ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

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

Quick Facts

Study Start:2022-03-25
Study Completion:2029-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05317416

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosis
  2. * Part 1 patients must be MRD positive, Part 2 patients can be MRD negative or MRD positive
  3. * 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.
  4. * Partial Response or better according to IMWG criteria at the time of randomization
  5. * 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.
  6. * ECOG performance status ≤1
  7. * Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1
  8. * Not pregnant and willing to use contraception
  1. * Plasma cell leukemia
  2. * Amyloidosis, Waldenström's macroglobulinemia
  3. * POEMS syndrome
  4. * Known active CNS involvement or clinical signs of myelomatous meningeal involvement
  5. * Previous MM maintenance treatment
  6. * Prior treatment with BCMA targeted therapy
  7. * 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
  8. * Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness
  9. * 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)

Contacts and Locations

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Banner Gateway Medical Center
Gilbert, Arizona, 85234
United States
Banner Gateway Medical Pavilion
Gilbert, Arizona, 85234
United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
United States
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, 90095
United States
UCLA Hematology/Oncology
Los Angeles, California, 90095
United States
UCLA Hematology/Oncology - Santa Monica
Los Angeles, California, 90404
United States
Santa Monica UCLA Medical Center & Orthopaedic Hospital
Santa Monica, California, 90404
United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
United States
Loyola University Chicago
Maywood, Illinois, 60153
United States
Ascentist Doctor Hospital
Leawood, Kansas, 66211
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
American Oncology Partners, P.A. Dba MidAmerica Cancer Care
Kansas City, Missouri, 64132
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
WMCHealth Advanced Physician Services
Hawthorne, New York, 10532
United States
Westchester Medical Center
Valhalla, New York, 10595
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
OhioHealth Arthur G.H. Bing, MD, Cancer Center
Columbus, Ohio, 43214
United States
OhioHealth Research Institute
Columbus, Ohio, 43214
United States
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, 43214
United States
Baylor University Medical Center
Dallas, Texas, 75246
United States
Baylor Scott & White Medical Center - Temple
Temple, Texas, 76508
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-25
Study Completion Date2029-10-31

Study Record Updates

Study Start Date2022-03-25
Study Completion Date2029-10-31

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Multiple Myeloma