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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AEterna Zentaris
ClinicalTrials.gov Identifier:
NCT00375791
First received: September 11, 2006
Last updated: February 11, 2014
Last verified: February 2012
  Purpose

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 Intervention Phase
Multiple Myeloma
Drug: perifosine
Drug: dexamethasone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AEterna Zentaris:

Primary Outcome Measures:
  • Response rate (the combined complete response [CR] + partial response [PR] + minor response [MR]) following treatment with perifosine [ Time Frame: Every 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate (CR + PR + MR) following treatment with combination therapy with perifosine plus dexamethasone [ Time Frame: Every 3 weeks ] [ Designated as safety issue: No ]
  • Assess the safety and tolerability of perifosine alone and in combination with dexamethasone [ Time Frame: Every 3 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: December 2005
Study Completion Date: October 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: perifosine 150 mg daily Drug: perifosine
100 - 150 mg daily
Other Name: perifosine
Drug: dexamethasone
20 mg twice weekly
Other Name: decadron

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375791

Locations
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
Investigators
Principal Investigator: Paul Richardson, M.D Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: AEterna Zentaris
ClinicalTrials.gov Identifier: NCT00375791     History of Changes
Other Study ID Numbers: Perifosine 212
Study First Received: September 11, 2006
Last Updated: February 11, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014