Autologous Stem Cell Transplantation and Maintenance Therapy for Multiple Myeloma

Study Overview
=================
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.

Official Title
-----------------
Autologous Peripheral Blood Stem Cell Transplantation and Maintenance Lenalidomide After High-dose Melphalan for Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Melphalan
* Drug: Lenalidomide


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maintenance Lenalidomide After Melphalan<br> | Drug: Melphalan<br>* 200 mg/m2/IV<br>Drug: Lenalidomide<br>* 10 mg daily continuously for the first 3 months, then increased to 15 mg daily as long as the patient tolerates the drug.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event Free Survival | Duration of time until patient experiences an event (recurrence, relapse or death) | 3 years | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Myeloma