T-cell Engager vs Stem Cell Transplant for Multiple Myeloma

(FASTER Trial)

Recruiting at 2 trial locations

Overseen By Sarah Cannon Development Innovations, LLC

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: SCRI Development Innovations, LLC

Must be taking: Lenalidomide, Anti-CD38 mAb

Must not be taking: Anti-BCMA, Epigenetic therapy

Disqualifiers: CNS involvement, Active malignancies, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

Henning Schade, MD

Principal Investigator

Colorado Blood Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults with newly diagnosed multiple myeloma who've had prior therapy and responded partially. They must have measurable disease, be fit (ECOG 0-1), able to undergo stem cell transplant, and not need recent blood transfusions. It's not suitable for those outside these criteria or ineligible by institutional policy.

Inclusion Criteria

I've had initial treatment with specific drugs and saw improvement.

My cancer can be measured by medical tests.

My cancer has a trackable genetic marker for monitoring.

Exclusion Criteria

Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients

Minimum washout periods for prior therapy

I do not have myelodysplastic syndrome or other active cancers, except for MM.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Consolidation

Participants receive either elranatamab and daratumumab or undergo ASCT followed by lenalidomide and daratumumab

12 weeks

Weekly visits for elranatamab and daratumumab; ASCT according to standard of care

Maintenance 1

Participants receive maintenance treatment with either elranatamab and daratumumab or lenalidomide and daratumumab

48 weeks

Monthly visits

Maintenance 2

Participants with MRD negativity continue with monotherapy maintenance treatment

48 weeks

Monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Stem Cell Transplantation
• Daratumumab
• Elranatamab
• Lenalidomide

Trial Overview The study compares two treatments post-induction: Arm A uses elranatamab plus daratumumab as consolidation/maintenance, while Arm B involves a stem cell transplant followed by lenalidomide and daratumumab treatment. The goal is to see which method better eliminates residual disease in the bone marrow.

How Is the Trial Designed?

Group I: Arm B1 (Late Intensification) Experimental Treatment 2 Interventions

Participants randomized to Arm B that have MRD positivity after Maintenance 1 will receive Elranatamab in combination with Daratumumab for three 28-day cycles as consolidation, followed by Elranatamab in combination with Daratumumab for additional twelve 28-day cycles of maintenance treatment in the Late Intensification portion of the study.

Group II: Arm A1 (Late Intensification) Experimental Treatment 3 Interventions

Participants randomized to Arm A that have MRD positivity after Maintenance 1 will undergo ASCT according to standard of care institutional practices followed by twelve 28-day cycles of maintenance treatment with Lenalidomide and Daratumumab in the Late Intensification portion of the study.

Group III: Arm A (Elranatamab + Daratumumab) Experimental Treatment 2 Interventions

Participants will receive step up dosing of Elranatamab subcutaneously in first cycle followed by weekly dosing for the remainder of the cycle 1. In cycle 2 and 3, elranatamab will be administered every two weeks (Consolidation portion). This will be followed by elranatamab every 4 weeks for 12 cycles in the Maintenance 1 portion. Daratumumab will be given subcutaneously at a fixed dose every 4 weeks starting at Cycle 2 and 3 of Consolidation and for 12 cycles in the Maintenance 1 portion of the study. After completion of Maintenance 1, participants with MRD negativity will receive Elranatamab monotherapy every 4 weeks for additional 12 cycles in Maintenance 2 portion. Participants with MRD positivity will proceed to Arm A1. Participants will undergo therapy in the assigned arm until disease progression, permanent discontinuation (irrespective of reason), death or completion of planned therapy. Cycles will be 28 days. Consolidation consists of 3 cycles; Maintenance 1 consists of 12

Group IV: Arm B (ASCT + lenalidomide/daratumumab) Active Control 3 Interventions

Participants will undergo ASCT according to standard of care institutional practices in the Consolidation portion of the study followed by twelve 28-day cycles of Lenalidomide and Daratumumab in the Maintenance 1 portion. After completion of Maintenance 1, participants with MRD negativity will receive Lenalidomide monotherapy for additional 12 cycles in Maintenance 2 portion. Participants with MRD positivity will proceed to Arm B1. Participants will undergo therapy in the assigned arm until disease progression, permanent discontinuation (irrespective of reason), death or completion of planned therapy. Cycles will be 28 days. Consolidation consists of ASCT; Maintenance 1 consists of 12 cycles; Maintenance 2 consists of 12 cycles. Up to 50 participants will be enrolled to this arm.

Who Is Running the Clinical Trial?

SCRI Development Innovations, LLC

Lead Sponsor

Trials

193

Recruited

13,800+

coMMit, Myeloma Trials, Innovated

Collaborator

Trials

2

Recruited

380+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University