)  1/64 (1.56%) 
Cardio-respiratory arrest * 1  1/123 (0.81%)  0/64 (0.00%) 
Cardiogenic shock * 1  0/123 (0.00%)  1/64 (1.56%) 
Cardiopulmonary failure * 1  1/123 (0.81%)  0/64 (0.00%) 
Sinus bradycardia * 1  1/123 (0.81%)  0/64 (0.00%) 
Sinus tachycardia * 1  0/123 (0.00%)  2/64 (3.13%) 
Ear and labyrinth disorders     
Vertigo * 1  1/123 (0.81%)  0/64 (0.00%) 
Eye disorders     
Blindness * 1  0/123 (0.00%)  1/64 (1.56%) 
Retinal detachment * 1  1/123 (0.81%)  0/64 (0.00%) 
Visual impairment * 1  1/123 (0.81%)  0/64 (0.00%) 
Gastrointestinal disorders     
Abdominal pain upper * 1  0/123 (0.00%)  1/64 (1.56%) 
Constipation * 1  0/123 (0.00%)  1/64 (1.56%) 
Diarrhoea * 1  1/123 (0.81%)  2/64 (3.13%) 
Diarrhoea haemorrhagic * 1  0/123 (0.00%)  1/64 (1.56%) 
Hiatus hernia * 1  0/123 (0.00%)  1/64 (1.56%) 
Oesophagitis * 1  0/123 (0.00%)  1/64 (1.56%) 
Upper gastrointestinal haemorrhage * 1  1/123 (0.81%)  0/64 (0.00%) 
Vomiting * 1  1/123 (0.81%)  0/64 (0.00%) 
General disorders     
Asthenia * 1  1/123 (0.81%)  0/64 (0.00%) 
Disease progression * 1  6/123 (4.88%)  4/64 (6.25%) 
General physical health deterioration * 1  1/123 (0.81%)  1/64 (1.56%) 
Inflammation * 1  1/123 (0.81%)  1/64 (1.56%) 
Injection site reaction * 1  0/123 (0.00%)  1/64 (1.56%) 
Mucosal inflammation * 1  1/123 (0.81%)  0/64 (0.00%) 
Multiple organ dysfunction syndrome * 1  0/123 (0.00%)  1/64 (1.56%) 
Non-cardiac chest pain * 1  1/123 (0.81%)  0/64 (0.00%) 
Oedema peripheral * 1  1/123 (0.81%)  0/64 (0.00%) 
Pyrexia * 1  3/123 (2.44%)  1/64 (1.56%) 
Hepatobiliary disorders     
Hepatitis fulminant * 1  1/123 (0.81%)  0/64 (0.00%) 
Immune system disorders     
Cytokine release syndrome * 1  16/123 (13.01%)  7/64 (10.94%) 
Hypogammaglobulinaemia * 1  0/123 (0.00%)  1/64 (1.56%) 
Infections and infestations     
Abscess limb * 1  1/123 (0.81%)  0/64 (0.00%) 
Adenovirus infection * 1  1/123 (0.81%)  0/64 (0.00%) 
Appendicitis * 1  1/123 (0.81%)  0/64 (0.00%) 
Aspergilloma * 1  0/123 (0.00%)  1/64 (1.56%) 
Bacteraemia * 1  3/123 (2.44%)  1/64 (1.56%) 
Bronchitis * 1  0/123 (0.00%)  1/64 (1.56%) 
Bronchitis viral * 1  0/123 (0.00%)  1/64 (1.56%) 
COVID-19 * 1  1/123 (0.81%)  4/64 (6.25%) 
COVID-19 pneumonia * 1  15/123 (12.20%)  7/64 (10.94%) 
Cellulitis * 1  0/123 (0.00%)  1/64 (1.56%) 
Chronic sinusitis * 1  1/123 (0.81%)  0/64 (0.00%) 
Clostridium difficile infection * 1  0/123 (0.00%)  1/64 (1.56%) 
Cytomegalovirus infection reactivation * 1  1/123 (0.81%)  1/64 (1.56%) 
Device related bacteraemia * 1  2/123 (1.63%)  0/64 (0.00%) 
Device related sepsis * 1  0/123 (0.00%)  1/64 (1.56%) 
Enterocolitis infectious * 1  1/123 (0.81%)  0/64 (0.00%) 
Escherichia sepsis * 1  1/123 (0.81%)  0/64 (0.00%) 
Escherichia urinary tract infection * 1  1/123 (0.81%)  0/64 (0.00%) 
Herpes virus infection * 1  0/123 (0.00%)  1/64 (1.56%) 
Histoplasmosis * 1  1/123 (0.81%)  0/64 (0.00%) 
Klebsiella sepsis * 1  2/123 (1.63%)  0/64 (0.00%) 
Lower respiratory tract infection viral * 1  1/123 (0.81%)  0/64 (0.00%) 
Parvovirus B19 infection * 1  0/123 (0.00%)  1/64 (1.56%) 
Pneumocystis jirovecii pneumonia * 1  6/123 (4.88%)  1/64 (1.56%) 
