Autologous Transplant for Multiple Myeloma

Last updated: November 7, 2021
Sponsor: Masonic Cancer Center, University of Minnesota
Overall Status: Completed

Phase

2/3

Condition

Multiple Myeloma

Leukemia

Lymphoproliferative Disorders

Treatment

N/A

Clinical Study ID

NCT00177047
2004LS001
MT2003-13
0312M54569
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients meeting the Durie and Salmon criteria for initial diagnosis of multiplemyeloma, requiring therapy and meeting one of the following:
  • After initial therapy in either first complete or partial remission or noobjective response
  • After achieving initial response and later disease progression, patient will beeligible after subsequent therapy upon achievement of either complete or partialresponse
  • 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 MUGAscan
  • 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 bythe University of Minnesota IRB: Human Subjects Committee.

Exclusion

Exclusion Criteria:

  • Patients will be ineligible if they have advanced myeloma refractory and unresponsiveto salvage chemotherapy regimens.
  • Female patients who are pregnant (positive b-HCG) or breastfeeding will be excludedfrom study entry. In addition fertile men or women unwilling to use contraceptivetechniques during and for 12 months following treatment, particularly afterthalidomide will also be excluded from study entry.

Study Design

Total Participants: 363
Study Start date:
April 20, 2004
Estimated Completion Date:
August 01, 2020

Study Description

Before starting treatment in this study, the bone marrow transplant (BMT) doctor will check the subject's general health. Subjects will have the following tests and evaluations to find out if they can participate:--Medical history and physical examination, including height and weight.--Blood tests (approximately 4 - 5 tablespoons) --Urine tests--Chest x-ray--Electrocardiogram (ECG or EKG)--Heart Scan (MUGA)--Pulmonary Function Test (PFT)--Bone marrow biopsies and aspirates. --If Female subjects of child-bearing age will have a serum pregnancy test performed. After eligible patients have been completely staged and exercised consent, they may undergo one cycle of chemotherapy (cyclophosphamide and Mesna) and growth factor (G-CSF) to effect cytoreduction and mobilization of PBSC for collection. All patients will receive high-dose melphalan followed by an autologous stem cell transplant (SCT). Blood tests will be performed frequently to evaluate the subject's response to treatment and possible side effects of treatment. If necessary, platelet and red cell transfusions will be given to maintain adequate levels and antibiotics will be given to treat or prevent infection. Subjects may also require intravenous nutritional support and pain medications during or after transplantation. The study coordinators will collect health information over three years. They will collect information every week for 100 days, then at 6 months, 1 year, 2 years, and 3 years.

Connect with a study center

  • Masonic Cancer Center, University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

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