Study on New Drug Combination for Transplant-Eligible Multiple Myeloma Patients
Sponsor: Massachusetts General Hospital
ClinicalTrials ID:NCT04430894
This clinical trial is testing a new combination of drugs for people with newly diagnosed multiple myeloma who are eligible for a stem cell transplant. The study involves the drugs Carfilzomib, Isatuximab, Lenalidomide, and Dexamethasone.
Patient Parameters
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Program Overview
This study is exploring a new treatment for people with newly diagnosed multiple myeloma who can have a stem cell transplant. The treatment combines four drugs: Carfilzomib, Isatuximab, Lenalidomide, and Dexamethasone. The study will see if this combination is effective in treating the disease. Participants will go through two phases: an induction phase where they receive the drugs for up to 8 cycles, and a maintenance phase where they continue treatment for up to two years or until the disease progresses or side effects become too severe. About 50 people will participate in this Phase II trial, which tests the safety and effectiveness of the drug combination.
Description
This study is testing a new combination of drugs for people with newly diagnosed multiple myeloma who are eligible for a stem cell transplant. The treatment includes Carfilzomib, Isatuximab, Lenalidomide, and Dexamethasone. Participants will first go through an induction phase, receiving the drugs for up to 8 cycles, each lasting 28 days. After 4 cycles, stem cells will be collected, and some participants may proceed to a stem cell transplant. In the maintenance phase, participants will continue treatment for up to two years or until the disease progresses or side effects become too severe. The study aims to determine if this combination is effective in treating multiple myeloma. Although the individual drugs are approved for certain uses, the combination is still considered experimental for newly diagnosed multiple myeloma.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have a confirmed diagnosis of multiple myeloma with specific criteria, including measurable disease.
- Must be newly diagnosed and eligible for high-dose chemotherapy with a stem cell transplant.
- Must have a performance status score of 0, 1, or 2, indicating good overall health.
- Must have certain blood and organ function levels within specified limits.
- Women of childbearing potential must use two forms of birth control or abstain from heterosexual intercourse.
- Men must use a condom during sexual activity and not donate sperm during the study and for a specified period after.
- Must have two negative pregnancy tests before starting treatment if applicable.
- Must sign an informed consent form and be willing to follow study procedures.
Exclusion Criteria
- Cannot have certain other blood disorders or conditions like primary amyloidosis or smoldering multiple myeloma.
- Cannot have had previous treatments for multiple myeloma, except for a short course of steroids.
- Cannot have had another cancer within the past 5 years, with some exceptions.
- Cannot have had recent radiation therapy or plasmapheresis.
- Cannot have certain lung conditions or active infections like HIV or hepatitis.
- Cannot have significant heart disease or uncontrolled high blood pressure.
- Cannot have allergies to the study drugs or their components.
- Cannot be pregnant or breastfeeding, or planning to become pregnant or father a child during the study.
- Cannot have had major surgery recently or be planning surgery during the study.
- Cannot be taking certain medications that might interfere with the study drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Massachusetts General Hospital | 02115 | Boston | Massachusetts |
| Beth Israel Deaconess Medical Center | 02215 | Boston | Massachusetts |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
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