A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135), Daratumumab, and Lenalidomide Compared With Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant (MagnetisMM-6)
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| ClinicalTrials.gov Identifier: NCT05623020 |
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Recruitment Status :
Recruiting
First Posted : November 21, 2022
Last Update Posted : April 16, 2024
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Brief Summary:
Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity. The main purpose of the study is to evaluate if the combination of Elranatamab, Daratumumab and Lenalidomide offers superior clinical benefit compared with the combination of Daratumumab, Lenalidomide and Dexamethasone in people with multiple myeloma.
There are 2 parts to this study. Part 1 will characterize the safety and tolerability of elranatamab when administered in combination with daratumumab and lenalidomide and will identify the optimal dose(s) of the combination regimen. Part 2 of the study will evaluate the minimal residual disease (MRD) negativity rate and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, lenalidomide, and dexamethasone in participants with newly diagnosed transplant-ineligible multiple myeloma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma | Drug: Elranatamab Drug: Daratumumab Drug: Lenalidomide Drug: Dexamethasone | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 966 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | MAGNETISMM-6: AN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE VERSUS DARATUMUMAB + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE PARTICIPANTS WITH NEWLY-DIAGNOSED MULTIPLE MYELOMA |
| Actual Study Start Date : | November 10, 2022 |
| Estimated Primary Completion Date : | March 31, 2028 |
| Estimated Study Completion Date : | November 29, 2031 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
| Arm | Intervention/treatment |
|---|---|
| Experimental: Part 1, Dose Level 1: Elranatamab + Daratumumab + Lenalidomide |
Drug: Elranatamab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized. Drug: Daratumumab Part 1 Dose Level 1 is not randomized. All other cohorts are randomized. Drug: Lenalidomide Part 1 Dose Level 1 is not randomized. All other cohorts are randomized. |
| Experimental: Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + Lenalidomide |
Drug: Elranatamab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized. Drug: Daratumumab Part 1 Dose Level 1 is not randomized. All other cohorts are randomized. Drug: Lenalidomide Part 1 Dose Level 1 is not randomized. All other cohorts are randomized. |
| Experimental: Part 2 Randomized Arm A: Elranatamab + Daratumumab + Lenalidomide |
Drug: Elranatamab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized. Drug: Daratumumab Part 1 Dose Level 1 is not randomized. All other cohorts are randomized. Drug: Lenalidomide Part 1 Dose Level 1 is not randomized. All other cohorts are randomized. |
| Active Comparator: Part 2 Randomized Arm B: Daratumumab + Lenalidomide + Dexamethasone |
Drug: Daratumumab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized. Drug: Lenalidomide Part 1 Dose Level 1 is not randomized. All other cohorts are randomized. Drug: Dexamethasone Randomized |
Primary Outcome Measures :
- Part 1 Dose Limiting Toxicity [ Time Frame: From the first dose of elranatamab/first full dose in combination with EDR until 28 days (+/- visit window) from the first administration of elranatamab 76 with daratumumab and lenalidomide ]
- Part 2: Progression free survival by blinded independent central review [ Time Frame: From randomization up to 73 months. ]
- Part 2: Sustained minimal residual disease negativity rate [ Time Frame: For at least 12 months after date of initial MRD-negative status ]
Secondary Outcome Measures :
- Overall Survival [ Time Frame: From date of randomization up to 73 months ]
- Overall minimal residual disease negativity rate [ Time Frame: From date of randomization up to 73 months ]
- Duration of minimal residual disease negativity (Part 2) [ Time Frame: From date of minimal residual disease negative status up to 73 months ]
- PFS by investigator [ Time Frame: From date of randomization up to 73 months ]
- PFS2 by investigator (Part 2) [ Time Frame: From the date of randomization up to 73 months ]
- Objective Response Rate [ Time Frame: From the date of randomization up to 73 months ]
- Complete Response Rate [ Time Frame: From the date of randomization up to 73 months ]
- Time to Response [ Time Frame: From the date of randomization to date of confirmed objective response up to 73 months ]
- Duration of Response [ Time Frame: From the date of confirmed objective response up to 73 months ]
- Duration of Complete Response [ Time Frame: From the date of confirmed complete response up to 73 months ]
- Frequency of treatment-emergent adverse events [ Time Frame: From the date of first dose of study intervention up to 73 months ]
- Frequency of abnormal laboratory results [ Time Frame: From the date of first dose of study intervention up to 73 months ]
