Autologous Transplant for Multiple Myeloma

NCT ID: NCT00177047

Last Updated: 2021-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 363 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-20
• Study Completion Date: 2020-08-01

Brief 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.

Detailed 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.

Conditions

Multiple Myeloma

Keywords

stem cell transplantation; chemotherapy; multiple myeloma; autologous

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemotherapy and Transplant Treatment

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.

Group Type: EXPERIMENTAL

Stem Cell Transplant

Intervention Type: PROCEDURE

As part of the stem cell transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover.

Cyclophosphamide + Mesna

Intervention Type: DRUG

Cyclophosphamide: 4mg/m\^2 + Mesna. Mesna is used to reduce the undesired side effects of certain chemotherapy drugs.

Melphalan

Intervention Type: DRUG

Administered intravenously 200 mg/m\^2

Granulocyte-colony stimulating factor

Intervention Type: BIOLOGICAL

Administered intravenously 10 ug/kg/day pretransplant then 5 ug/kg/day post-transplant.

Interventions

Stem Cell Transplant

As part of the stem cell transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover.

Intervention Type: PROCEDURE

Cyclophosphamide + Mesna

Cyclophosphamide: 4mg/m\^2 + Mesna. Mesna is used to reduce the undesired side effects of certain chemotherapy drugs.

Intervention Type: DRUG

Melphalan

Administered intravenously 200 mg/m\^2

Intervention Type: DRUG

Granulocyte-colony stimulating factor

Administered intravenously 10 ug/kg/day pretransplant then 5 ug/kg/day post-transplant.

Intervention Type: BIOLOGICAL

Other Intervention Names

Bone Marrow Transplant; Cytoxan; Alkeran; G-CSF

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudio Brunstein, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MT2003-13

Identifier Type: OTHER

Identifier Source: secondary_id

0312M54569

Identifier Type: OTHER

Identifier Source: secondary_id

2004LS001

Identifier Type: -

Identifier Source: org_study_id

NCT00293306

Identifier Type: -

Identifier Source: nct_alias