NCT06974786 · SCRI Development Innovations, LLC
Frontline T-cell Engager vs Autologous Stem Cell Transplant (ASCT) and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma
(FASTER)
What this study is about
This is an where both patients and doctors know the treatment given, multi-site, Phase II randomly assigned trial with response-adaptive design for newly diagnosed multiple myeloma (NDMM) participants who have had prior induction therapy.
View original scientific description
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.
Interventions
DRUG
Elranatamab
Participants will receive step up dosing of Elranatamab subcutaneously in first cycle of consolidation followed by fixed dosing for 2 additional cycles and for 12 cycles in maintenance. Arm A participants will receive additional 12 cycles of Elranatamab monotherapy if they are MRD negative after Maintenance 1 for a total of 27 cycles. Cycles will be 28 days.
DRUG
Daratumumab
Participants will be given 1800 mg of Daratumumab subcutaneously every 4 weeks for up a maximum of 26 cycles.
DRUG
Lenalidomide
Participants will receive 10 mg of Lenalidomide daily by mouth for 21 days of each 28-day cycle for up to a maximum of 24 cycles.
PROCEDURE
autologous stem cell transplantation
Participants will undergo ASCT as standard treatment following individual site's processes and practices.
Primary outcome measures
Rate of MRD negativity after completion of Maintenance 1
Time frame: At 60 weeks
Rate of participants with MRD negativity (defined as \<10-5) after completion of the Maintenance 1 portion of the study.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age \>18 years with no upper age limit. 2. Newly diagnosed multiple myeloma with indication for initiation of therapy diagnosed within last 12 months. Pretreatment parameters necessary for disease characterization and response assessment must be available. 3. Eligible for ASCT according to institutional policy as evaluated by investigator. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix A). 5. Prior induction therapy including one PI, lenalidomide, and an anti-CD38 mAb for 16-24 weeks, obtaining at least a partial response (PR). 6. Measurable disease meeting at least 1 of the following criteria (at the time of diagnosis): a. Serum monoclonal (M) protein ≥1.0 g/dl (≥0.5 g/dl if IgA, IgD, IgE or IgM MM). b. ≥200 mg of M protein/24h in the urine. c. Difference between affected and unaffected free light chain ≥10 mg/dL with abnormal kappa to lambda ratio. 7. Have trackable clonogenic sequence using ClonoSEQ® (Seattle, WA) identi
Where
- Birmingham, Alabama
- Denver, Colorado
- Iowa City, Iowa
- Chapel Hill, North Carolina
- Cincinnati, Ohio
- Columbus, Ohio
- Nashville, Tennessee
- Dallas, Texas
- Norfolk, Virginia
- Madison, Wisconsin
- Milwaukee, Wisconsin
Collaborators
Pfizer, coMMit, Myeloma Trials, Innovated
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations