Autologous Transplant for Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00177047|
Recruitment Status : Active, not recruiting
First Posted : September 15, 2005
Last Update Posted : February 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Procedure: Stem Cell Transplant Drug: Cyclophosphamide + Mesna Drug: Melphalan Biological: Granulocyte-colony stimulating factor||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||363 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autologous Transplantation for Multiple Myeloma|
|Actual Study Start Date :||April 20, 2004|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2020|
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
- Comparison of Percentage of Patients Achieving a Complete Response [ Time Frame: 100 Days, 6 Months, 1 Year Post Treatment ]
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 ]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 ]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 ]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 ]The return of disease after its apparent recovery/cessation.
- Incidence of disease progression [ Time Frame: 1 year ]
- Hematologic recovery [ Time Frame: Day 42 ]
- Time to Progression [ Time Frame: 1 year ]
- Time to relapse [ Time Frame: 1 year ]
- Time to attainment of CR and CR+PR [ Time Frame: During study ]
- Duration of maintenance treatment [ Time Frame: During study ]
- Dropout rate from maintenance therapy [ Time Frame: Post transplant phase ]
- Incidence of toxicities [ Time Frame: During study ]
- Incidence of infections [ Time Frame: During study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00177047
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Brian McClune, DO||Masonic Cancer Center, University of Minnesota|