Multiple Myeloma
Lenalidomide Maintenance Therapy in Multiple Myeloma: A Phase II Clinical and Biomarker Study
NCI-12-C-0192 , NCT01675141
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Investigator(s): |
C. Ola Landgren, M.D., Ph.D. Principal Investigator Phone: 301-496-0670 Fax: 301-402-0172 landgreo@mail.nih.gov
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Marcia L. Mulquin, R.N., B.S.N. Research Nurse Phone: 301-435-5613 mmulquin@mail.nih.gov
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Diamond Zuchlinski, R.N., B.S.N., O.C.N. Research Nurse Phone: 301-435-9227 zuchlinskid@mail.nih.gov
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Key Eligibility Criteria:
- Histologically confirmed diagnosis of multiple myeloma:
- Participants who have been treated with induction therapy or re-induction therapy, who at the time of study enrollment have documented evidence of stable disease response or better according to the International Myeloma Workshop Consensus Panel
- The response assessment must occur at least 4 weeks after completion of their last treatment
- ≥ 18 years of age
- ECOG 0–2
- Adequate hematologic, renal, hepatic, and cardiac function
- No significant cardiovascular disease (New York Heart Association Class III or IV cardiac disease)
- Able to swallow whole tablets
- Not pregnant or nursing
- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin)
- No serious illness that would preclude study participation
Study Outline:
- Screening physical examination; blood samples; and imaging studies to determine eligibility for the study
- Qualified participants will receive lenalidomide maintenance treatment, given according to the standard of care for multiple myeloma
- Maintenance treatment continues as long as the disease does not get worse and there are no serious side effects
- Participants will be monitored with blood samples (to assess T cell, NKT, and NK cell numbers), and physical examinations through the cycles of treatment
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed:
Updated: 11/14/12