Autologous Transplant for Multiple Myeloma

University of Minnesota (UMN)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: Cyclophosphamide + Mesna; Drug: Melphalan; Procedure: Stem Cell Transplant; Biological: Granulocyte-colony stimulating factor

Study type: Interventional

Funder types: Other

Identifiers

NCT00177047

0312M54569 (Other Identifier)

MT2003-13 (Other Identifier)

2004LS001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 363 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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363 participants in 1 patient group

Chemotherapy and Transplant Treatment

Experimental group

Description:

Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m\^2). Post-transplant maintenance therapy is then prescribed if appropriate.

Treatment:

Biological: Granulocyte-colony stimulating factor

Procedure: Stem Cell Transplant

Drug: Cyclophosphamide + Mesna

Drug: Melphalan