Autologous Stem Cell Transplantation and Maintenance Therapy for Multiple Myeloma

Phase 2

Terminated

• Conditions: Multiple Myeloma
• Interventions: Drug: Melphalan; Drug: Lenalidomide

• Registration Number: NCT01617213
• Lead Sponsor: University of Virginia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-06-08
• Study First Submitted QC: 2012-06-11
• Study First Posted: 2012-06-12
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-20
• Last Update Posted: 2013-06-21
• Primary Completion: 2015-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Maintenance Lenalidomide After Melphalan	Melphalan	-
Maintenance Lenalidomide After Melphalan	Lenalidomide	-

Primary Outcome Measures

Name	Time	Method
Event Free Survival	3 years	Duration of time until patient experiences an event (recurrence, relapse or death)

Secondary Outcome Measures

Name	Time	Method
Disease Response	2 years	Number of patients that have complete and very good partial responses.
Overall survival	4 years	Duration of time from Day 0 until death.
Grade > 2 toxicities	4 years	Percent of patients experiencing one or more toxicity greater than 2.
Incidence of infections	4 years	Percent of patients experiencing a definite or probable viral, fungal or bacterial infection.
Treatment related Mortality	4 years	Number of patients that experience a death from causes other relapse or progression.

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States