Phase I Study of Perifosine + Lenalidomide and Dexamethasone for Patients With Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AEterna Zentaris
ClinicalTrials.gov Identifier:
NCT00415064
First received: December 20, 2006
Last updated: July 3, 2012
Last verified: November 2011
  Purpose

This is a phase I study of perifosine in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma. The current protocol will enroll patients with relapsed or refractory multiple myeloma requiring second or third line therapy. Six patients each will be treated with at one of 4 dose levels in a phase 1 study. All patients will receive perifosine, lenalidomide and dexamethasone of each 28 day cycle. The doses of perifosine and lenalidomide will be varied in each group. The dose of dexamethasone will remain constant.


Condition Intervention Phase
Multiple Myeloma
Drug: Perifosine
Drug: Lenalidomide
Drug: Dexamethasone
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Phase I Study of the Safety of Perifosine in Combination With Lenalidomide and Dexamethasone for Patients With Relapsed or Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by AEterna Zentaris:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: Every cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinically significant changes in the patient's physical examination, vital signs, and clinical laboratory results [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: December 2006
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Perifosine
    Perifosine given in either 50 mg or 100 mg / day
    Drug: Lenalidomide
    Lenalidomide given in either 15 or 25 mg / day
    Drug: Dexamethasone
    Dexamethasone given in 20 mg / day
Detailed Description:

This is a phase I study of perifosine in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma. All patients will receive lenalidomide daily for days 1 to 21 of each 28 day cycle. Perifosine will be given daily qhs with food. Dexamethasone will be given on days 1-4, 9-12 and 17-20 for 4 cycles. After 4 cycles dexamethasone will be given only on days 1-4. Four dose levels will be studied:

  1. Perifosine 50 mg, lenalidomide 15 mg and dexamethasone 20 mg
  2. Perifosine 50 mg, lenalidomide 25 mg and dexamethasone 20 mg
  3. Perifosine 100 mg, lenalidomide 15 mg and dexamethasone 20 mg
  4. Perifosine 100 mg, lenalidomide 25 mg and dexamethasone 20 mg

Six patients will be enrolled at each dose level until the maximum tolerated dose (MTD) is reached. Six additional patients will be treated at the MTD.

  Eligibility

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

Inclusion Criteria:

  • Subject was previously diagnosed with multiple myeloma based on standard diagnostic criteria, as follows.
  • 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.
  • Patients must have relapsed or refractory disease (refractory is defined as progression during treatment or within 60 days after the completion of treatment) requiring 2nd or 3rd line therapy
  • Patients refractory to a combination of lenalidomide and dexamethasone will not be eligible. Patients may have received lenalidomide and/or dexamethasone

Exclusion Criteria:

  • Renal insufficiency (serum creatinine levels > 3 mg/dL)..
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
  • Known hypersensitivity to thalidomide
  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: NCT00415064

Locations
United States, Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
AEterna Zentaris
Investigators
Study Chair: Andrzej J Jakubowiak, MD, PhD University of Michigan
  More Information

Publications:
Responsible Party: AEterna Zentaris
ClinicalTrials.gov Identifier: NCT00415064     History of Changes
Other Study ID Numbers: Perifosine 127
Study First Received: December 20, 2006
Last Updated: July 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AEterna Zentaris:
Multiple Myeloma
Perifosine
Lenalidomide
Dexamethasone

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
Lenalidomide
Thalidomide
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

ClinicalTrials.gov processed this record on September 29, 2014