Efficacy of Perifosine Alone and in Combination With Dexamethasone for Patients With Multiple Myeloma

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT00375791

Run by

AEterna Zentaris

People needed

67

Starts

2005-12-01

Expected to finish

2011-10-01

Last updated by the study team

2018-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigative Site — Berkeley, California, United States
• Investigative Site — Duarte, California, United States
• Investigative Site — Atlanta, Georgia, United States
• Investigative Site — Chicago, Illinois, United States
• Investigative Site — Boston, Massachusetts, United States
• Investigative Site — Ann Arbor, Michigan, United States
• Investigative Site — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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