Trial Outcomes & Findings for Arsenic Trioxide With Ascorbic Acid and Melphalan for Myeloma Patients (NCT NCT00661544)
NCT ID: NCT00661544
Last Updated: 2013-03-04
Results Overview
Bone marrow aspirate and biopsy performed to assess complete response and overall response rate.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
48 participants
Primary outcome timeframe
3, 6 and 12 months
Results posted on
2013-03-04
Participant Flow
Recruitment Period: 03/31/2004 through 08/02/2005. All pariticipants recruited at U.T. M.D. Anderson Cancer Center.
Participant milestones
| Measure |
Arsenic Trioxide + Vitamin C + Melphalan
Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Arsenic Trioxide With Ascorbic Acid and Melphalan for Myeloma Patients
Baseline characteristics by cohort
| Measure |
Arsenic Trioxide + Vitamin C + Melphalan
n=48 Participants
Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
|
|---|---|
|
Age, Customized
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3, 6 and 12 monthsBone marrow aspirate and biopsy performed to assess complete response and overall response rate.
Outcome measures
| Measure |
Arsenic Trioxide + Vitamin C + Melphalan
n=48 Participants
Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
|
|---|---|
|
Response Rate
Overall Response (Complete + Partial Response)
|
36 Participants
|
|
Response Rate
Complete Response
|
11 Participants
|
Adverse Events
Arsenic Trioxide + Vitamin C + Melphalan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Muzaffar H. Qazilbash, MD / Associate Professor
U.T. M.D. Anderson Cancer Center
Phone: 713-745-3458
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place