Quad Regimen for Multiple Myeloma

Recruiting at 12 trial locations

Overseen By Quality Management and Compliance

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Alliance Foundation Trials, LLC.

Must be taking: Lenalidomide, Ixazomib, Daratumumab

Must not be taking: Strong CYP3A inducers

Disqualifiers: AL amyloidosis, Waldenström's, 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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

79 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Evanthia Galanis, MD

Principal Investigator

Alliance Foundation Trials, LLC.

Andrew Yee, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive 12 cycles of lenalidomide, ixazomib, daratumumab, and dexamethasone

48 weeks

Weekly visits for drug administration

Maintenance

Participants receive maintenance therapy with lenalidomide, with or without ixazomib and daratumumab, until disease progression or unacceptable toxicity, for up to 2 years

Up to 2 years

Monthly visits for drug administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Daratumumab Injection
• Dexamethasone
• Ixazomib
• Lenalidomide

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.

How Is the Trial Designed?

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+

Joaquin Duato

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

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