Phase I Study of Perifosine + Lenalidomide and Dexamethasone for Patients With Multiple Myeloma
NCT00415064 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2012-07-06
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 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.
Conditions
Interventions
- DRUG
-
Perifosine
Perifosine given in either 50 mg or 100 mg / day
- DRUG
-
Lenalidomide given in either 15 or 25 mg / day
- DRUG
-
Dexamethasone given in 20 mg / day
Sponsors & Collaborators
-
AEterna Zentaris
lead INDUSTRY
Principal Investigators
-
Andrzej J Jakubowiak, MD, PhD · University of Michigan
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-12-31
- Primary Completion
- 2012-07-31
- Completion
- 2012-07-31
Countries
- United States
Study Locations
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