Autologous Stem Cell Transplantation and Maintenance Therapy for Multiple Myeloma (AMM-2011)

University of Virginia

Status and phase

Terminated

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: Lenalidomide

Drug: Melphalan

Study type

Interventional

Funder types

Other

Identifiers

NCT01617213

16043

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.