Study on Isatuximab with Lenalidomide and Dexamethasone for High-Risk Smoldering Multiple Myeloma
Sponsor: Sanofi
ClinicalTrials ID:NCT04270409
This clinical trial is testing a new combination of drugs, including Isatuximab, Lenalidomide, and Dexamethasone, to see if they can help delay the progression of high-risk smoldering multiple myeloma, a condition that can lead to multiple myeloma.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to find out if adding Isatuximab to the standard treatment of Lenalidomide and Dexamethasone can help patients with high-risk smoldering multiple myeloma live longer without their disease getting worse. The trial will also look at how safe this combination is and how well it works in reducing cancer cells.
Description
This study will last about 12 years and includes different phases. Initially, there will be a 42-day screening period to determine eligibility, followed by up to 36 months of treatment, and then a follow-up period of about 9 years. The trial will first confirm the best dose of Isatuximab when used with Lenalidomide and Dexamethasone. Then, it will compare the effectiveness of this combination against the standard treatment without Isatuximab. Researchers will measure how long patients live without their disease progressing, the overall response to the treatment, and any side effects. They will also study how the treatment affects cancer cells and the immune system.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with high-risk smoldering multiple myeloma within the last 5 years.
- Good overall health with a performance status score of 0, 1, or 2.
- Able to provide written consent to participate.
- Meet specific blood count and liver function requirements.
- No signs of active multiple myeloma or related conditions.
Exclusion Criteria
- Have symptoms or conditions that indicate active multiple myeloma, such as high calcium levels, kidney problems, anemia, or bone lesions.
- Have other types of blood disorders or cancers.
- Have uncontrolled infections or significant heart or vascular diseases.
- Have active hepatitis or HIV infections.
- Have digestive issues that affect the absorption of Lenalidomide.
- Have had recent treatment for other cancers or certain medical conditions.
- Have used certain medications for smoldering multiple myeloma or multiple myeloma before.
- Are taking high doses of corticosteroids.
- Are not willing to use effective birth control methods if of childbearing potential.
- Have received a live vaccine within 4 weeks before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCLA Site Number : 8400010 | 90024 | Los Angeles | California |
| Colorado Blood Cancer Institute Site Number : 8400007 | 80218 | Denver | Colorado |
| Cancer Specialist of North Florida Site Number : 8400011 | 32256 | Jacksonville | Florida |
| University of Miami Site Number : 8400012 | 33136 | Miami | Florida |
| Dana Farber Cancer Institute Site Number : 8400001 | 02115 | Boston | Massachusetts |
| Presbyterian Hospital Site Number : 8400015 | 28204 | Charlotte | North Carolina |
| Novant Health Forsyth Medical Center Site Number : 8401015 | 27103 | Winston-Salem | North Carolina |
| Tennessee Oncology Site Number : 8400006 | 37203 | Nashville | Tennessee |
| ~University of Texas - MD Anderson Cancer Center Site Number : 8400002 | 77030 | Houston | Texas |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.