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
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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 |
Baseline Characteristics
Arm/Group Title | Cohort A | Cohort B | Total | |
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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 | |
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.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 123 participants | 64 participants | 187 participants | |
Female |
55 44.7%
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34 53.1%
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89 47.6%
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Male |
68 55.3%
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30 46.9%
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98 52.4%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 123 participants | 64 participants | 187 participants | |
Hispanic or Latino |
11 8.9%
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7 10.9%
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18 9.6%
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Not Hispanic or Latino |
85 69.1%
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34 53.1%
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119 63.6%
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Unknown or Not Reported |
27 22.0%
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23 35.9%
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50 26.7%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 123 participants | 64 participants | 187 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
16 13.0%
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1 1.6%
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17 9.1%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
9 7.3%
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2 3.1%
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11 5.9%
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White |
72 58.5%
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44 68.8%
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116 62.0%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
26 21.1%
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17 26.6%
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43 23.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
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.
More Information
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
Name/Title: | Pfizer ClinicalTrials.gov Call Center |
Organization: | Pfizer Inc. |
Phone: | 1-800-718-1021 |
EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
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 |