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

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ClinicalTrials.gov Identifier: NCT00375791
Recruitment Status : Completed
First Posted : September 13, 2006
Last Update Posted : February 13, 2014
Information provided by (Responsible Party):
AEterna Zentaris

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: perifosine Drug: dexamethasone Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2005
Primary Completion Date : December 2010
Study Completion Date : October 2011

Arm Intervention/treatment
Experimental: perifosine 150 mg daily Drug: perifosine
100 - 150 mg daily
Drug: dexamethasone
20 mg twice weekly
Other Name: decadron

Primary Outcome Measures :
  1. Response rate (the combined complete response [CR] + partial response [PR] + minor response [MR]) following treatment with perifosine [ Time Frame: Every 3 weeks ]

Secondary Outcome Measures :
  1. Response rate (CR + PR + MR) following treatment with combination therapy with perifosine plus dexamethasone [ Time Frame: Every 3 weeks ]
  2. Assess the safety and tolerability of perifosine alone and in combination with dexamethasone [ Time Frame: Every 3 weeks ]
  3. Obtain correlative data in patients with multiple myeloma treated with perifosine alone and in combination with dexamethasone (NOTE: Centers may choose not to participate in correlative studies) [ Time Frame: Every 3 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00375791

United States, California
Investigative Site
Berkeley, California, United States, 94704
Investigative Site
Duarte, California, United States, 91010
United States, Georgia
Investigative Site
Atlanta, Georgia, United States, 30322
United States, Illinois
Investigative Site
Chicago, Illinois, United States, 60611
United States, Massachusetts
Investigative Site
Boston, Massachusetts, United States, 02115
United States, Michigan
Investigative Site
Ann Arbor, Michigan, United States, 48103
United States, Virginia
Investigative Site
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
AEterna Zentaris
Principal Investigator: Paul Richardson, M.D Dana-Farber Cancer Institute

Blood (ASH Annual Meeting Abstracts) 2007 110: Abstract 1164 © 2007 American Society of Hematology

Responsible Party: AEterna Zentaris
ClinicalTrials.gov Identifier: NCT00375791     History of Changes
Other Study ID Numbers: Perifosine 212
First Posted: September 13, 2006    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2012

Keywords provided by AEterna Zentaris:
Relapsed Multiple Myeloma
Refractory Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors