Back to resultsEfficacy of Perifosine Alone and in Combination With Dexamethasone for Patients With Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
perifosine
dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Relapsed Multiple Myeloma, Refractory Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
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.
Minor criteria:
- Bone marrow plasmacytosis (10 to 30% plasma cells)
- Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
- Lytic bone lesions
- Normal immunoglobulin M (IgM) < 50 mg/dL, IgA < 100 mg/dL or IgG < 600 mg/dL.
Any of the following sets of criteria will confirm the diagnosis of multiple myeloma:
- Any two of the major criteria.
- Major criterion 1 plus minor criterion b, c or d.
- Major criterion 3 plus minor criterion a or c.
- Minor criteria a, b and c or a, b and d.
Exclusion Criteria:
- Renal insufficiency (serum creatinine levels > 3 mg/dL).
- Patients who present with either ALT or AST ≥ 2.5 X upper limit of normal.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
- Concomitant therapy medications that include corticosteroids (except as indicated for other medical conditions, or up to 100 mgs of hydrocortisone as premedication for administration of certain medications or blood products) or other chemotherapy that is or may be active against myeloma, or therapy with chemotherapy within 3 weeks prior to Day 1. Nitrosoureas must be discontinued 6 weeks prior to Day 1.
- Subjects with a hemoglobin < 8.0 g/dL.
- Any condition, including laboratory abnormalities, that in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.
- Women of childbearing potential (WCBP) who are pregnant, or breast-feeding or men and women who are not using adequate contraception are excluded.
- Plasma cell leukemia.
Sites / Locations
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Perifosine daily
Perifosine daily + Dexa twice per week
Arm Description
Patients will take three 50 mg tablets of perifosine daily at bedtime with food. Patients will be examined every three weeks. If patients have no progression it is allowed to receive 8 cycles of perifosine
Patients will take three 50 mg tablets of perifosine daily at bedtime with food until progression. If progressive disease is confirmed by a second measurement at least one week later the patient will receive a combination of 20 mg twice per week dexamethasone (dexa) and 150 mg perifosine daily at bedtime.
Outcomes
Primary Outcome Measures
Response rate (the combined CR + PR + MR) with treatment perifosine
To determine the response rate (the combined Complete Response (CR) + Partial Response (PR) + Minor Response (MR) following treatment with perifosine in patients with multiple myeloma who have relapsed following Initial front-line therapy and are refractory to their most recent therapy.
Secondary Outcome Measures
Response rate (CR + PR + MR) with combination therapy
To determine the response rate (CR + PR + MR) following treatment with combination therapy with perifosine plus dexamethasone in patients with multiple myeloma who have relapsed or were refractory to their most recent therapy before study enrollment, and failed to respond to or have relapsed following treatment with perifosine alone.
Assess the safety and tolerability of perifosine alone and in combination
To assess the safety and tolerability of perifosine alone and in combination with dexamethasone in patients with multiple myeloma.
Obtain correlative data in patients with multiple myeloma treated with perifosine and in combination
To obtain correlative data in patients with multiple myeloma treated with perifosine alone and in combination with dexamethasone.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00375791
Brief Title
Efficacy of Perifosine Alone and in Combination With Dexamethasone for Patients With Multiple Myeloma
Official Title
An Open-Label Phase II Study of the Safety and Efficacy of Perifosine Alone and in Combination With Dexamethasone for Patients With Relapsed or Relapsed/Refractory Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
October 2011 (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 2 study of perifosine in patients with multiple myeloma. Patients will receive perifosine 150 mg at bedtime (qhs) daily. Patients will be assessed by serum and/or urine-electrophoresis at least every 3 weeks.
Detailed Description
Treatment: Patients will take three 50 mg tablets of perifosine qhs daily with food. All patients should continue therapy unless disease progression is documented on two occasions at least 1 week apart. Progressing patients will have dexamethasone 20 mg twice per week added to the perifosine. Patients who experience toxicity may continue on treatment with doses delayed or reduced.
Evaluations: Serum and/or urine-electrophoresis will be evaluated for progression or response at 3 week intervals.
This study will enroll a total of up to 64 patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Relapsed Multiple Myeloma, Refractory Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Perifosine daily
Arm Type
Experimental
Arm Description
Patients will take three 50 mg tablets of perifosine daily at bedtime with food. Patients will be examined every three weeks. If patients have no progression it is allowed to receive 8 cycles of perifosine
Arm Title
Perifosine daily + Dexa twice per week
Arm Type
Experimental
Arm Description
Patients will take three 50 mg tablets of perifosine daily at bedtime with food until progression. If progressive disease is confirmed by a second measurement at least one week later the patient will receive a combination of 20 mg twice per week dexamethasone (dexa) and 150 mg perifosine daily at bedtime.
Intervention Type
Drug
Intervention Name(s)
perifosine
Other Intervention Name(s)
D-21266, KRX-0401
Intervention Description
100 - 150 mg daily
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
decadron
Intervention Description
20 mg twice weekly
Primary Outcome Measure Information:
Title
Response rate (the combined CR + PR + MR) with treatment perifosine
Description
To determine the response rate (the combined Complete Response (CR) + Partial Response (PR) + Minor Response (MR) following treatment with perifosine in patients with multiple myeloma who have relapsed following Initial front-line therapy and are refractory to their most recent therapy.
Time Frame
Every 3 weeks
Secondary Outcome Measure Information:
Title
Response rate (CR + PR + MR) with combination therapy
Description
To determine the response rate (CR + PR + MR) following treatment with combination therapy with perifosine plus dexamethasone in patients with multiple myeloma who have relapsed or were refractory to their most recent therapy before study enrollment, and failed to respond to or have relapsed following treatment with perifosine alone.
Time Frame
Every 3 weeks
Title
Assess the safety and tolerability of perifosine alone and in combination
Description
To assess the safety and tolerability of perifosine alone and in combination with dexamethasone in patients with multiple myeloma.
Time Frame
Every 3 weeks
Title
Obtain correlative data in patients with multiple myeloma treated with perifosine and in combination
Description
To obtain correlative data in patients with multiple myeloma treated with perifosine alone and in combination with dexamethasone.
Time Frame
Every 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Minor criteria:
Bone marrow plasmacytosis (10 to 30% plasma cells)
Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
Lytic bone lesions
Normal immunoglobulin M (IgM) < 50 mg/dL, IgA < 100 mg/dL or IgG < 600 mg/dL.
Any of the following sets of criteria will confirm the diagnosis of multiple myeloma:
Any two of the major criteria.
Major criterion 1 plus minor criterion b, c or d.
Major criterion 3 plus minor criterion a or c.
Minor criteria a, b and c or a, b and d.
Exclusion Criteria:
Renal insufficiency (serum creatinine levels > 3 mg/dL).
Patients who present with either ALT or AST ≥ 2.5 X upper limit of normal.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
Concomitant therapy medications that include corticosteroids (except as indicated for other medical conditions, or up to 100 mgs of hydrocortisone as premedication for administration of certain medications or blood products) or other chemotherapy that is or may be active against myeloma, or therapy with chemotherapy within 3 weeks prior to Day 1. Nitrosoureas must be discontinued 6 weeks prior to Day 1.
Subjects with a hemoglobin < 8.0 g/dL.
Any condition, including laboratory abnormalities, that in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.
Women of childbearing potential (WCBP) who are pregnant, or breast-feeding or men and women who are not using adequate contraception are excluded.
Plasma cell leukemia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Richardson, M.D
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Investigative Site
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Investigative Site
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Investigative Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Investigative Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Investigative Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
Investigative Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Blood (ASH Annual Meeting Abstracts) 2007 110: Abstract 1164 © 2007 American Society of Hematology
Results Reference
result
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Efficacy of Perifosine Alone and in Combination With Dexamethasone for Patients With Multiple Myeloma
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