Multiple Myeloma Clinical Trial
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
Verified date | February 2012 |
Source | AEterna Zentaris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 67 |
Est. completion date | October 2011 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 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. Minor criteria: 1. Bone marrow plasmacytosis (10 to 30% plasma cells) 2. Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria 3. Lytic bone lesions 4. 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: 1. Any two of the major criteria. 2. Major criterion 1 plus minor criterion b, c or d. 3. Major criterion 3 plus minor criterion a or c. 4. Minor criteria a, b and c or a, b and d. Exclusion Criteria: 1. Renal insufficiency (serum creatinine levels > 3 mg/dL). 2. Patients who present with either ALT or AST = 2.5 X upper limit of normal. 3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine). 4. 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. 5. Subjects with a hemoglobin < 8.0 g/dL. 6. 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. 7. Women of childbearing potential (WCBP) who are pregnant, or breast-feeding or men and women who are not using adequate contraception are excluded. 8. Plasma cell leukemia. |
Country | Name | City | State |
---|---|---|---|
United States | Investigative Site | Ann Arbor | Michigan |
United States | Investigative Site | Atlanta | Georgia |
United States | Investigative Site | Berkeley | California |
United States | Investigative Site | Boston | Massachusetts |
United States | Investigative Site | Charlottesville | Virginia |
United States | Investigative Site | Chicago | Illinois |
United States | Investigative Site | Duarte | California |
Lead Sponsor | Collaborator |
---|---|
AEterna Zentaris |
United States,
Blood (ASH Annual Meeting Abstracts) 2007 110: Abstract 1164 © 2007 American Society of Hematology
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Every 3 weeks | |
Secondary | 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. | Every 3 weeks | |
Secondary | 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. | Every 3 weeks | |
Secondary | 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. | Every 3 weeks |
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