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

February 27, 2018 updated by: AEterna Zentaris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

67

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94704
        • Investigative Site
      • Duarte, California, United States, 91010
        • Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Investigative Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • Investigative Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perifosine daily
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
Drug: perifosine
100 - 150 mg daily
Other Names:
  • D-21266
  • KRX-0401
Experimental: Perifosine daily + Dexa twice per week
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.
Drug: perifosine
100 - 150 mg daily
Other Names:
  • D-21266
  • KRX-0401
Drug: dexamethasone
20 mg twice weekly
Other Names:
  • decadron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate (the combined CR + PR + MR) with treatment perifosine
Time Frame: Every 3 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate (CR + PR + MR) with combination therapy
Time Frame: Every 3 weeks
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
Assess the safety and tolerability of perifosine alone and in combination
Time Frame: Every 3 weeks
To assess the safety and tolerability of perifosine alone and in combination with dexamethasone in patients with multiple myeloma.
Every 3 weeks
Obtain correlative data in patients with multiple myeloma treated with perifosine and in combination
Time Frame: Every 3 weeks
To obtain correlative data in patients with multiple myeloma treated with perifosine alone and in combination with dexamethasone.
Every 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AEterna Zentaris

Investigators

  • Principal Investigator: Paul Richardson, M.D, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

September 11, 2006

First Submitted That Met QC Criteria

September 11, 2006

First Posted (Estimate)

September 13, 2006

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 27, 2018

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Perifosine 212

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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