Trial Outcomes & Findings for Velcade, Trisenox, Vitamin C and Melphalan for Myeloma Patients (NCT NCT00469209)
NCT ID: NCT00469209
Last Updated: 2020-09-24
Results Overview
Number of participants with CR at Day 180 who had maintained CR for at minimum of 4 weeks, and who had: No monoclonal protein in urine/serum when analyzed by immunofixation electrophoresis; bone marrow normal by morphological examination with \<5% plasma cells, \<1% aneuploid light chain restricted population by flow cytometry for DNA/cIg; and, while healing of bony lesion is not required, no new lytic lesion should appear. Further compression fracture of spine not considered progressive disease.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Baseline through Day 180, with assessments at Day 90 and Day 180
Results posted on
2020-09-24
Participant Flow
Recruitment period June 2006 to December 2008. All participants recruited at UT MD Anderson Cancer Center.
Participant milestones
| Measure |
No Bortezomib
Melphalan 100 mg/m\^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
|
Bortezomib 1.0 mg/m^2
Bortezomib (Level 1) 1.0 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m\^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
|
Bortezomib 1.5 mg/m^2
Bortezomib (Level 2) 1.5 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
No Bortezomib
Melphalan 100 mg/m\^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
|
Bortezomib 1.0 mg/m^2
Bortezomib (Level 1) 1.0 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m\^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
|
Bortezomib 1.5 mg/m^2
Bortezomib (Level 2) 1.5 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
Baseline Characteristics
Velcade, Trisenox, Vitamin C and Melphalan for Myeloma Patients
Baseline characteristics by cohort
| Measure |
No Bortezomib
n=20 Participants
Melphalan 100 mg/m\^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
|
Bortezomib 1.0 mg/m^2
n=20 Participants
Bortezomib (Level 1) 1.0 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m\^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
|
Bortezomib 1.5 mg/m^2
n=20 Participants
Bortezomib (Level 2) 1.5 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
59 years
n=7 Participants
|
64 years
n=5 Participants
|
60 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
60 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 180, with assessments at Day 90 and Day 180Population: Analysis was per protocol.
Number of participants with CR at Day 180 who had maintained CR for at minimum of 4 weeks, and who had: No monoclonal protein in urine/serum when analyzed by immunofixation electrophoresis; bone marrow normal by morphological examination with \<5% plasma cells, \<1% aneuploid light chain restricted population by flow cytometry for DNA/cIg; and, while healing of bony lesion is not required, no new lytic lesion should appear. Further compression fracture of spine not considered progressive disease.
Outcome measures
| Measure |
No Bortezomib
n=20 Participants
Melphalan 100 mg/m\^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
|
Bortezomib 1.0 mg/m^2
n=20 Participants
Bortezomib (Level 1) 1.0 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m\^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
|
Bortezomib 1.5 mg/m^2
n=20 Participants
Bortezomib (Level 2) 1.5 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
|
|---|---|---|---|
|
Number of Patients Reaching Complete Response (CR)
|
4 participants
|
1 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Baseline to event occurence (assessed weekly first 30 days)The time to patient toxicity of drug combination bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan defined in days from baseline measure to occurence of adverse events grade 4 (life threatening or disabling) according to National Cancer Institute Common Toxicity Criteria (CTC), version 3.
Outcome measures
Outcome data not reported
Adverse Events
No Bortezomib
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Bortezomib 1.0 mg/m^2
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Bortezomib 1.5 mg/m^2
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
No Bortezomib
n=20 participants at risk
Melphalan 100 mg/m\^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
|
Bortezomib 1.0 mg/m^2
n=20 participants at risk
Bortezomib (Level 1) 1.0 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m\^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
|
Bortezomib 1.5 mg/m^2
n=20 participants at risk
Bortezomib (Level 2) 1.5 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
|
|---|---|---|---|
|
Infections and infestations
pneumonitis/death
|
5.0%
1/20 • Number of events 1 • Study period 2 years.
|
0.00%
0/20 • Study period 2 years.
|
0.00%
0/20 • Study period 2 years.
|
|
Renal and urinary disorders
acute renal failure
|
5.0%
1/20 • Number of events 1 • Study period 2 years.
|
0.00%
0/20 • Study period 2 years.
|
0.00%
0/20 • Study period 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
5.0%
1/20 • Number of events 1 • Study period 2 years.
|
0.00%
0/20 • Study period 2 years.
|
0.00%
0/20 • Study period 2 years.
|
|
Infections and infestations
pneumonia
|
0.00%
0/20 • Study period 2 years.
|
5.0%
1/20 • Number of events 1 • Study period 2 years.
|
0.00%
0/20 • Study period 2 years.
|
|
Cardiac disorders
ventriculat tachycardia/hypotension
|
0.00%
0/20 • Study period 2 years.
|
5.0%
1/20 • Number of events 1 • Study period 2 years.
|
0.00%
0/20 • Study period 2 years.
|
|
Gastrointestinal disorders
small bowel obstruction
|
0.00%
0/20 • Study period 2 years.
|
0.00%
0/20 • Study period 2 years.
|
5.0%
1/20 • Number of events 1 • Study period 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolus
|
0.00%
0/20 • Study period 2 years.
|
0.00%
0/20 • Study period 2 years.
|
5.0%
1/20 • Number of events 1 • Study period 2 years.
|
Other adverse events
| Measure |
No Bortezomib
n=20 participants at risk
Melphalan 100 mg/m\^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
|
Bortezomib 1.0 mg/m^2
n=20 participants at risk
Bortezomib (Level 1) 1.0 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m\^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
|
Bortezomib 1.5 mg/m^2
n=20 participants at risk
Bortezomib (Level 2) 1.5 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
|
|---|---|---|---|
|
Gastrointestinal disorders
mucositis
|
15.0%
3/20 • Number of events 3 • Study period 2 years.
|
15.0%
3/20 • Number of events 3 • Study period 2 years.
|
5.0%
1/20 • Number of events 1 • Study period 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
5.0%
1/20 • Number of events 1 • Study period 2 years.
|
0.00%
0/20 • Study period 2 years.
|
0.00%
0/20 • Study period 2 years.
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/20 • Study period 2 years.
|
5.0%
1/20 • Number of events 1 • Study period 2 years.
|
0.00%
0/20 • Study period 2 years.
|
|
Renal and urinary disorders
hydronephrosis
|
0.00%
0/20 • Study period 2 years.
|
5.0%
1/20 • Number of events 1 • Study period 2 years.
|
0.00%
0/20 • Study period 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary edema
|
0.00%
0/20 • Study period 2 years.
|
0.00%
0/20 • Study period 2 years.
|
10.0%
2/20 • Number of events 2 • Study period 2 years.
|
|
General disorders
low back pain
|
0.00%
0/20 • Study period 2 years.
|
0.00%
0/20 • Study period 2 years.
|
5.0%
1/20 • Number of events 1 • Study period 2 years.
|
|
Hepatobiliary disorders
elevated transaminases
|
0.00%
0/20 • Study period 2 years.
|
0.00%
0/20 • Study period 2 years.
|
5.0%
1/20 • Number of events 1 • Study period 2 years.
|
Additional Information
Muzaffar H. Qazilbash, MD/Professor, Stem Cell Transplantation
University of Texas M.D. Anderson Cancer Center
Phone: 713-745-3458
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place