Melphalan and Radiation Therapy Followed By Lenalidomide in Treating Patients Who Are Undergoing Autologous Stem Cell Transplant for Stage I, Stage II, or Stage III Multiple Myeloma

Summary

RATIONALE: Melphalan, a chemotherapeutic agent, has been found to be an effective treatment choice for destroying myeloma cells, especially when given at high (bone marrow ablative) doses. Total marrow irradiation (TMI)/ablative dose radiation therapy is another modality capable of destroying myeloma cells. Autologous peripheral blood/stem cell transplant (ASCT) given after either melphalan or following TMI (aimed at the bone marrow containing areas of the skeleton, the site of origin of myeloma cells) will shorten the duration/alleviate the severity of both melphalan and marrow irradiation-associated side effects. Lenalidomide, an effective agent on its own right for the treatment of myeloma, has been shown to further enhance the beneficial effects of autologous stem cell transplants when given as maintenance therapy.

PURPOSE: This previously phase I trial established the maximum tolerated dose of TMI at 1600 cGy. The phase II part of this study is ongoing and is studying the effects of high-dose melphalan and ASCT, followed by TMI and a second ASCT, with subsequent maintenance lenalidomide. The study is conducted in patients with stages I-III myeloma, with specific emphasis on assessing complete and very good partial response rate conversions, progression-free and overall survival, and safety/feasibility of delivering the planned treatment regimen.

Conditions

• Refractory Multiple Myeloma
• Smoldering Multiple Myeloma
• Stage I Multiple Myeloma
• Stage II Multiple Myeloma
• Stage III Multiple Myeloma

Interventions

RADIATION

total marrow irradiation

Undergo irradiation

DRUG

melphalan

Given IV

PROCEDURE

peripheral blood stem cell transplantation

Undergo transplantation

BIOLOGICAL

filgrastim

Given IV

GENETIC

fluorescence in situ hybridization

Correlative studies

GENETIC

cytogenetic analysis

Correlative studies

DRUG

cyclophosphamide

Given IV

PROCEDURE

autologous-autologous tandem hematopoietic stem cell transplantation

Undergo transplantation

DRUG

lenalidomide

Given orally

Sponsors & Collaborators

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• George Somlo · City of Hope Medical Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-11-30

Primary Completion

2019-02-15

Completion

2019-02-15

Countries

• United States

Study Locations