Trial Outcomes & Findings for Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Multiple Myeloma (NCT NCT02043860)
NCT ID: NCT02043860
Last Updated: 2019-10-14
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
3 participants
Primary outcome timeframe
Up to 1 year post-transplant.
Results posted on
2019-10-14
Participant Flow
1 ineligible
Participant milestones
| Measure |
Total Marrow Irradiation
Escalating doses of total marrow irradiation (3Gy(gray), 6Gy, 9Gy, or 12Gy) with standard high dose melphalan prior to autologous stem cell rescue.
Total Marrow Irradiation (TMI): 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.
Autologous Transplant: 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.
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.
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|---|---|
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Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Total Marrow Irradiation
n=2 Participants
Escalating doses of total marrow irradiation (3Gy, 6Gy, 9Gy, or 12Gy) with standard high dose melphalan prior to autologous stem cell rescue.
Total Marrow Irradiation: 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.
Autologous Transplant: 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.
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.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 year post-transplant.Population: Data not collected
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.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1 TMI Dose 3Gy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1 TMI Dose 3Gy
n=2 participants at risk
This is a phase I trial. Patients will receive standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant conditioning will include targeted total marrow irradiation (TMI). The dose of TMI will increase until the maximum tolerated dose (MTD) is reached. 3 participants will be in each cohort beginning with the lowest possible dose of 3Gy to a maximum dose of 12Gy.
All Cause Mortality Total 0/2 0%
Serious Adverse Events Total 0/2 0%
Adverse Events not including serious adverse events Total 2/2 100% Oral Mucositis 2/2 100% Diarrhea 2/2 100% Nausea 1/2 50% Non-productive cough 1/2 50% Rash to face and back 1/2 50% Throat pain 1/2 50% GI bleed 1/2 50%
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|---|---|
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General disorders
Mucositis
|
100.0%
2/2 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
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100.0%
2/2 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
GI bleed
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50.0%
1/2 • Number of events 1 • 2 years
|
|
General disorders
Throat pain
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50.0%
1/2 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash to face and back
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Non-productive cough
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath on exertion
|
50.0%
1/2 • Number of events 1 • 2 years
|
Additional Information
Annette Kinsella, RN, CCRC, QA Education Specialist
UIC Cancer Center Clinical Trials Office
Phone: 312-996-5931
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place