Isa-Rd Combo Therapy for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination treatment for individuals recently diagnosed with multiple myeloma, a type of blood cancer. The study examines whether lower doses of three drugs—isatuximab (an antibody therapy), lenalidomide, and dexamethasone—remain effective while reducing side effects. It targets individuals who may not tolerate standard, more intense treatments due to concerns about severe side effects. Those with measurable multiple myeloma who have not received more than 28 days of prior treatment might be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to significant findings.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, if you are on medications that are prohibited by the study, you may need to discontinue or replace them with alternatives.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that combining isatuximab, lenalidomide, and dexamethasone has been used in other studies for treating multiple myeloma. These studies indicate that the combination is generally safe, but it can have some serious side effects. For example, isatuximab can sometimes cause severe infections, so healthcare providers monitor patients closely for this.
Lenalidomide and dexamethasone also have their own side effects. Lenalidomide can cause issues with blood, like low white blood cell counts, which can increase the risk of infections. Dexamethasone, a type of steroid, might lead to higher blood sugar levels or mood changes.
The current trial uses lower doses of these drugs to try to reduce side effects. While this combination of drugs hasn't been approved by the FDA for new cases of multiple myeloma at these doses, earlier studies have shown that such combinations are generally well-tolerated. Always discuss any concerns with your healthcare provider.12345Why do researchers think this study treatment might be promising for multiple myeloma?
Researchers are excited about the combination of isatuximab, lenalidomide, and dexamethasone for treating multiple myeloma because it offers a novel approach compared to standard treatments. Isatuximab is a monoclonal antibody that specifically targets the CD38 protein on myeloma cells, which is different from traditional therapies that may not target this protein as directly. This targeted action can potentially enhance the effectiveness of treatment by directly attacking cancer cells while sparing more healthy cells. Additionally, combining isatuximab with lenalidomide and dexamethasone may create a synergistic effect, improving patient outcomes more than using these drugs individually.
What evidence suggests that this combination therapy could be effective for multiple myeloma?
Research has shown that combining isatuximab with lenalidomide and dexamethasone is promising for treating multiple myeloma, a type of blood cancer. Studies have found that adding isatuximab to these treatments helps patients live longer without their disease worsening. Specifically, patients receiving this combination experienced longer periods without cancer progression compared to those who did not receive isatuximab. This suggests that isatuximab can enhance the effectiveness of these existing medicines. The trial will administer the combination of isatuximab, lenalidomide, and dexamethasone to all participants, using lower doses to minimize side effects, with the aim of replicating the combination's success seen in other studies for newly diagnosed patients.36789
Who Is on the Research Team?
Sascha Tuchman, MD
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for older or frail patients with newly diagnosed multiple myeloma who haven't had more than 28 days of anti-myeloma therapy. They must be at high risk for severe side effects from standard treatments, have measurable MM and related organ dysfunction, and show adequate organ function. Women of childbearing age must use birth control.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive isatuximab, lenalidomide, and dexamethasone with 28-day cycles. Isatuximab is administered for two years, dexamethasone weekly for the first eight cycles, and lenalidomide continued as maintenance until disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment until death or full withdrawal from the study. Those withdrawn for adverse events are followed for resolution or stabilization of the adverse event(s).
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
- Isatuximab
- 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?
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
Genzyme, a Sanofi Company
Industry Sponsor
David Meeker
Genzyme, a Sanofi Company
Chief Executive Officer since 2011
MD from the University of Vermont Medical School, Advanced Management Program at Harvard Business School
Jean-Paul Kress
Genzyme, a Sanofi Company
Chief Medical Officer since 2015
MD from Faculte Necker-Enfants Malades, Paris