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

Official Summary

The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years

Eligibility Requirements

• Minimum Age: 18 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 854 participants

Study Arms

• Arm A - Part 1 (EXPERIMENTAL)
  Elranatamab
• Arm B - Part 1 (ACTIVE_COMPARATOR)
  Lenalidomide
• Arm B - Part 2 (ACTIVE_COMPARATOR)
  Lenalidomide
• Arm C - Part 2 (EXPERIMENTAL)
  Elranatamab

Interventions

• DRUG: Elranatamab — BCMA-CD3 bispecific antibody
• DRUG: Lenalidomide — Immunomodulatory drug
• DRUG: Lenalidomide — Immunomodulatory drug
• DRUG: Elranatamab — BCMA-CD3 bispecific antibody

Primary Outcomes

• Progression Free Survival (Assessed for up to approximately 5 years)

Secondary Outcomes

• Minimal residual disease Negative rate (12 months after randomization)
• Progression Free Survival by BICR per IMWG in IMWG 2025 high-risk participants (Assessed up to approximately 5 years)
• PFS by BICR per IMWG in IMWG 2025 standard-risk participant (Assessed up to approximately 5 years)
• Overall Survival (Assessed for up to approximately 5 years)
• MRD-negative rate per IMWG 2025 (12 months after randomization)

Eligibility Criteria

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)

Trial Locations

• Banner Gateway Medical Center, Gilbert, Arizona, United States
• Banner Gateway Medical Pavilion, Gilbert, Arizona, United States
• Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
• Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
• UCLA Department of Medicine - Hematology/Oncology, Los Angeles, California, United States
• UCLA Hematology/Oncology, Los Angeles, California, United States
• Santa Monica UCLA Medical Center & Orthopaedic Hospital, Santa Monica, California, United States
• UCLA Hematology/Oncology - Santa Monica, Santa Monica, California, United States
• Georgetown University Medical Center, Washington D.C., District of Columbia, United States
• Miami Cancer Institute at Baptist Health, Inc., Miami, Florida, United States
• ...and 10 more locations

Study Officials

• Pfizer CT.gov Call Center — STUDY_DIRECTOR
  Pfizer

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