Bortezomib + Lenalidomide + Dexamethasone for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a combination of three drugs—lenalidomide, bortezomib, and dexamethasone—as a potential treatment for multiple myeloma, a cancer affecting plasma cells in the bone marrow. Researchers aim to determine if this drug combination can effectively manage the symptoms and progression of the condition. Individuals diagnosed with multiple myeloma who have not received other treatments may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to important findings.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot take certain corticosteroids and other specific medications. It's best to discuss your current medications with the trial team to see if they are allowed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of bortezomib, lenalidomide, and dexamethasone is generally well-tolerated by patients with multiple myeloma. In one study, no deaths related to the treatment occurred, which is reassuring. Some side effects, such as blood clots, were rare, occurring in only 6% of cases.
Patients responded well to this treatment, with all participants in the study showing at least some improvement. This suggests that while side effects may occur, they are manageable, and the treatment is effective for many people.
This treatment is currently being tested in a middle stage of clinical trials, indicating it has already demonstrated some safety in humans. Those considering joining a trial should discuss potential risks and benefits with their healthcare provider.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Bortezomib, Lenalidomide, and Dexamethasone for treating multiple myeloma because this combination offers a multi-faceted approach that could improve effectiveness. Unlike standard treatments that might use these drugs separately or in different sequences, this regimen combines them into a single protocol, potentially enhancing their synergistic effects. Bortezomib is administered subcutaneously, which may improve patient comfort and reduce side effects compared to intravenous options. Additionally, the regimen includes a personalized maintenance phase based on individual risk, which could lead to better long-term outcomes for patients.
What evidence suggests that this trial's treatments could be effective for multiple myeloma?
Studies have shown that a treatment combining lenalidomide, bortezomib, and dexamethasone (often called RVD) works well for people newly diagnosed with multiple myeloma. Participants in this trial will receive this combination treatment. Research indicates that RVD can significantly improve patient response to treatment and extend survival. This approach has become a common method for managing this type of cancer, helping patients live longer and slow the disease's progression. These findings make RVD a promising choice for those considering treatment for multiple myeloma.23467
Who Is on the Research Team?
Jacob Laubach, MD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for adults with newly diagnosed multiple myeloma who haven't had systemic therapy yet. They must have certain levels of monoclonal protein, organ dysfunction related to myeloma, and be able to follow the study plan. Women must test negative for pregnancy and use birth control; men should also use contraception if with a female partner of childbearing potential.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Participants receive lenalidomide, subcutaneous bortezomib, and dexamethasone for 4 to 8 cycles. Stem cell mobilization occurs at the end of Cycle 4.
Maintenance
High-risk participants receive subcutaneous bortezomib and lenalidomide, while standard-risk participants receive lenalidomide monotherapy.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bortezomib
- Dexamethasone
- Lenalidomide
Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:
- Multiple myeloma
- Mantle cell lymphoma
- Multiple myeloma
- Mantle cell lymphoma
- Multiple myeloma
- Mantle cell lymphoma
- Multiple myeloma
- Mantle cell lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Industry Sponsor
Dr. Christophe Bianchi
Millennium Pharmaceuticals, Inc.
Chief Medical Officer since 2006
MD from University of Geneva
Dr. Deborah Dunsire
Millennium Pharmaceuticals, Inc.
Chief Executive Officer since 2005
MD from University of Witwatersrand
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