Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant (MagnetisMM-7)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05317416 |
Recruitment Status :
Recruiting
First Posted : April 7, 2022
Last Update Posted : April 30, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Myeloma | Drug: Elranatamab Drug: Lenalidomide | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 760 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION |
Actual Study Start Date : | March 25, 2022 |
Estimated Primary Completion Date : | August 4, 2027 |
Estimated Study Completion Date : | October 31, 2029 |
Arm | Intervention/treatment |
---|---|
Experimental: Arm A - Part 1
Elranatamab
|
Drug: Elranatamab
BCMA-CD3 bispecific antibody |
Active Comparator: Arm B - Part 1
Lenalidomide
|
Drug: Lenalidomide
Immunomodulatory drug |
Active Comparator: Arm B - Part 2
Lenalidomide
|
Drug: Lenalidomide
Immunomodulatory drug |
Experimental: Arm C - Part 2
Elranatamab
|
Drug: Elranatamab
BCMA-CD3 bispecific antibody |
- Progression Free Survival [ Time Frame: Assessed for up to approximately 5 years ]Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria
- Overall Survival [ Time Frame: Assessed for up to approximately 5 years ]Defined as the time from randomization until death due to any cause
- Minimal Residual Disease negativity rate [ Time Frame: 12 months after randomization ]Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing
- Sustained MRD negativity rate [ Time Frame: 24 months after randomization ]Sustained Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing
- Progression Free Survival [ Time Frame: Assessed for up to approximately 5 years ]Progression Free Survival by investigator per IMWG response criteria
- Overall minimal residual disease negativity rate [ Time Frame: Assessed for up to approximately 5 years ]Minimal residual disease negativity rate per IMWG criteria
- Duration of minimal residual disease negativity [ Time Frame: Assessed for up to approximately 5 years ]Minimal residual disease negativity per IMWG criteria
- Sustained minimal residual disease negativity rate [ Time Frame: Assessed for up to approximately 5 years ]Minimal residual disease negativity per IMWG criteria that has lasted a minimum of 12 months
- Complete response rate [ Time Frame: Assessed for up to approximately 5 years ]Complete response rate by blinded independent central review and by investigator per IMWG criteria
- Duration of complete response [ Time Frame: Assessed for up to approximately 5 years ]Duration of complete response by blinded independent central review and by investigator per IMWG criteria
- Frequency of adverse events [ Time Frame: Up to 90 days after last dose ]Adverse event as characterized by type, frequency, severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, seriousness and relationship to the study intervention
- Frequency of laboratory abnormalities [ Time Frame: Assessed for up to approximately 5 years ]
- Pre-dose concentrations of elranatamab [ Time Frame: Assessed for up to approximately 5 years ]Pharmacokinetics of elranatamab (trough concentrations of elranatamab)
- Post-dose concentrations of elranatamab [ Time Frame: Assessed for up to approximately 5 years ]Pharmacokinetics of elranatamab (Post-dose serum concentrations of elranatamab)"
- Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab [ Time Frame: Assessed for up to approximately 5 years ]Immunogenicity of elranatamab
- Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 [ Time Frame: Assessed for up to approximately 5 years ]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 symptom scales/items represent a greater presence of symptoms
- Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20 [ Time Frame: Assessed for up to approximately 5 years ]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
- Progression Free Survival 2 [ Time Frame: Assessed for up to approximately 5 years ]Progression Free Survival to the date of second objective disease progression by investigator per IMWG response criteria
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosis
- Part 1 patients must be MRD positive, Part 2 patients can be MRD negative or MRD positive
- History of induction therapy for newly diagnosed MM, followed by high dose therapy and autologous stem cell transplant. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT.
- Partial Response or better according to IMWG criteria at the time of randomization
- Must have an archival bone marrow aspirate sample(s) to identify the dominant malignant (index) clone by central laboratory NGS test (ClonoSEQ assay) that is used to track MRD status. This sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant.
- ECOG performance status ≤1
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1
- Not pregnant and willing to use contraception
Exclusion Criteria:
- Plasma cell leukemia
- Amyloidosis, Waldenström's macroglobulinemia
- POEMS syndrome
- Known active CNS involvement or clinical signs of myelomatous meningeal involvement
- Previous MM maintenance treatment
- Prior treatment with BCMA targeted therapy
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
- Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness
- Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
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): NCT05317416
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT05317416 |
Other Study ID Numbers: |
C1071007 2021-006052-14 ( EudraCT Number ) MagnetisMM-7 ( Other Identifier: Alias Study Number ) |
First Posted: | April 7, 2022 Key Record Dates |
Last Update Posted: | April 30, 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 |
BCMA Multiple Myeloma Newly diagnosed Elranatamab Targeted T-cell MagnetisMM MM7 Phase 3 |
B-cell Maturation Antigen monoclonal antibody Stem cell transplant Autologous stem cell transplant (ASCT) Hematologic disease Minimum residual disease Lenalidomide |
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 Lenalidomide Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |