Autologous Transplant for Multiple Myeloma

• Status: Completed
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study of a regimen of melphalan and autologous stem cells for patients with multiple myeloma. We hypothesize that this particular regimen will improve the survival of these patients.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Treatments: Cyclophosphamide; Lenograstim; Melphalan; Mesna; Sargramostim

Criteria

Inclusion Criteria:

• Patients meeting the Durie and Salmon criteria for initial diagnosis of multiple myeloma, requiring therapy and meeting one of the following:

• After initial therapy in either first complete or partial remission or no objective response

• After achieving initial response and later disease progression, patient will be eligible after subsequent therapy upon achievement of either complete or partial response

• Is not eligible or has refused any protocols of higher priority

• 18 - 75 years of age

• Adequate organ function defined as:

• Hematologic: hemoglobin ≥ 8 gm/dl (untransfused), white blood cells (WBC) ≥ 3000/μl, absolute neutrophil count (ANC) ≥ 1500/μl, platelets ≥ 100,000/μl (untransfused)

• Cardiac: no active ischemia, left ventricular ejection fraction > 45% by MUGA scan

• Hepatic: bilirubin < 2.0 mg/dl, ALT < 3x the upper limit of normal

• Pulmonary: FEV1-Forced Expiratory Volume in One Second AND Forced vital capacity (FVC) >50% predicted and Carbon Monoxide Diffusing Capacity (DLCO) (corrected) > 50% predicted

• Performance status: Karnofsky performance of > 80%.

• Free of active uncontrolled infection at the time of study entry.

• At time of study enrollment > 4 weeks from prior myelosuppressive chemotherapy; and > 6 weeks from prior nitrosoureas.

• Patients must exercise informed voluntary consent and sign a consent form approved by the University of Minnesota IRB: Human Subjects Committee.

Exclusion Criteria:

• Patients will be ineligible if they have advanced myeloma refractory and unresponsive to salvage chemotherapy regimens.

• Female patients who are pregnant (positive b-HCG) or breastfeeding will be excluded from study entry. In addition fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment, particularly after thalidomide will also be excluded from study entry.