Busulfan, Fludarabine, Donor Stem Cell Transplant, and Cyclophosphamide in Treating Patients With Multiple Myeloma or Myelofibrosis
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|ClinicalTrials.gov Identifier: NCT03303950|
Recruitment Status : Recruiting
First Posted : October 6, 2017
Last Update Posted : May 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anemia ASXL1 Gene Mutation EZH2 Gene Mutation IDH1 Gene Mutation IDH2 Gene Mutation Plasma Cell Myeloma Primary Myelofibrosis Recurrent Plasma Cell Myeloma Secondary Myelofibrosis Thrombocytopenia||Drug: Busulfan Drug: Cyclophosphamide Drug: Fludarabine Procedure: Hematopoietic Cell Transplantation Other: Laboratory Biomarker Analysis||Phase 2|
I. To evaluate non-relapse mortality (NRM) up to day +100.
I. To evaluate non-relapse mortality (NRM) up to day +365. II. To evaluate the incidence of acute graft versus host disease (GVHD) and chronic GVHD up to day +365 post-transplant.
III. To evaluate the overall survival and disease free survival up to 1 year. IV. To evaluate clinical response and molecular response (complete response and partial response) up to 1 year.
Patients receive busulfan intravenously (IV) over 2 hours and fludarabine IV over 30 minutes on days -5 to -2. Patients undergo hematopoietic cell transplantation (HSCT) on day 0. Patients then receive cyclophosphamide IV over 60 minutes on days 3 and 4.
After completion of study treatment, patients are followed up for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Allogeneic Stem Cell Transplantation for Multiple Myeloma and Myelofibrosis|
|Actual Study Start Date :||January 29, 2018|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2022|
Experimental: Treatment (busulfan, fludarabine, HSCT, cyclophosphamide)
Patients receive busulfan IV over 2 hours and fludarabine IV over 30 minutes on days -5 to -2. Patients undergo HSCT on day 0. Patients then receive cyclophosphamide IV over 60 minutes on days 3 and 4.
Other Name: Fluradosa
Procedure: Hematopoietic Cell Transplantation
Other: Laboratory Biomarker Analysis
- Non-relapse mortality (NRM) [ Time Frame: Up to day 100 ]NRM is defined as death due to graft versus host disease, infections, sepsis, organ (lung, liver, kidney) toxicity. The outcome will be reported along with an exact binomial confidence intervals for informal comparison to the literature.
- Cumulative incidence of clinical complete response and molecular complete response (complete response and partial response) [ Time Frame: Up to 1 year ]
- Disease free survival [ Time Frame: Up to 1 year ]Kaplan-Meier techniques will be used.
- Incidence of acute graft versus host disease (GVHD) [ Time Frame: Up to day 365 ]Will be done descriptively.
- Incidence of chronic GVHD [ Time Frame: Up to day 365 ]Will be assessed based on criteria established by the National Institutes of Health Consensus Development Project in 2005, and recently updated in 2014. Will be done descriptively.
- Non-relapse mortality [ Time Frame: Up to day 365 ]Will be done descriptively.
- Overall survival [ Time Frame: Up to 1 year ]Kaplan-Meier techniques will be used.
- Relapse rate [ Time Frame: Up to day 365 ]Will be done descriptively.
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): NCT03303950
|Contact: Kolleen Hicksemail@example.com|
|United States, Utah|
|Huntsman Cancer Institute/University of Utah||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: Catherine Lee, MD 801-587-0231 Catherine.Lee@hci.utah.edu|
|Principal Investigator: Catherine Lee, MD|
|Principal Investigator:||Catherine Lee, MD||Huntsman Cancer Institute/ University of Utah|