Pneumonia * 1  9/123 (7.32%)  3/64 (4.69%) 
Pneumonia adenoviral * 1  1/123 (0.81%)  0/64 (0.00%) 
Pneumonia bacterial * 1  3/123 (2.44%)  1/64 (1.56%) 
Pneumonia cytomegaloviral * 1  1/123 (0.81%)  0/64 (0.00%) 
Pneumonia fungal * 1  0/123 (0.00%)  1/64 (1.56%) 
Pneumonia influenzal * 1  1/123 (0.81%)  0/64 (0.00%) 
Pneumonia pseudomonal * 1  1/123 (0.81%)  0/64 (0.00%) 
Pneumonia viral * 1  1/123 (0.81%)  0/64 (0.00%) 
Post-acute COVID-19 syndrome * 1  0/123 (0.00%)  1/64 (1.56%) 
Pseudomonal sepsis * 1  1/123 (0.81%)  0/64 (0.00%) 
Pyelonephritis * 1  1/123 (0.81%)  2/64 (3.13%) 
Pyelonephritis acute * 1  1/123 (0.81%)  0/64 (0.00%) 
Rhinovirus infection * 1  1/123 (0.81%)  0/64 (0.00%) 
Sepsis * 1  5/123 (4.07%)  2/64 (3.13%) 
Septic shock * 1  4/123 (3.25%)  2/64 (3.13%) 
Sinusitis * 1  3/123 (2.44%)  0/64 (0.00%) 
Skin infection * 1  1/123 (0.81%)  0/64 (0.00%) 
Staphylococcal bacteraemia * 1  1/123 (0.81%)  0/64 (0.00%) 
Staphylococcal sepsis * 1  0/123 (0.00%)  1/64 (1.56%) 
Streptococcal sepsis * 1  1/123 (0.81%)  0/64 (0.00%) 
Urinary tract infection * 1  3/123 (2.44%)  2/64 (3.13%) 
Urinary tract infection bacterial * 1  1/123 (0.81%)  0/64 (0.00%) 
Urosepsis * 1  1/123 (0.81%)  0/64 (0.00%) 
Viral infection * 1  1/123 (0.81%)  0/64 (0.00%) 
Viral upper respiratory tract infection * 1  1/123 (0.81%)  0/64 (0.00%) 
Injury, poisoning and procedural complications     
Fall * 1  0/123 (0.00%)  2/64 (3.13%) 
Humerus fracture * 1  1/123 (0.81%)  0/64 (0.00%) 
Procedural pneumothorax * 1  1/123 (0.81%)  0/64 (0.00%) 
Upper limb fracture * 1  1/123 (0.81%)  0/64 (0.00%) 
Investigations     
Blood creatinine increased * 1  1/123 (0.81%)  0/64 (0.00%) 
Parvovirus B19 test positive * 1  0/123 (0.00%)  1/64 (1.56%) 
SARS-CoV-2 antibody test positive * 1  0/123 (0.00%)  1/64 (1.56%) 
SARS-CoV-2 test positive * 1  2/123 (1.63%)  2/64 (3.13%) 
Weight decreased * 1  1/123 (0.81%)  0/64 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  1/123 (0.81%)  0/64 (0.00%) 
Dehydration * 1  1/123 (0.81%)  0/64 (0.00%) 
Failure to thrive * 1  1/123 (0.81%)  0/64 (0.00%) 
Hypercalcaemia * 1  0/123 (0.00%)  1/64 (1.56%) 
Hyperglycaemia * 1  0/123 (0.00%)  1/64 (1.56%) 
Hyperuricaemia * 1  0/123 (0.00%)  1/64 (1.56%) 
Hypokalaemia * 1  1/123 (0.81%)  0/64 (0.00%) 
Hyponatraemia * 1  0/123 (0.00%)  1/64 (1.56%) 
Tumor lysis syndrome * 1  1/123 (0.81%)  0/64 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  2/123 (1.63%)  0/64 (0.00%) 
Back pain * 1  0/123 (0.00%)  1/64 (1.56%) 
Bone pain * 1  1/123 (0.81%)  1/64 (1.56%) 
Muscular weakness * 1  0/123 (0.00%)  1/64 (1.56%) 
Myositis * 1  1/123 (0.81%)  0/64 (0.00%) 
Pathological fracture * 1  1/123 (0.81%)  0/64 (0.00%) 
Polyarthritis * 1  1/123 (0.81%)  0/64 (0.00%) 
Polymyalgia rheumatica * 1  1/123 (0.81%)  0/64 (0.00%) 
Sarcopenia * 1  1/123 (0.81%)  0/64 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain * 1  1/123 (0.81%)  0/64 (0.00%) 
Metastases to meninges * 1  1/123 (0.81%)  0/64 (0.00%) 
Neoplasm progression * 1  1/123 (0.81%)  0/64 (0.00%) 
Plasma cell myeloma * 1  2/123 (1.63%)  4/64 (6.25%) 
Plasma cell myeloma refractory * 1  1/123 (0.81%)  0/64 (0.00%) 
