Trial Outcomes & Findings for TMI With HD Mel in ASCT for R/R Multiple Myeloma (BMT-03) (NCT NCT02043847)
NCT ID: NCT02043847
Last Updated: 2024-11-13
Results Overview
Assessing MTD of TMI of 3Gy, 6Gy and 9Gy
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Up to 60 days post-transplant.
Results posted on
2024-11-13
Participant Flow
Participant milestones
| Measure |
Cohort 1Total Marrow Irradiation (TMI) 3Gy
3Gy with standard high dose melphalan prior to autologous stem cell rescue
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
Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
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.
Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
|
Cohort 2 Total Marrow Irradiation (TMI) 6Gy
6Gy with standard high dose melphalan prior to autologous stem cell rescue
Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day
Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
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
Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
|
Cohort 3 Total Marrow Irradiation (TMI) 9Gy
9Gy with standard high dose melphalan prior to autologous stem cell rescue
Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day
Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
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
Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TMI With HD Mel in ASCT for R/R Multiple Myeloma (BMT-03)
Baseline characteristics by cohort
| Measure |
Cohort 1Total Marrow Irradiation (TMI) 3Gy
n=3 Participants
3Gy with standard high dose melphalan prior to autologous stem cell rescue
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
Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
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.
Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
|
Cohort 2 Total Marrow Irradiation (TMI) 6Gy
n=3 Participants
6Gy with standard high dose melphalan prior to autologous stem cell rescue
Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day
Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
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
Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
|
Cohort 3 Total Marrow Irradiation (TMI) 9Gy
n=6 Participants
9Gy with standard high dose melphalan prior to autologous stem cell rescue
Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day
Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
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
Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Age, Continuous
|
59 Years
n=99 Participants
|
68 Years
n=107 Participants
|
58 Years
n=206 Participants
|
61 Years
n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to 60 days post-transplant.Population: 3 participants received 3Gy, 3 participants received 6Gy and 6 participants received 9Gy
Assessing MTD of TMI of 3Gy, 6Gy and 9Gy
Outcome measures
| Measure |
Single Arm
n=12 Participants
|
Cohort 2 Total Marrow Irradiation (TMI) 6Gy
6Gy with standard high dose melphalan prior to autologous stem cell rescue
Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day
Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
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
Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
|
Cohort 3 Total Marrow Irradiation (TMI) 9Gy
9Gy with standard high dose melphalan prior to autologous stem cell rescue
Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day
Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
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
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 (MTD) of Gy
|
NA Participants
To clarify there was an insufficient number of events to determine the MTD
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 year post-transplant.Population: There was no MTD reached for any Cohort
The disease status of enrolled patients will be evaluated based on the International Myeloma Working Group Criteria. Response Criteria Stringent Complete Response (sCR) in addition to CR all of the following: 1. Normal free light chain ratio (FLC) 2. Absence of clonal cells in the bone marrow by immunohistochemistry if this is performed Complete Response (CR) requires all of the following: 1. Absence of the original monoclonal paraprotein in the serum or the urine by routine electrophoresis and by immunofixation. The presence of new monoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR. 2. Less than 5% plasma cells in a bone marrow aspirate and bone marrow biopsy if this is performed. 3. No increase in size or number of lytic bone lesions on radiologic investigation (development of compression fracture does not exclude CR and radiographs are not required to document CR if not clinically indicated) 4. Disappearance of soft tissue plasmacytoma
Outcome measures
| Measure |
Single Arm
n=3 Participants
|
Cohort 2 Total Marrow Irradiation (TMI) 6Gy
n=3 Participants
6Gy with standard high dose melphalan prior to autologous stem cell rescue
Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day
Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
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
Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
|
Cohort 3 Total Marrow Irradiation (TMI) 9Gy
n=6 Participants
9Gy with standard high dose melphalan prior to autologous stem cell rescue
Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day
Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
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
Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
|
|---|---|---|---|
|
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
|
1 Participants
|
1 Participants
|
4 Participants
|
Adverse Events
Cohort 1Total Marrow Irradiation (TMI) 3Gy
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Cohort 2 Total Marrow Irradiation (TMI) 6Gy
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Cohort 3 Total Marrow Irradiation (TMI) 9Gy
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort 1Total Marrow Irradiation (TMI) 3Gy
n=3 participants at risk
3Gy with standard high dose melphalan prior to autologous stem cell rescue
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
Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
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.
Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
|
Cohort 2 Total Marrow Irradiation (TMI) 6Gy
n=3 participants at risk
6Gy with standard high dose melphalan prior to autologous stem cell rescue
Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day
Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
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
Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
|
Cohort 3 Total Marrow Irradiation (TMI) 9Gy
n=6 participants at risk
9Gy with standard high dose melphalan prior to autologous stem cell rescue
Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day
Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
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
Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death
|
33.3%
1/3 • Number of events 1 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Cohort 1Total Marrow Irradiation (TMI) 3Gy
n=3 participants at risk
3Gy with standard high dose melphalan prior to autologous stem cell rescue
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
Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
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.
Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
|
Cohort 2 Total Marrow Irradiation (TMI) 6Gy
n=3 participants at risk
6Gy with standard high dose melphalan prior to autologous stem cell rescue
Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day
Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
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
Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
|
Cohort 3 Total Marrow Irradiation (TMI) 9Gy
n=6 participants at risk
9Gy with standard high dose melphalan prior to autologous stem cell rescue
Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day
Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant
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
Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
|
|---|---|---|---|
|
Infections and infestations
Mucositis
|
33.3%
1/3 • Number of events 1 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place