Autologous Transplant for Multiple Myeloma
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.
Procedure: Stem Cell Transplant
Drug: Cyclophosphamide + Mesna
Biological: Granulocyte-colony stimulating factor
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Autologous Transplantation for Multiple Myeloma|
- Comparison of Percentage of Patients Achieving a Complete Response [ Time Frame: 100 Days, 6 Months, 1 Year Post Treatment ] [ Designated as safety issue: No ]
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.
- Percentage of patients with extended disease-free survival [ Time Frame: 36 Months ] [ Designated as safety issue: No ]Extended disease free survival will be defined as percentage of patients surviving more than 36 months without relapse or disease progression.
- Comparison of Overall Survival [ Time Frame: 1, 2 and 3 years ] [ Designated as safety issue: No ]The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.
- Transplant related mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]In the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation.
- Incidence of relapse [ Time Frame: 1 year ] [ Designated as safety issue: No ]The return of disease after its apparent recovery/cessation.
- Incidence of disease progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Hematologic recovery [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
- Time to Progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Time to relapse [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Time to attainment of CR and CR+PR [ Time Frame: During study ] [ Designated as safety issue: No ]
- Duration of maintenance treatment [ Time Frame: During study ] [ Designated as safety issue: No ]
- Dropout rate from maintenance therapy [ Time Frame: Post transplant phase ] [ Designated as safety issue: No ]
- Incidence of toxicities [ Time Frame: During study ] [ Designated as safety issue: Yes ]
- Incidence of infections [ Time Frame: During study ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2004|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: 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.
Procedure: 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.
Other Name: Bone Marrow TransplantDrug: Cyclophosphamide + Mesna
Cyclophosphamide: 4mg/m^2 + Mesna. Mesna is used to reduce the undesired side effects of certain chemotherapy drugs.
Other Name: CytoxanDrug: Melphalan
Administered intravenously 200 mg/m^2
Other Name: AlkeranBiological: Granulocyte-colony stimulating factor
Administered intravenously 10 ug/kg/day pretransplant then 5 ug/kg/day post-transplant.
Other Name: G-CSF
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177047
|Contact: Timothy Krepskifirstname.lastname@example.org|
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Brian McClune, DO 612-624-7101 email@example.com|
|Principal Investigator:||Brian McClune, DO||Masonic Cancer Center, University of Minnesota|