Squamous cell carcinoma of skin * 1  1/123 (0.81%)  0/64 (0.00%) 
Nervous system disorders     
Altered state of consciousness * 1  0/123 (0.00%)  1/64 (1.56%) 
Ataxia * 1  0/123 (0.00%)  1/64 (1.56%) 
Depressed level of consciousness * 1  0/123 (0.00%)  1/64 (1.56%) 
Guillain-Barre syndrome * 1  1/123 (0.81%)  0/64 (0.00%) 
Immune effector cell-associated neurotoxicity syndrome * 1  0/123 (0.00%)  2/64 (3.13%) 
Metabolic encephalopathy * 1  1/123 (0.81%)  0/64 (0.00%) 
Syncope * 1  3/123 (2.44%)  0/64 (0.00%) 
Toxic encephalopathy * 1  0/123 (0.00%)  1/64 (1.56%) 
Trigeminal neuralgia * 1  0/123 (0.00%)  1/64 (1.56%) 
Psychiatric disorders     
Confusional state * 1  2/123 (1.63%)  0/64 (0.00%) 
Mental status changes * 1  1/123 (0.81%)  0/64 (0.00%) 
Renal and urinary disorders     
Acute kidney injury * 1  4/123 (3.25%)  2/64 (3.13%) 
Renal failure * 1  1/123 (0.81%)  0/64 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome * 1  1/123 (0.81%)  0/64 (0.00%) 
Cough * 1  1/123 (0.81%)  0/64 (0.00%) 
Dyspnoea * 1  2/123 (1.63%)  1/64 (1.56%) 
Hypoxia * 1  1/123 (0.81%)  1/64 (1.56%) 
Pleural effusion * 1  0/123 (0.00%)  1/64 (1.56%) 
Pneumonitis * 1  0/123 (0.00%)  1/64 (1.56%) 
Pulmonary embolism * 1  0/123 (0.00%)  1/64 (1.56%) 
Respiratory distress * 1  0/123 (0.00%)  1/64 (1.56%) 
Respiratory failure * 1  2/123 (1.63%)  0/64 (0.00%) 
Vascular disorders     
Hypertension * 1  0/123 (0.00%)  2/64 (3.13%) 
1
Term from vocabulary, MedDRA v25.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort A Cohort B
Affected / at Risk (%) Affected / at Risk (%)
Total   123/123 (100.00%)   63/64 (98.44%) 
Blood and lymphatic system disorders     
Anaemia * 1  58/123 (47.15%)  39/64 (60.94%) 
Leukopenia * 1  17/123 (13.82%)  12/64 (18.75%) 
Lymphopenia * 1  32/123 (26.02%)  22/64 (34.38%) 
Neutropenia * 1  59/123 (47.97%)  24/64 (37.50%) 
Thrombocytopenia * 1  36/123 (29.27%)  27/64 (42.19%) 
Cardiac disorders     
Sinus tachycardia * 1  6/123 (4.88%)  5/64 (7.81%) 
Tachycardia * 1  7/123 (5.69%)  5/64 (7.81%) 
Gastrointestinal disorders     
Abdominal pain * 1  6/123 (4.88%)  5/64 (7.81%) 
Constipation * 1  16/123 (13.01%)  11/64 (17.19%) 
Diarrhoea * 1  47/123 (38.21%)  18/64 (28.13%) 
Dry mouth * 1  6/123 (4.88%)  4/64 (6.25%) 
Nausea * 1  32/123 (26.02%)  9/64 (14.06%) 
Vomiting * 1  19/123 (15.45%)  8/64 (12.50%) 
General disorders     
Asthenia * 1  22/123 (17.89%)  10/64 (15.63%) 
Chills * 1  10/123 (8.13%)  2/64 (3.13%) 
Fatigue * 1  42/123 (34.15%)  9/64 (14.06%) 
Injection site erythema * 1  9/123 (7.32%)  5/64 (7.81%) 
Injection site reaction * 1  32/123 (26.02%)  8/64 (12.50%) 
Oedema peripheral * 1  17/123 (13.82%)  3/64 (4.69%) 
Pain * 1  5/123 (4.07%)  5/64 (7.81%) 
Pyrexia * 1  27/123 (21.95%)  11/64 (17.19%) 
Immune system disorders     
Cytokine release syndrome * 1  64/123 (52.03%)  34/64 (53.13%) 
Hypogammaglobulinaemia * 1  11/123 (8.94%)  5/64 (7.81%) 
Infections and infestations     
Pneumonia * 1  7/123 (5.69%)  6/64 (9.38%) 
Sinusitis * 1  10/123 (8.13%)  6/64 (9.38%) 
Upper respiratory tract infection * 1  22/123 (17.89%)  7/64 (10.94%) 
Urinary tract infection * 1  8/123 (6.50%)  6/64 (9.38%) 
