Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Relapsed or Refractory Multiple Myeloma (BMT-03) (BMT-03)
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|ClinicalTrials.gov Identifier: NCT02043847|
Recruitment Status : Active, not recruiting
First Posted : January 23, 2014
Last Update Posted : February 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma, Relapsed Multiple Myeloma, Refractory to Standard Treatment||Radiation: Total Marrow Irradiation Drug: Melphalan Drug: Filgrastim (G-CSF) Procedure: Autologous transplant||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||BMT-03: A Phase I Trial of Total Marrow Irradiation in Addition to High Dose Melphalan Conditioning Prior to Autologous Transplant for Patients With Relapsed or Refractory Multiple Myeloma|
|Actual Study Start Date :||January 14, 2014|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Total Marrow Irradiation
Escalating doses of total marrow irradiation (3Gy, 6Gy, or 9Gy) with standard high dose melphalan prior to autologous stem cell rescue.
Radiation: Total Marrow Irradiation
Subjects in this trial will receive total marrow irradiation (3Gy) per day for up to four days and as little as one day. Total IMT doses: 3Gy, 6Gy, or 9Gy.
Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant.
Other Name: Alkeran ®
Drug: Filgrastim (G-CSF)
Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC > 1000/mm^3 over period of 3 days.
Other Name: Neupogen®
Procedure: Autologous transplant
Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with autologous stem cell rescue.
- Maximum tolerated dose of TMI [ Time Frame: Up to 60 days post-transplant. ]To establish the maximal tolerated dose of total marrow irradiation which can be added to high dose melphalan conditioning in patients with multiple myeloma undergoing autologous stem cell transplant for relapsed/ refractory myeloma.
- Progression Free Survival [ Time Frame: Up to 1 year post-transplant. ]To evaluate progression free survival (PFS) and in patients with multiple myeloma (relapsed or refractory) undergoing autologous stem cell transplant using the combination of high dose melphalan and total marrow irradiation.
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): NCT02043847
|United States, Illinois|
|University of Illinois Cancer Center|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Pritesh Patel, MD||University of Illinois at Chicago|