Actively Recruiting
Frontline T-cell Engager vs Autologous Stem Cell Transplant (ASCT) and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma
Led by SCRI Development Innovations, LLC · Updated on 2026-04-24
100
Participants Needed
11
Research Sites
399 weeks
Total Duration
On this page
Sponsors
S
SCRI Development Innovations, LLC
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open-label, multi-site, Phase II randomized trial with response-adaptive design for newly diagnosed multiple myeloma (NDMM) participants who have had prior induction therapy. The primary objective of this study is to compare the rates of achieving undetectable measurable residual disease (MRD) in the bone marrow with elranatamab and daratumumab employed as post-induction consolidation and maintenance treatment (Arm A) versus autologous stem cell transplant (ASCT) followed by lenalidomide and daratumumab treatment (Arm B).
CONDITIONS
Official Title
Frontline T-cell Engager vs Autologous Stem Cell Transplant (ASCT) and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years with no upper age limit
- Newly diagnosed multiple myeloma diagnosed within the last 12 months requiring treatment
- Eligible for autologous stem cell transplant as assessed by investigator
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Prior induction therapy with one proteasome inhibitor, lenalidomide, and anti-CD38 monoclonal antibody for 16-24 weeks achieving at least partial response
- Measurable disease by specified serum or urine monoclonal protein criteria at diagnosis
- Trackable clonogenic sequence identified for measurable residual disease testing
- Clinical laboratory values meeting specified hemoglobin, platelet, neutrophil, liver, kidney, and calcium levels at screening and treatment start
- Completion of standard stem cell mobilization and collection with minimum cell count prior to study
- Women of childbearing potential must have negative pregnancy tests and agree to contraception and other related requirements
- Men must agree to use condoms and not donate sperm during and after study treatment
- Willing and able to comply with study lifestyle restrictions and sign informed consent
- Enrolled in Revlimid and elranatamab Risk Evaluation and Mitigation Strategy (REMS) programs
- Meet institution-specific criteria for ASCT eligibility
You will not qualify if you...
- Diagnosis of primary light chain amyloidosis, POEMS syndrome, Waldenstrom's macroglobulinemia, plasma cell leukemia, or CNS involvement by multiple myeloma
- Allergies or intolerance to study drugs or their ingredients
- Prior exposure to anti-BCMA therapy, epigenetic therapy, investigational drugs or devices within specified washout periods
- Active CNS involvement or meningeal signs of multiple myeloma without negative brain MRI and lumbar cytology
- Other active malignancies or recent cancers not considered cured within 24 months (with specified exceptions)
- Stroke or seizure within 6 months prior to consent
- Severe lung disease including COPD with FEV1 <50% predicted or moderate/severe asthma in past 2 years
- Prior allogeneic bone marrow, hematopoietic stem cell, or solid organ transplant
- Pregnancy, breastfeeding, or planning pregnancy during or shortly after study
- Cardiac conditions including severe heart failure, recent myocardial infarction, significant arrhythmias, or severe cardiomyopathy
- History of HIV/AIDS
- Active or recent infections including unresolved COVID-19
- Hepatitis B or active hepatitis C infection without successful treatment
- Major surgery within 14 days before treatment or planned during treatment period
- Contraindications or intolerance to supportive care medications or study drugs
- Significant neuropathy (Grade 3-4 or Grade 2 with pain)
- History of Guillain-Barre Syndrome or variant
- Medical or psychiatric conditions likely to interfere with study or pose hazard as judged by investigator
- History of non-compliance with medical treatments prior to study enrollment
AI-Screening
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Trial Site Locations
Total: 11 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
3
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
4
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
5
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
Actively Recruiting
6
The Ohio State University- The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States, 43210
Actively Recruiting
7
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
8
University of Texas Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
9
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
10
University of Wisconsin Clinical Science Center
Madison, Wisconsin, United States, 53792
Actively Recruiting
11
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
S
Sarah Cannon Development Innovations, LLC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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