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Autologous Stem Cell Transplant With Pomalidomide (CC-4047®) Maintenance Versus Continuous Clarithromycin/ Pomalidomide / Dexamethasone Salvage Therapy in Relapsed or Refractory Multiple Myeloma

NCT01745588 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-09-11

No results posted yet for this study

Summary

The purpose of this study is to see whether pomalidomide (also known as Pomalyst) reduces the number of myeloma cells in the bones, and to see what is the best way to use pomalidomide in patients with myeloma. To do this, the investigators want to compare two types of treatment using pomalidomde. This is a randomized trial which means that the decision as to which treatment the patient will receive will be made by a computer, much like flipping a coin.

All patients start by receiving 4 cycles of clarithromycin, pomalidomide and dexamethasone (ClaPD). After 4 cycles, half of the patients will undergo an autologous stem cell transplant followed by pomalidomide (Group 1). The other half of the patients will continue to receive ClaPD for 9 cycles to be followed by pomalidomide maintenance. (Group 2).

At the end of the study, the two groups will be compared to see if there is a difference in disease outcome.

Conditions

Interventions

DRUG

Pomalidomide

PROCEDURE

stem cell

DRUG

Dexamethasone

DRUG

Clarithromycin

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    collaborator OTHER

  • North Shore University Hospital

    collaborator OTHER

  • Rutgers Cancer Institute of New Jersey

    collaborator OTHER

  • State University of New York - Upstate Medical University

    collaborator OTHER

  • Memorial Sloan Kettering Cancer Center

    lead OTHER

Principal Investigators

  • Sergio Giralt, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2025-09-03
Completion
2025-09-03

Countries

  • United States

Study Locations

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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 NCT01745588 on ClinicalTrials.gov