Trial Outcomes & Findings for Auto Transplant High Dose Melphalan vs High Dose Melphalan+Bortezomib in Pts With Multiple Myeloma Age 65 Years or Older (NCT NCT01453088)
NCT ID: NCT01453088
Last Updated: 2023-11-28
Results Overview
Progression free survival of elderly patients with multiple myeloma treated with either high-dose melphalan versus high-dose melphalan and bortezomib at 3 years
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
Participants will be followed post transplant for a minimum of 3 years, and after that may be monitored as part of the study indefinitely
Results posted on
2023-11-28
Participant Flow
Participant milestones
| Measure |
Auto Transplant High Dose Melphalan
Melphalan is administered at a dose of 200mg/m2 by rapid intravenous infusion via a central or peripheral vein over 30 minutes to one hour.
Melphalan will be given as a single dose (not split over 2 or more days) and given on day-1.
Dosing will be based on body surface area calculated using actual body weight
|
Auto Transplant High Dose Melphalan+Bortezomib
Bortezomib:
Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at least 20 hrs after the start of the melphalan infusion on day -1.
Bortezomib: Bortezomib:
Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at least 20 hrs after the start of the melphalan infusion on day -1.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
|
Overall Study
COMPLETED
|
28
|
31
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Auto Transplant High Dose Melphalan vs High Dose Melphalan+Bortezomib in Pts With Multiple Myeloma Age 65 Years or Older
Baseline characteristics by cohort
| Measure |
Auto Transplant High Dose Melphalan
n=28 Participants
Melphalan is administered at a dose of 200mg/m2 by rapid intravenous infusion via a central or peripheral vein over 30 minutes to one hour.
Melphalan will be given as a single dose (not split over 2 or more days) and given on day-1.
Dosing will be based on body surface area calculated using actual body weight
|
Auto Transplant High Dose Melphalan+Bortezomib
n=31 Participants
Bortezomib:
Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at least 20 hrs after the start of the melphalan infusion on day -1.
Bortezomib: Bortezomib:
Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at least 20 hrs after the start of the melphalan infusion on day -1.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Age, Continuous
|
69 years
n=5 Participants
|
69 years
n=7 Participants
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
31 participants
n=7 Participants
|
59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed post transplant for a minimum of 3 years, and after that may be monitored as part of the study indefinitelyProgression free survival of elderly patients with multiple myeloma treated with either high-dose melphalan versus high-dose melphalan and bortezomib at 3 years
Outcome measures
| Measure |
Auto Transplant High Dose Melphalan
n=28 Participants
Melphalan is administered at a dose of 200mg/m2 by rapid intravenous infusion via a central or peripheral vein over 30 minutes to one hour.
Melphalan will be given as a single dose (not split over 2 or more days) and given on day-1.
Dosing will be based on body surface area calculated using actual body weight
|
Auto Transplant High Dose Melphalan+Bortezomib
n=31 Participants
Bortezomib:
Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at least 20 hrs after the start of the melphalan infusion on day -1.
Bortezomib: Bortezomib:
Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at least 20 hrs after the start of the melphalan infusion on day -1.
|
|---|---|---|
|
Progression Free Survival Rate
|
13 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Overall Survival Rate
Outcome measures
| Measure |
Auto Transplant High Dose Melphalan
n=28 Participants
Melphalan is administered at a dose of 200mg/m2 by rapid intravenous infusion via a central or peripheral vein over 30 minutes to one hour.
Melphalan will be given as a single dose (not split over 2 or more days) and given on day-1.
Dosing will be based on body surface area calculated using actual body weight
|
Auto Transplant High Dose Melphalan+Bortezomib
n=31 Participants
Bortezomib:
Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at least 20 hrs after the start of the melphalan infusion on day -1.
Bortezomib: Bortezomib:
Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at least 20 hrs after the start of the melphalan infusion on day -1.
|
|---|---|---|
|
Overall Survival Rate
|
27 Participants
|
27 Participants
|
Adverse Events
Auto Transplant High Dose Melphalan
Serious events: 13 serious events
Other events: 0 other events
Deaths: 1 deaths
Auto Transplant High Dose Melphalan+Bortezomib
Serious events: 18 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Auto Transplant High Dose Melphalan
n=28 participants at risk
Melphalan is administered at a dose of 200mg/m2 by rapid intravenous infusion via a central or peripheral vein over 30 minutes to one hour.
Melphalan will be given as a single dose (not split over 2 or more days) and given on day-1.
Dosing will be based on body surface area calculated using actual body weight
|
Auto Transplant High Dose Melphalan+Bortezomib
n=31 participants at risk
Bortezomib:
Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at least 20 hrs after the start of the melphalan infusion on day -1.
