Study on Isatuximab with Bortezomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma Patients Not Eligible for Transplant
Sponsor: Sanofi
ClinicalTrials ID:NCT03319667
This clinical trial is testing whether adding isatuximab to a standard treatment can help improve outcomes for adults with newly diagnosed multiple myeloma who cannot undergo a transplant.
Patient Parameters
| Parameter | Options |
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Program Overview
The main goal of this study is to see if adding isatuximab to the standard treatment of bortezomib, lenalidomide, and dexamethasone can help patients with newly diagnosed multiple myeloma live longer without their disease getting worse. The study will also look at other outcomes, such as how many patients have a complete response, how long patients live overall, and the safety of the treatment. Researchers will also study the quality of life and how the body processes the drug.
Description
Participants in this study will go through several phases. First, there is a screening period of up to 4 weeks to determine eligibility. Then, there is an induction period lasting 24 weeks, where participants receive treatment in cycles of about 42 days each. After that, there is a continuous treatment period, and for some, a crossover period where they might switch treatments. During the continuous and crossover periods, treatment cycles last about 28 days. The study aims to find out if the addition of isatuximab can improve treatment outcomes for patients with multiple myeloma who are not eligible for a transplant.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with multiple myeloma.
- Newly diagnosed and not eligible for a transplant due to being 65 years or older, or younger than 65 with other health issues.
- Have measurable disease.
- Able to provide written informed consent.
Exclusion Criteria
- Under 18 years old.
- Have received prior treatment for multiple myeloma.
- Have other health conditions that conflict with the study.
- Do not meet required organ function levels.
- Have a performance status score greater than 2, indicating more severe disability.
- Allergic to the study medications.
- Pregnant, breastfeeding, or unwilling to use contraception if of childbearing potential.
- Male participants unwilling to follow contraceptive guidance.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Investigational Site Number: 8400006 | 33901 | Fort Myers | Florida |
| Investigational Site Number: 8400004 | 33705 | St. Petersburg | Florida |
| Investigational Site Number: 8400007 | 64132 | Kansas City | Missouri |
| Investigational Site Number: 8400005 | 37203 | Nashville | Tennessee |
| Investigational Site Number: 8400001 | 77030 | Houston | Texas |
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