Phase I Study of Perifosine + Lenalidomide and Dexamethasone for Patients With Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Perifosine
Lenalidomide
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Perifosine, Lenalidomide, Dexamethasone
Eligibility Criteria
Inclusion Criteria:
- 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 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
Sites / Locations
Outcomes
Primary Outcome Measures
Adverse Events
Secondary Outcome Measures
Clinically significant changes in the patient's physical examination, vital signs, and clinical laboratory results
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00415064
Brief Title
Phase I Study of Perifosine + Lenalidomide and Dexamethasone for Patients With Multiple Myeloma
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AEterna Zentaris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
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 days 1 to 21 of each 28 day cycle. Perifosine will be given daily qhs with food. Dexamethasone will be given on days 1-4, 9-12 and 17-20 for 4 cycles. After 4 cycles dexamethasone will be given only on days 1-4. Four dose levels will be studied:
Perifosine 50 mg, lenalidomide 15 mg and dexamethasone 20 mg
Perifosine 50 mg, lenalidomide 25 mg and dexamethasone 20 mg
Perifosine 100 mg, lenalidomide 15 mg and dexamethasone 20 mg
Perifosine 100 mg, lenalidomide 25 mg and dexamethasone 20 mg
Six patients will be enrolled at each dose level until the maximum tolerated dose (MTD) is reached. Six additional patients will be treated at the MTD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Perifosine, Lenalidomide, Dexamethasone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Perifosine
Intervention Description
Perifosine given in either 50 mg or 100 mg / day
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Lenalidomide given in either 15 or 25 mg / day
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone given in 20 mg / day
Primary Outcome Measure Information:
Title
Adverse Events
Time Frame
Every cycle
Secondary Outcome Measure Information:
Title
Clinically significant changes in the patient's physical examination, vital signs, and clinical laboratory results
Time Frame
Every 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrzej J Jakubowiak, MD, PhD
Organizational Affiliation
University of Michigan
Official's Role
Study Chair
Facility Information:
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22640031
Citation
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/refractory multiple myeloma: a Phase I Multiple Myeloma Research Consortium study. Br J Haematol. 2012 Aug;158(4):472-80. doi: 10.1111/j.1365-2141.2012.09173.x. Epub 2012 May 29.
Results Reference
result
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Phase I Study of Perifosine + Lenalidomide and Dexamethasone for Patients With Multiple Myeloma
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