Phase I Study of Perifosine + Lenalidomide and Dexamethasone for Patients With Multiple Myeloma
Completed · Phase 1
Conditions studied: Multiple Myeloma
In brief
This is a phase I study of perifosine in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma. The current protocol will enroll patients with relapsed or refractory multiple myeloma requiring second or third line therapy. Six patients each will be treated with at one of 4 dose levels in a phase 1 study. All patients will receive perifosine, lenalidomide and dexamethasone of each 28 day cycle. The doses of perifosine and lenalidomide will be varied in each group. The dose of dexamethasone will remain constant.
Key facts
- Study ID
- NCT00415064
- Run by
- AEterna Zentaris
- People needed
- 32
- Starts
- 2006-12-01
- Expected to finish
- 2012-07-01
- Last updated by the study team
- 2012-07-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject was previously diagnosed with multiple myeloma based on standard diagnostic criteria, as follows.
- Major criteria:
- Plasmacytomas on tissue biopsy.
- Bone marrow plasmacytosis (> 30% plasma cells).
- Monoclonal immunoglobulin spike on serum electrophoresis immunoglobulin G (IgG) >3.5 g/dL or immunoglobulin A (IgA) > 2.0 g/dL; kappa or lambda light chain excretion > 1 g/day on 24 hour urine protein electrophoresis.
- Patients must have relapsed or refractory disease (refractory is defined as progression during treatment or within 60 days after the completion of treatment) requiring 2nd or 3rd line therapy
- Patients refractory to a combination of lenalidomide and dexamethasone will not be eligible. Patients may have received lenalidomide and/or dexamethasone
You may not qualify if…
- Renal insufficiency (serum creatinine levels > 3 mg/dL)..
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
- Known hypersensitivity to thalidomide
Where it is running
- Study site — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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