Status:
COMPLETED
Phase I Study of Perifosine + Lenalidomide and Dexamethasone for Patients With Multiple Myeloma
Lead Sponsor:
AEterna Zentaris
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 relap...
Detailed Description
This is a phase I study of perifosine in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma. All patients will receive lenalidomide daily for day...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00415064
Start Date
December 1 2006
End Date
July 1 2012
Last Update
July 6 2012
Active Locations (1)
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1
Ann Arbor, Michigan, United States, 48109