Quad Regimen for Multiple Myeloma

Recruiting at12 trial locations

Overseen by Evanthia Galanis, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Alliance Foundation Trials, LLC.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

A randomized Phase II clinical trial will be conducted to assess the impact on progression free survival (PFS) with the addition of ixazomib and daratumumab to lenalidomide as a maintenance treatment following induction with lenalidomide, ixazomib, dexamethasone, and daratumumab. Patients will be randomized to either: Arm A: 12 cycles of lenalidomide, ixazomib, daratumumab, and dexamethasone followed by lenalidomide until disease progression or unacceptable toxicity or a maximum of 2 years of maintenance therapy. Arm B: 12 cycles of lenalidomide, ixazomib, daratumumab and dexamethasone, followed by lenalidomide, ixazomib, and daratumumab until disease progression or unacceptable toxicity or a maximum of 2 years maintenance therapy.

Research Team

Evanthia Galanis, MD

Principal Investigator

Alliance Foundation Trials, LLC.

Andrew Yee, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults over 18 with newly diagnosed Multiple Myeloma who can't have a stem cell transplant. They must not be pregnant, planning to become pregnant, or breastfeeding and agree to use two birth control methods if applicable. Participants need an ECOG score of 0-2 and meet specific health criteria without severe allergies or recent treatments that could interfere.

Inclusion Criteria

I have confirmed multiple myeloma with specific test results.

I am using two reliable birth control methods or abstaining from sex.

I agree to follow the pregnancy testing schedule as required.

Exclusion Criteria

I have not used any experimental drugs or devices recently.

I have COPD or asthma.

Pregnant, breast-feeding, planning to become pregnant, or planning to father a child during the study period

Treatment Details

Interventions

• Daratumumab Injection (Monoclonal Antibodies)
• Dexamethasone (Corticosteroid)
• Ixazomib (Proteasome Inhibitor)
• Lenalidomide (Immunomodulatory Agent)

Trial Overview The study tests whether adding ixazomib and daratumumab to lenalidomide maintenance therapy after initial treatment with these drugs plus dexamethasone improves patient outcomes. It's randomized: one group gets the full combo followed by just lenalidomide; the other continues all three drugs as maintenance.

Participant Groups

Group I: Lenalidomide, Ixazomib, Daratumumab, and Dexamethasone Experimental Treatment 4 Interventions

12 cycles of lenalidomide, ixazomib, dexamethasone, and daratumumab followed by lenalidomide, ixazomib, and daratumumab until disease progression or unacceptable toxicity or a maximum of 2 year maintenance therapy.

Group II: Lenalidomide Experimental Treatment 4 Interventions

12 cycles of lenalidomide, ixazomib, daratumumab, and dexamethasone followed by lenalidomide until disease progression or unacceptable toxicity or a maximum of 2 years of maintenance therapy.

Who Is Running the Clinical Trial?

Alliance Foundation Trials, LLC.

Lead Sponsor

Trials

25

Recruited

27,200+

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials

165

Recruited

579,000+

Ricardo Attar

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology, University of Buenos Aires

Dr. Anastasia G. Daifotis

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2023

MD

Takeda

Industry Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Celgene Corporation

Industry Sponsor

Trials

446

Recruited

58,500+

Mark Alles

Celgene Corporation

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Sol J. Barer

Celgene Corporation

Chief Medical Officer since 2006

PhD in Organic and Physical Chemistry from Rutgers University