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Assessment of Efficacy and Safety of Perifosine, Bortezomib and Dexamethasone in Multiple Myeloma Patients

This study has been terminated.
Sponsor:
Collaborator:
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
AEterna Zentaris
ClinicalTrials.gov Identifier:
NCT01002248
First received: October 23, 2009
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  Purpose

This is a randomized Phase III study to evaluate the efficacy and safety of perifosine when added to the combination of bortezomib and dexamethasone in multiple myeloma patients who have relapsed on a prior bortezomib treatment regimen.


Condition Intervention Phase
Multiple Myeloma
 Drug: Perifosine
Drug: Perifosine Placebo
Drug: Bortezomib
Drug: Dexamethasone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study to Assess the Efficacy and Safety of Perifosine Added to the Combination of Bortezomib and Dexamethasone in Multiple Myeloma Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AEterna Zentaris:

Primary Outcome Measures:
  • Determine the PFS (progression free survival) in patients with multiple myeloma, treated with perifosine, bortezomib and dexamethasone compared to patients treated with placebo, bortezomib and dexamethasone [ Time Frame: 6 - 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Overall response rate [ Time Frame: 6 - 24 months ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 135
Study Start Date: December 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Perifosine + Bortezomib + Dexamethasone Drug: Perifosine
Perifosine will be dosed as one 50 mg pill every day of each cycle.
Drug: Bortezomib
Bortezomib will be dosed at 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days.
Drug: Dexamethasone
Dexamethasone will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
Placebo Comparator: Placebo + Bortezomib + Dexamethasone Drug: Perifosine Placebo
Perifosine placebo will be dosed as one 50 mg pill every day of each cycle.
Drug: Bortezomib
Bortezomib will be dosed at 1.3 mg/m2 on Days 1, 4, 8, and 11 every 21 days.
Drug: Dexamethasone
Dexamethasone will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.

Detailed Description:

A pre-planned interim analysis is expected to take place in Q1 of 2013.

  Eligibility

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

Inclusion Criteria:

  • Patient was previously diagnosed with multiple myeloma based on standard diagnostic criteria.
  • Patients must have relapsed (progressed > 60 days) after their last dose of bortezomib-based therapy. In addition, patients may be relapsed or refractory to other non-bortezomib-based therapies.
  • Patient has received at least 1 but not more than 4 prior anti-myeloma regimens and has progressive disease after the most recent treatment regimen.
  • Patients must have adequate organ and marrow function.

Exclusion Criteria:

  • Patients must not be refractory to any bortezomib-containing regimen.
  • History of allergic reactions or intolerance attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine), bortezomib or dexamethasone or any of their components.
  • Prior treatment with perifosine or an investigational proteasome inhibitor.
  • Chemotherapy or other therapy experimental or proven that is or may be active against myeloma within two weeks (14 days) prior to Cycle 1 Day 1.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002248

  Show 88 Study Locations
Sponsors and Collaborators
AEterna Zentaris
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Paul Richardson, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: AEterna Zentaris
ClinicalTrials.gov Identifier: NCT01002248     History of Changes
Other Study ID Numbers: Perifosine 339
Study First Received: October 23, 2009
Last Updated: March 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AEterna Zentaris:
Multiple Myeloma
Relapsed multiple myeloma
Refractory multiple myeloma
Relapsed 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
Bortezomib
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

ClinicalTrials.gov processed this record on May 23, 2013