Autologous Stem Cell Transplantation and Maintenance Therapy for Multiple Myeloma

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This trial will determine the feasibility and efficacy of lenalidomide as maintenance therapy in Multiple Myeloma patients treated with dose intensive chemotherapy (Melphalan 200 mg/m2) with autologous PBSC transplant.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Treatments: Lenalidomide; Melphalan; Thalidomide

Criteria

Inclusion Criteria:

• Must be 18 to 75 years of age.

• ECOG performance status of 0, 1 or 2.

• Patients who have a history of another malignant disorder are eligible, provided that they have not received active therapy for 5 years. Patients with basal cell and squamous cell skin cancers are eligible.

• Patients who are pregnant are ineligible.

• Patients must furnish written informed consent and HIPAA authorization for release of personal health information.

• Patients must be able to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments.

• Patients must be HIV and HTLV-I,-II antibody sero-negative.

• Patients must have adequate visceral organ function

Exclusion Criteria:

• Patients are ineligible if they have received cumulative chemotherapy doses in excess of: carmustine (BCNU) 400 mg/m2, or a cumulative anthracycline exposure in excess of 550 mg/m2 Adriamycin (doxorubicin) unless the gated-pool radionuclide cardiac scan shows greater than/equal to 45% ejection fraction.

• Patients are ineligible if they are receiving any other investigational agents.