Bortezomib: Bortezomib:
Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at least 20 hrs after the start of the melphalan infusion on day -1.
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
7.1%
2/28 • Number of events 2 • 3 Years Post Transplant
|
0.00%
0/31 • 3 Years Post Transplant
|
|
Infections and infestations
C Diff Infection
|
3.6%
1/28 • Number of events 1 • 3 Years Post Transplant
|
0.00%
0/31 • 3 Years Post Transplant
|
|
Musculoskeletal and connective tissue disorders
Cervical Fusion
|
0.00%
0/28 • 3 Years Post Transplant
|
3.2%
1/31 • Number of events 1 • 3 Years Post Transplant
|
|
Investigations
Death
|
0.00%
0/28 • 3 Years Post Transplant
|
3.2%
1/31 • Number of events 1 • 3 Years Post Transplant
|
|
Investigations
Death (Disease Progression)
|
0.00%
0/28 • 3 Years Post Transplant
|
6.5%
2/31 • Number of events 2 • 3 Years Post Transplant
|
|
Investigations
Death (Fall)
|
0.00%
0/28 • 3 Years Post Transplant
|
3.2%
1/31 • Number of events 1 • 3 Years Post Transplant
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
1/28 • Number of events 1 • 3 Years Post Transplant
|
3.2%
1/31 • Number of events 1 • 3 Years Post Transplant
|
|
Investigations
Disease Progression
|
10.7%
3/28 • Number of events 3 • 3 Years Post Transplant
|
35.5%
11/31 • Number of events 11 • 3 Years Post Transplant
|
|
Gastrointestinal disorders
Fall/Colitis
|
3.6%
1/28 • Number of events 1 • 3 Years Post Transplant
|
0.00%
0/31 • 3 Years Post Transplant
|
|
Investigations
Fever
|
7.1%
2/28 • Number of events 2 • 3 Years Post Transplant
|
0.00%
0/31 • 3 Years Post Transplant
|
|
Musculoskeletal and connective tissue disorders
Fractured Right Arm
|
3.6%
1/28 • Number of events 1 • 3 Years Post Transplant
|
0.00%
0/31 • 3 Years Post Transplant
|
|
Blood and lymphatic system disorders
Hemolytic Anemia
|
0.00%
0/28 • 3 Years Post Transplant
|
3.2%
1/31 • Number of events 1 • 3 Years Post Transplant
|
|
Blood and lymphatic system disorders
Heparin-induced Thrombocytopenia
|
3.6%
1/28 • Number of events 1 • 3 Years Post Transplant
|
0.00%
0/31 • 3 Years Post Transplant
|
|
Cardiac disorders
Hypotension
|
3.6%
1/28 • Number of events 1 • 3 Years Post Transplant
|
0.00%
0/31 • 3 Years Post Transplant
|
|
Renal and urinary disorders
Kidney Stone
|
3.6%
1/28 • Number of events 1 • 3 Years Post Transplant
|
0.00%
0/31 • 3 Years Post Transplant
|
|
Musculoskeletal and connective tissue disorders
Knee Surgery
|
0.00%
0/28 • 3 Years Post Transplant
|
3.2%
1/31 • Number of events 1 • 3 Years Post Transplant
|
|
Musculoskeletal and connective tissue disorders
Laminectomy
|
3.6%
1/28 • Number of events 1 • 3 Years Post Transplant
|
0.00%
0/31 • 3 Years Post Transplant
|
|
Musculoskeletal and connective tissue disorders
Lower Extremity Weakness
|
0.00%
0/28 • 3 Years Post Transplant
|
3.2%
1/31 • Number of events 1 • 3 Years Post Transplant
|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
3.6%
1/28 • Number of events 1 • 3 Years Post Transplant
|
3.2%
1/31 • Number of events 1 • 3 Years Post Transplant
|
|
Infections and infestations
Pneumonia
|
3.6%
1/28 • Number of events 1 • 3 Years Post Transplant
|
0.00%
0/31 • 3 Years Post Transplant
|
|
Infections and infestations
Shingles Rash
|
3.6%
1/28 • Number of events 1 • 3 Years Post Transplant
|
3.2%
1/31 • Number of events 1 • 3 Years Post Transplant
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/28 • 3 Years Post Transplant
|
3.2%
1/31 • Number of events 1 • 3 Years Post Transplant
|
|
Cardiac disorders
Chest Pain
|
7.1%
2/28 • Number of events 2 • 3 Years Post Transplant
|
0.00%
0/31 • 3 Years Post Transplant
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place