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Allo Transplant Followed by Lenalidomide and Sirolimus Maintenance in High-Risk Multiple Myeloma (MM)

NCT01303965 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2019-01-08

Study results available
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Summary

One of the complications that can occur after a stem cell transplant is called graft versus host disease (GVHD). Another complication is that multiple myeloma may come back (relapse). In this study, a drug called lenalidomide will be started 1-2 months after a transplant, or possibly later depending on recovery of your side effects. Lenalidomide and sirolimus have been shown to work together against multiple myeloma. Therefore, lenalidomide will be combined with sirolimus with the hope that this will help prolong the amount of time the disease is in remission. Researchers hope these steps will help prolong the amount of time the multiple myeloma is in remission and will decrease the chance of GvHD.

Conditions

Interventions

DRUG

Sirolimus

Start on Day -3 and continue for 1 year

DRUG

Tacrolimus

Start on Day -3 and begin tapering on Day +100 until Day +180.

DRUG

Lenalidomide

Start between Day +30 and +120 and continue for 1 year.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Sherif S. Farag

    lead OTHER

Principal Investigators

  • Sherif Farag, MD, PhD · IU Simon Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-07
Primary Completion
2014-09-23
Completion
2017-07-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01303965 on ClinicalTrials.gov