Multiple Myeloma
Phase II Study of Subcutaneous (SC) Bortezomib, Lenalidomide, and Dexamethasone for Relapsed and/or Refractory Multiple Myeloma, Followed by SC Bortezomib Maintenance
NCI-12-C-0169, NCT01647165
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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 multiple myeloma in accordance with the clinical diagnostic criteria set forth by the International Myeloma Working Group
- Relapsed from complete response following previous therapy
- Measurable disease defined as one or more of the following:
- Serum monoclonal protein ≥ 1 gm/dL
- Urine monoclonal protein of ≥ 200 mg/24 hours
- Measurable free light chains by free light chain assay of ≥ 10 mg/dL with abnormal kappa to lambda free light chain ratio
- Measurable bone disease, defined as ≥ 1 unidimensionally measurable lesion (longest diameter to be recorded) ≥ 20 mm with conventional techniques or ≥ 10 mm with spiral CT scan (for patients with lytic bone disease)
- ≥ 18 years of age
- ECOG 0–2
- Adequate organ and bone marrow function
- No significant cardiovascular disease (New York Heart Association Class III or IV cardiac disease)
- Able to swallow whole tablets
- Not pregnant or nursing
- No serious illness that would preclude study participation
Study Outline:
- Screening physical examination; blood and tumor samples; bone marrow biopsy and imaging studies to determine eligibility for the study
- Bortezomib is given by subcutaneous (SC) (under the skin) injection; lenalidomide and dexamethasone are tablets given by mouth
- Each course of study treatment lasts 21 days (1 cycle); cycles continue as long as the disease does not get worse and there are no serious side effects
- Up to eight 21-day cycles; following cycle eight, if the disease is stable or better, participants will receive bortezomib SC at the dose given at the end of cycle eight
- Participants will be monitored with blood samples, physical examinations, and tumor imaging studies 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.
Reviewed: 9/6/12
Updated: 7/25/12
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