NCT00177047 - Autologous Transplant for Multiple Myeloma | Crick

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Enrollment

363

Conditions

Multiple Myeloma

Interventions

Stem Cell TransplantPROCEDURE

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 + MesnaDRUG

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

MelphalanDRUG

Administered intravenously 200 mg/m\^2

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Number of Participants Achieving a Complete Response

Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR: * Normal free light chain ratio * Absence of clonal cells in bone marrow Complete Response (CR): * Absence of the original monoclonal paraprotein * \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy * No increase in size or number of lytic bone lesions * Disappearance of soft tissue plasmacytomas.

Time frame: 100 Days post transplant

Number of Participants Achieving a Complete Response

Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR: * Normal free light chain ratio * Absence of clonal cells in bone marrow Complete Response (CR): * Absence of the original monoclonal paraprotein * \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy * No increase in size or number of lytic bone lesions * Disappearance of soft tissue plasmacytomas.

Time frame: 6 months post transplant

Number of Participants Achieving a Complete Response

Myeloma Response Definitions - Using International Uniform Response Criteria: Stringent Complete Response (sCR)requires, plus CR: * Normal free light chain ratio * Absence of clonal cells in bone marrow Complete Response (CR): * Absence of the original monoclonal paraprotein * \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy * No increase in size or number of lytic bone lesions * Disappearance of soft tissue plasmacytomas.

Time frame: 12 months post transplant

Secondary Outcomes

Number of Patients With Extended Disease-free Survival

Extended disease free survival will be defined as percentage of patients surviving more than 36 months without relapse or disease progression.

Time frame: 36 Months