Injury, poisoning and procedural complications     
Fall * 1  14/123 (11.38%)  5/64 (7.81%) 
Investigations     
Alanine aminotransferase increased * 1  16/123 (13.01%)  9/64 (14.06%) 
Aspartate aminotransferase increased * 1  18/123 (14.63%)  7/64 (10.94%) 
Blood alkaline phosphatase increased * 1  8/123 (6.50%)  2/64 (3.13%) 
Blood creatinine increased * 1  12/123 (9.76%)  6/64 (9.38%) 
Blood lactate dehydrogenase increased * 1  7/123 (5.69%)  4/64 (6.25%) 
SARS-CoV-2 test positive * 1  27/123 (21.95%)  9/64 (14.06%) 
Weight decreased * 1  12/123 (9.76%)  3/64 (4.69%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  40/123 (32.52%)  11/64 (17.19%) 
Hypercalcaemia * 1  12/123 (9.76%)  4/64 (6.25%) 
Hyperglycaemia * 1  5/123 (4.07%)  5/64 (7.81%) 
Hypoalbuminaemia * 1  4/123 (3.25%)  8/64 (12.50%) 
Hypocalcaemia * 1  7/123 (5.69%)  8/64 (12.50%) 
Hypokalaemia * 1  28/123 (22.76%)  11/64 (17.19%) 
Hypomagnesaemia * 1  10/123 (8.13%)  9/64 (14.06%) 
Hyponatraemia * 1  11/123 (8.94%)  9/64 (14.06%) 
Hypophosphataemia * 1  7/123 (5.69%)  5/64 (7.81%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  18/123 (14.63%)  8/64 (12.50%) 
Back pain * 1  15/123 (12.20%)  4/64 (6.25%) 
Bone pain * 1  6/123 (4.88%)  10/64 (15.63%) 
Muscle spasms * 1  9/123 (7.32%)  3/64 (4.69%) 
Myalgia * 1  10/123 (8.13%)  1/64 (1.56%) 
Pain in extremity * 1  9/123 (7.32%)  11/64 (17.19%) 
Nervous system disorders     
Dizziness * 1  13/123 (10.57%)  2/64 (3.13%) 
Headache * 1  27/123 (21.95%)  7/64 (10.94%) 
Psychiatric disorders     
Insomnia * 1  16/123 (13.01%)  8/64 (12.50%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  27/123 (21.95%)  11/64 (17.19%) 
Dyspnoea * 1  12/123 (9.76%)  9/64 (14.06%) 
Nasal congestion * 1  12/123 (9.76%)  5/64 (7.81%) 
Productive cough * 1  12/123 (9.76%)  0/64 (0.00%) 
Skin and subcutaneous tissue disorders     
Dry skin * 1  20/123 (16.26%)  6/64 (9.38%) 
Erythema * 1  12/123 (9.76%)  5/64 (7.81%) 
Pruritus * 1  10/123 (8.13%)  5/64 (7.81%) 
Rash * 1  10/123 (8.13%)  4/64 (6.25%) 
Rash maculo-papular * 1  9/123 (7.32%)  6/64 (9.38%) 
Skin exfoliation * 1  13/123 (10.57%)  6/64 (9.38%) 
Vascular disorders     
Hypertension * 1  10/123 (8.13%)  3/64 (4.69%) 
Hypotension * 1  12/123 (9.76%)  5/64 (7.81%) 
1
Term from vocabulary, MedDRA v25.0
*
Indicates events were collected by non-systematic assessment
Due to character limitation in outcome measure description, SPD definition is provided here. SPD was defined as the sum of the products of the maximal perpendicular diameters of measured lesions. Data for only those primary and secondary outcome measures whose analysis is complete and final have been reported. Data for remaining secondary outcome measures will be posted upon completion of analysis at secondary completion date.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04649359    
Other Study ID Numbers: C1071003
2020-004533-21 ( EudraCT Number )
MagnetisMM-3 ( Other Identifier: Alias Study Number )
First Submitted: November 6, 2020
First Posted: December 2, 2020
Results First Submitted: June 15, 2023
Results First Posted: October 25, 2023
Last Update Posted: April 30, 2024