Study Comparing Lenalidomide, Bortezomib, and Dexamethasone with or without Stem Cell Transplant in Multiple Myeloma Patients up to Age 65
Sponsor: Paul Richardson, MD
ClinicalTrials ID:NCT01208662
This clinical trial is exploring whether a combination of drugs, with or without a stem cell transplant, is more effective in treating newly diagnosed multiple myeloma in patients up to 65 years old. The study aims to see if high-dose therapy is still necessary for initial treatment.
Patient Parameters
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Program Overview
The purpose of this study is to find out if a combination of drugs—lenalidomide, bortezomib, and dexamethasone—works better alone or when combined with a stem cell transplant for treating newly diagnosed multiple myeloma in younger patients. Researchers want to see if high-dose therapy is still needed in the era of new drugs. The study will compare how long patients live without the disease getting worse, aiming for at least a 9-month improvement in progression-free survival with high-dose therapy.
Description
This study involves using a combination of drugs, lenalidomide, bortezomib, and dexamethasone, which are approved by the FDA for treating multiple myeloma, but not in this specific combination. Bortezomib is approved for multiple myeloma, and lenalidomide is approved for use with dexamethasone in patients who have had prior treatment. Dexamethasone is commonly used for multiple myeloma. In this trial, these drugs are provided at no cost to participants.
The study also involves using melphalan and cyclophosphamide during stem cell collection and transplant. These drugs are approved for multiple myeloma and have been used in other studies, suggesting they may help treat newly diagnosed multiple myeloma.
Participants will be randomly assigned to one of two groups: one group will receive lenalidomide, bortezomib, and dexamethasone without a stem cell transplant, followed by lenalidomide maintenance (Arm A). The other group will receive the same drugs with a stem cell transplant, followed by lenalidomide maintenance (Arm B). There is an equal chance of being placed in either group. The assignment is based on the stage of the disease and specific genetic factors assessed during screening.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with Multiple Myeloma according to specific criteria.
- Have symptoms and organ damage related to myeloma, confirmed by lab tests within 21 days before joining the study.
- Myeloma must be measurable by blood or urine tests.
- Be in relatively good health with an ECOG performance status of 0 to 2.
- Test negative for HIV.
- Provide written informed consent to participate.
Exclusion Criteria
- Women who are pregnant or breastfeeding.
- Have had prior systemic therapy for multiple myeloma (except for certain conditions like localized radiotherapy or low-dose corticosteroids).
- Have primary amyloidosis or myeloma complicated by amyloidosis.
- Are receiving other investigational treatments.
- Have known brain metastases.
- Have allergies or poor tolerance to any study drugs.
- Have low blood counts or poor liver or kidney function as specified by lab tests.
- Have severe heart or lung conditions.
- Have active infections or other serious health issues.
- Have had another cancer, except for certain skin or cervical cancers, unless cured over two years ago.
- Cannot comply with anti-blood clot treatment.
- Have significant nerve damage (Grade 2 or higher).
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham | 35294 | Birmingham | Alabama |
| Arizona Comprehensive Cancer Center | 85724 | Tucson | Arizona |
| City of Hope | 91010 | Duarte | California |
| University of California at San Diego | La Jolla | California | |
| University of California, San Francisco | 94143 | San Francisco | California |
| Stanford University | 94305 | Stanford | California |
| Colorado Blood Cancer Institute | 80218 | Denver | Colorado |
| University of Florida | 32608 | Gainesville | Florida |
| H. Lee Moffitt Cancer Center | 33612 | Tampa | Florida |
| Emory University | 30322 | Atlanta | Georgia |
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