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

NCT01002248 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2018-02-09

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Perifosine

Perifosine will be dosed as one 50 mg pill every day of each cycle.

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.

Sponsors & Collaborators

Principal Investigators

  • Paul Richardson, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States
  • Canada
  • Czechia
  • Ireland
  • Israel
  • Russia
  • Slovakia
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01002248 on ClinicalTrials.gov