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

Description

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

Conditions

Multiple Myeloma

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Multiple Myeloma
Intervention / Treatment

-

Contacts and Locations

Gilbert

Banner Gateway Medical Center, Gilbert, Arizona, United States, 85234

Gilbert

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States, 85234

Gilbert

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States, 85234

Los Angeles

Ronald Reagan UCLA Medical Center, Los Angeles, California, United States, 90095

Los Angeles

UCLA Hematology/Oncology - Westwood (Building 200 Suite 120), Los Angeles, California, United States, 90095

Washington

Georgetown University Medical Center, Washington, District of Columbia, United States, 20007

Miami

Miami Cancer Institute at Baptist Health, Inc., Miami, Florida, United States, 33176

Atlanta

Emory University Hospital Midtown, Atlanta, Georgia, United States, 30308

Atlanta

Emory University Hospital, Atlanta, Georgia, United States, 30322

Atlanta

Investigational Drug Service, Emory University Clinic, Atlanta, Georgia, United States, 30322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pfizer,

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

2029-10-31