- Elranatamab pharmacokinetics by pre-dose concentrations when used with lenalidomide and daratumumab [ Time Frame: From date of first dose of study intervention up to 73 months ]Pharmacokinetics of elranatamab (trough concentrations of elranatamab)
- Elranatamab pharmacokinetics by post-dose concentrations when used with lenalidomide and daratumumab [ Time Frame: From date of first dose of study intervention up to 73 months ]Pharmacokinetics of elranatamab (post-dose serum concentrations of elranatamab)
- Incidence of Anti-Drug Antibody and Neutralizing Antibody against elranatamab [ Time Frame: From date of first dose of study intervention up to 73 months ]Immunogenicity of elranatamab
- Titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab [ Time Frame: From date of first dose of study intervention up to 73 months ]Immunogenicity of elranatamab
- Part 2: Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire -Myeloma 20 [ Time Frame: From date the informed consent is signed up to 73 months ]Higher scores on the functioning subscales (body image, future perspective) represent higher levels of functioning, whereas higher scores on the symptom subscales (disease symptoms, side effects) represent a greater presence of symptoms
- Part 2: Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 [ Time Frame: From date the informed consent is signed up to 73 months ]Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on the symptom scales/items represent a greater presence of symptoms.
- Part 1: Daratumumab and lenalidomide pharmacokinetics by pre-dose concentrations in combination with elranatamab [ Time Frame: From date of first dose of study intervention up to 73 months ]Pharmacokinetics of daratumumab and lenalidomide (trough concentrations of daratumumab and lenalidomide)
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of multiple myeloma (MM) as defined by IMWG criteria (Rajkumar et al., 2014)
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Measurable disease based on IMWG criteria as defined by at least 1 of the following:
- Serum M-protein ≥0.5 g/dL;
- Urinary M-protein excretion ≥200 mg/24 hours;
- Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
- Part 1: Participants with relapsed/refractory multiple myeloma (RRMM) who have received 1-2 prior lines of therapy including at least one immunomodulatory drug and one proteasome inhibitor: or participants with newly-diagnosed multiple myeloma (NDMM) that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age <65 years with comorbidities impacting the possibility of transplant.
- Part 2: participants with newly-diagnosed multiple myeloma that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age <65 years with comorbidities impacting the possibility of transplant
- ECOG performance status ≤2.
- Not pregnant and willing to use contraception
- For participants with RRMM: Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
Exclusion Criteria:
- Smoldering Multiple Myeloma.
- Monoclonal gammopathy of undetermined significance.
- Waldenströms Macroglobulinemia
- Plasma cell leukemia.
- Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19/SARS-CoV-2, HBV, HCV, and known HIV or AIDS-related illness.
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or Stage 0/1 with minimal risk of recurrence per investigator.
- For participants with RRMM: Previous treatment with a BCMA-directed therapy or anti-CD38-directed therapy within 6 months preceding the first dose of study intervention in this study. Stem cell transplant ≤3 months prior to first dose of study intervention or active GVHD.
- For participants with NDMM: Previous systemic treatment for MM except for a short course of corticosteroids (ie, up to 4 days of 40 mg dexamethasone or equivalent before the first dose of study intervention).
- Live attenuated vaccine administered within 4 weeks of the first dose of study intervention.
- Administration of investigational product (eg, drug or vaccine) concurrent with study intervention or within 30 days (or as determined by the local requirement) preceding the first dose of study intervention used in this study.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05623020
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Locations
Show 73 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT05623020 |
| Other Study ID Numbers: |
C1071006 2021-000803-20 ( EudraCT Number ) |
| First Posted: | November 21, 2022 Key Record Dates |
| Last Update Posted: | April 16, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests. |
| URL: | https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
Keywords provided by Pfizer:
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Elranatamab PF-06863135 B-Cell Maturation Antigen Daratumumab |
Lenalidomide Multiple myeloma MagnetisMM-6 |
Additional relevant MeSH terms:
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Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Dexamethasone |
Lenalidomide Daratumumab Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Immunologic Factors Angiogenesis Inhibitors |