Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant

Purpose

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

Condition

  • Multiple Myeloma

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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)

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Georgetown University Medical Center
Washington, District of Columbia 20007

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Detailed Description

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.