Study Stopped
low accrual
Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Multiple Myeloma
BMT-02
BMT-02: A Phase I Trial of Total Marrow Irradiation in Addition to High Dose Melphalan Conditioning Prior to Autologous Transplant for Multiple Myeloma Following Initial Induction Therapy
1 other identifier
interventional
3
1 country
1
Brief Summary
In this phase I trial, patients with multiple myeloma will receive standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant conditioning will include targeted total marrow irradiation (TMI). This conventional 3+3 phase I trial will increase the dose of TMI until the maximum tolerated dose (MTD) is reached. Initial patients enrolled will receive the lowest possible dose of 3Gy. Maximum dose will be 12Gy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 multiple-myeloma
Started Jan 2014
Shorter than P25 for phase_1 multiple-myeloma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2014
CompletedFirst Submitted
Initial submission to the registry
January 21, 2014
CompletedFirst Posted
Study publicly available on registry
January 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2016
CompletedResults Posted
Study results publicly available
October 14, 2019
CompletedOctober 14, 2019
September 1, 2019
2.8 years
January 21, 2014
February 20, 2019
September 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival No Results Due to 1 Subject Came Off Treatment Within 7 Days and 1 Subject Came Off Treatment Within 5 Days. Not Enough Data to Analyze
To evaluate progression free survival (PFS) and in patients with multiple myeloma undergoing autologous stem cell transplant using the combination of high dose melphalan and total marrow irradiation.
Up to 1 year post-transplant.
Study Arms (1)
Total Marrow Irradiation
EXPERIMENTALEscalating doses of total marrow irradiation (3Gy, 6Gy, 9Gy, or 12Gy) with standard high dose melphalan prior to autologous stem cell rescue.
Interventions
Subjects in this trial will receive total body irradiation (3Gy) per day for up to four days and as little as one day. Total IMT doses: 3Gy, 6Gy, 9Gy, or 12Gy.
Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with escalating doses of total marrow irradiation prior to autologous stem cell rescue.
Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant.
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.
Eligibility Criteria
You may qualify if:
- Patients meeting criteria for symptomatic myeloma
- Patients must be high or intermediate risk of disease progression as defined by having one of the following criteria: 2.1 ISS stage 2 or 3 disease 2.2 Abnormal metaphase cytogenetics 2.3 Presence of FISH abnormalities aside from hyperdiploidy
- Patients who have received at least 2 cycles of systemic treatment of any kind in the preceding 12 months
- Patient age 18-75 years at time of enrollment
- Karnofsky performance status of ≥70
- Cardiac function: LVEF \>40%
- Hepatic: Bilirubin \<2x upper limit of normal and ALT and AST \< 2.5x the upper limit of normal
- Renal: Creatinine clearance of ≥30mL/min, estimated or calculated
- Pulmonary: DLCO, FEV1, FVC \>50% of predicted (after correction for hemoglobin)
You may not qualify if:
- Patients with diagnosis of plasma cell leukemia
- Patients with myeloma who have had any disease progression prior to enrollment
- Patients with truly non secretory myeloma (patients with light chain disease are eligible)
- Pregnant or breast-feeding
- Uncontrolled viral, fungal or bacterial infection Note: Infection is permitted if there is evidence of response to medication. Eligibility of HIV infected patients will be determined on a case-by-case basis.
- Patients who have undergone prior allograft or autologous transplant
- Prior solid organ transplant
- Patients receiving prior radiation to more than 20% of bone marrow containing areas
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UIC Cancer Center
Chicago, Illinois, 60612, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Only 2 subjects received total marrow irradiation at 3Gy dose
Results Point of Contact
- Title
- Annette Kinsella, RN, CCRC, QA Education Specialist
- Organization
- UIC Cancer Center Clinical Trials Office
Study Officials
- PRINCIPAL INVESTIGATOR
Pritesh Patel, MD
University of Illinois at Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Faculty, Assistant Professor
Study Record Dates
First Submitted
January 21, 2014
First Posted
January 23, 2014
Study Start
January 10, 2014
Primary Completion
November 7, 2016
Study Completion
November 7, 2016
Last Updated
October 14, 2019
Results First Posted
October 14, 2019
Record last verified: 2019-09