Study on Isatuximab With or Without Lenalidomide for High Risk Smoldering Multiple Myeloma (ISAMAR)
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT02960555
This clinical trial is testing the effectiveness of the drug isatuximab, with or without lenalidomide, in patients with high risk smoldering multiple myeloma, a condition that can progress to multiple myeloma.
Patient Parameters
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Program Overview
This study aims to evaluate how well the drug isatuximab, alone or combined with lenalidomide, works in treating patients with high risk smoldering multiple myeloma. The study will look at how patients respond to the treatment, how long they remain free from disease progression, and overall survival rates. It will also assess the safety of the treatment and how the body reacts to isatuximab.
Description
The study is divided into two groups: one group will receive isatuximab alone, and the other group will receive isatuximab combined with lenalidomide. Isatuximab is given through an IV, starting with a longer infusion on the first day and shorter infusions on subsequent days. For those receiving lenalidomide, it is taken orally for 21 out of 28 days during the first six cycles. Each treatment cycle lasts 28 days, and patients can receive up to 30 cycles unless the disease progresses or side effects become unacceptable. After completing the treatment, patients will have follow-up visits every 6-12 months to monitor their health.
Eligibility Criteria
Inclusion Criteria
- Have high risk smoldering multiple myeloma, which is a condition that can progress to multiple myeloma.
- Meet specific criteria for high risk, such as a high percentage of abnormal plasma cells in the bone marrow or low levels of certain antibodies in the blood.
- Be 18 years or older.
- Have good kidney function and overall health, with specific blood counts and liver function within acceptable ranges.
- Women of childbearing potential and men with partners of childbearing potential must agree to use effective contraception during the study and for a period after the last dose of isatuximab.
- Be able to provide informed consent to participate in the study.
Exclusion Criteria
- Have evidence of multiple myeloma or certain biomarkers indicating a high risk of cancer progression.
- Have other serious health conditions, such as uncontrolled heart disease or active infections like hepatitis B, hepatitis C, or HIV.
- Be pregnant or breastfeeding.
- Have a history of severe allergic reactions to similar treatments.
- Have received certain treatments for smoldering multiple myeloma or other cancers.
- Have uncontrolled lung disease or have been hospitalized for lung issues in the past six months.
- Have had major surgery within the past month.
- Be unable to comply with study requirements due to other health or social issues.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mount Sinai Hospital | 10029 | New York | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| M D Anderson Cancer Center | 77030 | Houston | Texas |
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