Autologous Stem Cell Transplantation and Maintenance Therapy for Multiple Myeloma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Maintenance Lenalidomide After Melphalan

Group Type EXPERIMENTAL

Melphalan

Intervention Type DRUG

200 mg/m2/IV

Lenalidomide

Intervention Type DRUG

10 mg daily continuously for the first 3 months, then increased to 15 mg daily as long as the patient tolerates the drug.

Interventions

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Melphalan

200 mg/m2/IV

Intervention Type DRUG

Lenalidomide

10 mg daily continuously for the first 3 months, then increased to 15 mg daily as long as the patient tolerates the drug.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No