NCT01303965

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

Phase I/II Trial of Allogeneic Peripheral Blood Stem Cell Transplantation Followed by Maintenance Therapy With Lenalidomide and Sirolimus in Patients With High-Risk Multiple Myeloma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Sherif S. Farag · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Multiple Myeloma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-02-07
• Primary completion: 2014-09-23
• Completion: 2017-07-28
• First posted: 2011-02-25
• Last updated: 2019-01-08
• Results posted: 2018-12-06

Locations

1 site across 1 country: United States