Melphalan and Stem Cell Transplant Before Total-Body Irradiation and Donor Stem Cell Transplant in Treating Patients With Stage I-III Multiple Myeloma

Completed · Phase 1/Phase 2

Conditions studied: Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

In brief

In this study donor bone marrow transplantation is divided into a two step process to try to significantly reduce the side effects of the procedure yet still provide patients with multiple myeloma the benefits of this procedure

Key facts

Study ID

NCT00003954

Run by

Fred Hutchinson Cancer Center

People needed

40

Starts

1999-03-01

Last updated by the study team

2020-02-06

Who can join

Age: any, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meet Salmon and Durie criteria for initial diagnosis of multiple myeloma; transplant will be offered to patients with stage II or III multiple myeloma (MM) at diagnosis or have received chemotherapy and/or radiation therapy for progressive MM after initial diagnosis of stage I disease
• The patient must have the capacity to give informed consent
• Have received at least 4 cycles of conventional dose chemotherapy for MM
• DONOR: HLA genotypically identical sibling
• DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis for both peripheral blood stem cell (PBSC) allograft and subsequent DLI
• DONOR: Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian)
• DONOR: Age < 75, older donors may be considered after consultation by Psychological Consultation Center (PCC)

You may not qualify if…

• Karnofsky score less than 60, unless due solely to myeloma
• Left ventricular ejection fraction less than 40%
• Bilirubin greater than 2 X the upper limit of normal
• Serum glutamic pyruvic transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) > 2 X the upper limit of normal
• Diffusion lung capacity of carbon monoxide (DLCO) < 50% (corrected) or receiving continuous supplemental oxygen
• Patients with poorly controlled hypertension
• Pregnancy
• Seropositive for the human immunodeficiency virus
• Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
• Creatinine clearance < 40 cc/min at the time of initial autografting evaluation
• Prior autograft (can be treated on alternative protocol)
• DONOR: Identical twin
• DONOR: Age less than 12 years
• DONOR: Pregnancy
• DONOR: Infection with human immunodeficiency virus (HIV)
• DONOR: Inability to achieve adequate venous access
• DONOR: Known allergy to G-CSF
• DONOR: Current serious systemic illness
• DONOR: Failure to meet Fred Hutchinson Cancer Research Center (FHCRC) criteria for stem cell donation as described in the standard practice guidelines of the institution

Where it is running

• City of Hope — Duarte, California, United States
• University of Colorado — Denver, Colorado, United States
• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States
• University of Torino — Torino, Italy

Full record on ClinicalTrials.gov

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