drugset / Trial / NCT01954784

Lenalidomide After Donor Stem Cell Transplant and Bortezomib in Treating Patients With High Risk Multiple Myeloma

NCT01954784

NaSingle-groupOpen-labelTreatment

Summary

This phase I trial studies the side effects and best dose of lenalidomide after donor stem cell transplant and bortezomib in treating patients with high-risk multiple myeloma. Giving low doses of chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may also the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving a bortezomib at the time of transplant may stop this from happening. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving lenalidomide after donor stem cell transplant may be an effective treatment for multiple myeloma.

Timeline

Start
2013-10-07
Primary completion
2017-01-30
Completion
2017-01-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule Subcutaneous
Subject Lenalidomide Other / unclassified 10 mg Oral
Background Cyclosporine Peptide Oral
Background Fludarabine Small molecule
Background Mycophenolate Mofetil Small molecule Oral

Indications