Study on Lenalidomide for Treating Multiple Myeloma in Patients Undergoing Stem Cell Transplant
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT00114101
This clinical trial is testing whether the drug lenalidomide is more effective than a placebo in helping patients with multiple myeloma who are receiving a stem cell transplant. The study aims to see if lenalidomide can help prevent the cancer from coming back after the transplant.
Patient Parameters
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Program Overview
This study is exploring the effectiveness of lenalidomide compared to a placebo in patients with multiple myeloma who are undergoing a stem cell transplant. The process involves using chemotherapy to kill cancer cells and make space in the bone marrow for new stem cells. After collecting and storing stem cells from the patient's blood, more chemotherapy is given to prepare for the transplant. The stem cells are then returned to the patient to replace those destroyed by chemotherapy. Lenalidomide, a biological therapy, may help stop cancer cells from growing by affecting the immune system. The study will determine if taking lenalidomide after the transplant is an effective treatment for multiple myeloma.
Description
The main goal of this study is to find out if lenalidomide can help delay the return of multiple myeloma after a stem cell transplant. Researchers also want to see if lenalidomide can increase the number of patients who achieve a complete response, meaning no signs of cancer are found after treatment. The study will compare how long patients live without the cancer getting worse and overall survival between those taking lenalidomide and those taking a placebo. Additionally, the study will assess if long-term use of lenalidomide is feasible for patients.
The study involves several steps:
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Stem Cell Collection: Patients will have their stem cells collected from their blood according to standard procedures.
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Stem Cell Transplant: Patients will receive chemotherapy with melphalan to prepare for the transplant. The collected stem cells will then be returned to the patient.
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Maintenance Treatment: Patients will be randomly assigned to receive either lenalidomide or a placebo starting about 100-110 days after the transplant. Treatment will continue as long as it is effective and does not cause unacceptable side effects.
After completing the study treatment, patients will have follow-up visits every three months for the first year and then every six months.
Eligibility Criteria
Inclusion Criteria
- Must have active multiple myeloma that requires treatment and is stable or responding to at least two months of initial therapy.
- No more than 12 months of prior therapy, including lenalidomide and thalidomide.
- Must be within 12 months of starting initial therapy.
- No previous progression after initial therapy and no more than two treatment regimens, excluding dexamethasone alone.
- No prior stem cell or organ transplants.
- Must have collected enough stem cells from the blood before the transplant.
- Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Must have adequate lung and heart function as determined by specific tests.
- Must not have uncontrolled diabetes or active serious infections.
- Must not be positive for HIV, hepatitis B, or hepatitis C.
- Women must not be pregnant or nursing and must use effective birth control if of childbearing potential.
- Men must agree to use condoms during sexual contact with women of childbearing potential while taking lenalidomide and for four weeks after stopping.
- Must have adequate blood counts and kidney function as determined by specific tests.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic in Arizona | 85259 | Scottsdale | Arizona |
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| UC San Diego Medical Center - Hillcrest | 92103 | San Diego | California |
| UCSF Medical Center-Mount Zion | 94115 | San Francisco | California |
| The Medical Center of Aurora | 80012 | Aurora | Colorado |
| Boulder Community Foothills Hospital | 80303 | Boulder | Colorado |
| Penrose-Saint Francis Healthcare | 80907 | Colorado Springs | Colorado |
| AdventHealth Porter | 80210 | Denver | Colorado |
| Presbyterian - Saint Lukes Medical Center - Health One | 80218 | Denver | Colorado |
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