Ixazomib + Lenalidomide + Dexamethasone for Smoldering Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, ixazomib, combined with lenalidomide and dexamethasone, to treat smoldering multiple myeloma, a type of blood cancer not yet causing symptoms. The goal is to determine if this combination can slow or stop disease progression. It targets individuals diagnosed with high-risk smoldering multiple myeloma, indicating a higher likelihood of developing active multiple myeloma. Participants should exhibit specific disease-related characteristics, such as certain protein levels in their blood, but should not have symptoms like bone pain or kidney issues from active multiple myeloma. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in treatment.
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 take certain medications like strong CYP3A inducers (e.g., rifampin, carbamazepine) or supplements like Ginkgo biloba and St. John's wort within 14 days before starting the trial. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found the combination of ixazomib, lenalidomide, and dexamethasone to be effective and generally safe for patients, indicating that the treatment worked well and most patients tolerated it without serious issues. Another study showed that lenalidomide did not lower patients' quality of life, which is encouraging.
While all medications can have side effects, research suggests that these drugs, when used together, are manageable for patients with smoldering multiple myeloma. This information may reassure those considering joining a clinical trial with this combination.12345Why do researchers think this study treatment might be promising for Smoldering Multiple Myeloma?
Researchers are excited about the combination of Ixazomib, Lenalidomide, and Dexamethasone for smoldering multiple myeloma because it offers a unique approach compared to standard treatments. Unlike traditional therapies, which often focus on one or two drugs, this combination leverages the synergistic effects of three different agents. Ixazomib, in particular, is a proteasome inhibitor taken orally, potentially offering a more convenient administration method than injections or infusions required by similar drugs. Additionally, this combination targets multiple pathways involved in the progression of multiple myeloma, which could lead to more effective disease control.
What evidence suggests that this trial's treatments could be effective for Smoldering Multiple Myeloma?
Research has shown that the combination of ixazomib, lenalidomide, and dexamethasone, which participants in this trial will receive, effectively treats smoldering multiple myeloma, particularly in high-risk patients. Studies have found that this treatment can delay the progression to active multiple myeloma and extend patient survival. In one study, patients receiving this combination experienced longer periods without disease progression. Better responses to the treatment correlated with improved long-term outcomes. Overall, this combination appears promising for slowing the disease and providing patients with more healthy time.23467
Who Is on the Research Team?
Irene Ghobrial, MD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for adults with high-risk Smoldering Multiple Myeloma who can sign consent, are not pregnant, agree to birth control measures, and have no active major illnesses. Excluded are those with recent surgeries or other treatments, certain infections (HIV/HBV/HCV), another cancer within 2 years (with exceptions), known allergies to similar drugs, or any previous ixazomib treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Ixazomib, Lenalidomide, and Dexamethasone in cycles. Cycles 1-9 involve Ixazomib on days 1, 8, 15; Lenalidomide on days 1-21; Dexamethasone on days 1, 8, 15, 22. Cycles 10-24 involve Ixazomib on days 1, 8, 15 and Lenalidomide on days 1-21.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
- Ixazomib
- Lenalidomide
Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Immune system disorders
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
- Neoplastic diseases
- Nervous system disorders
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
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