Quad Regimen for Multiple Myeloma
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Participants receive 12 cycles of lenalidomide, ixazomib, daratumumab, and dexamethasone
Maintenance
Participants receive maintenance therapy with lenalidomide, with or without ixazomib and daratumumab, until disease progression or unacceptable toxicity, for up to 2 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Daratumumab Injection
- Dexamethasone
- Ixazomib
- Lenalidomide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance Foundation Trials, LLC.
Lead Sponsor
Janssen Scientific Affairs, LLC
Industry Sponsor
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
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
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