Quad Therapy for Multiple Myeloma
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot use certain strong medications like rifampin or St. John's wort within 14 days before starting the trial. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug combination used in the Quad Therapy for Multiple Myeloma?
Research shows that combining daratumumab with pomalidomide and dexamethasone improved progression-free survival in patients with previously treated multiple myeloma. Additionally, a study found that ixazomib with pomalidomide and dexamethasone had a 51.7% overall response rate in patients with resistant multiple myeloma, suggesting the potential effectiveness of these drugs in combination.12345
Is Quad Therapy for Multiple Myeloma safe for humans?
The combination of drugs used in Quad Therapy, including Ixazomib, Daratumumab, Pomalidomide, and Dexamethasone, has been studied in various trials for multiple myeloma. These studies show that while the treatment is generally well-tolerated, some patients may experience side effects like fatigue, infections, and blood-related issues (such as low blood cell counts).24678
What makes the Quad Therapy for Multiple Myeloma unique?
The Quad Therapy for Multiple Myeloma is unique because it combines four drugs—Daratumumab, Dexamethasone, Ixazomib, and Pomalidomide—each with different mechanisms to target the cancer cells, potentially improving treatment effectiveness compared to using fewer drugs. This combination aims to enhance progression-free survival and is particularly beneficial for patients who have already undergone other treatments.134910
What is the purpose of this trial?
The purpose of this study is to determine the overall response rate of patients with Multiple Myeloma to the combination of Daratumumab, Ixazomib, Pomalidomide and Dexamethasone.
Research Team
Caitlin Costello, MD
Principal Investigator
University of California, San Diego
Eligibility Criteria
This trial is for adults with Multiple Myeloma who've had 1-3 prior treatments but haven't used Daratumumab or Ixazomib before. They must not be pregnant, agree to birth control measures, and join the POMALYST REMS program. Participants should have a life expectancy over 3 months, an ECOG status of 0-2, and adequate organ function.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone as salvage therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for progression-free survival and overall survival
Treatment Details
Interventions
- Daratumumab
- Dexamethasone
- Ixazomib
- Pomalidomide
Daratumumab is already approved in European Union, United States for the following indications:
- Relapsed and refractory multiple myeloma
- Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
- Multiple myeloma in patients who have received at least three prior therapies
- Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
- Relapsed or refractory multiple myeloma in combination with lenalidomide and dexamethasone
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
Celgene
Industry Sponsor
Jay Backstrom
Celgene
Chief Medical Officer since 2016
MD
Mark Alles
Celgene
Chief Executive Officer since 2016
Bachelor's degree from Lock Haven University of Pennsylvania
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
Janssen, LP
Industry Sponsor
Joaquin Duato
Janssen, LP
Chief Executive Officer since 2022
MBA from ESADE Business School
Biljana Naumovic
Janssen, LP
Chief Medical Officer since 2023
MD from Belgrade University Medical School