Multiple Myeloma Clinical Trial
Official title:
An Open-Label Phase I Study of the Safety of Perifosine in Combination With Lenalidomide and Dexamethasone for Patients With Relapsed or Refractory Multiple Myeloma
Verified date | November 2011 |
Source | AEterna Zentaris |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subject was previously diagnosed with multiple myeloma based on standard diagnostic criteria, as follows. - Major criteria: 1. Plasmacytomas on tissue biopsy. 2. Bone marrow plasmacytosis (> 30% plasma cells). 3. 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 Criteria: - 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
AEterna Zentaris |
United States,
Jakubowiak AJ, Richardson PG, Zimmerman T, Alsina M, Kaufman JL, Kandarpa M, Kraftson S, Ross CW, Harvey C, Hideshima T, Sportelli P, Poradosu E, Gardner L, Giusti K, Anderson KC. Perifosine plus lenalidomide and dexamethasone in relapsed and relapsed/ref — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse Events | Every cycle | Yes | |
Secondary | Clinically significant changes in the patient's physical examination, vital signs, and clinical laboratory results | Every 12 weeks | No |
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