A Safety and Efficacy Study of Carfilzomib and Pomalidomide With Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

NCT01464034 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2022-08-01

No results posted yet for this study

Summary

This is a dose finding pilot study to evaluate the safety and determine the maximum tolerated dose of the combination of carfilzomib and pomalidomide with dexamethasone (CPD) in patients with relapsed or refractory multiple myeloma followed by a phase II expansion at the MTD to evaluate efficacy.

Conditions

Interventions

DRUG

Carfilzomib

IV over 30 minutes on Days 1,2,8,9,15, and 16 every 28 days

DRUG

Pomalidomide

PO daily on Days 1-21, every 28 Days

DRUG

Dexamethasone

40 mg weekly PO or IV on Days 1, 8, 15, and 22, every 28 days.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY
  • Celgene Corporation

    collaborator INDUSTRY
  • Criterium, Inc.

    lead INDUSTRY

Principal Investigators

  • Jatin Shah, MD · AMyC

  • Brian GM Durie, MD · AMyC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01464034 on ClinicalTrials.gov