Phase 2
N=48
Arsenic Trioxide With Ascorbic Acid and Melphalan for Myeloma Patients
Multiple Myeloma · Stem Cell Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00661544 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jul 2009
Primary outcome: Primary: Response Rate — 11; 36 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Arsenic Trioxide (Drug); Melphalan (Drug); Ascorbic Acid (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jun 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate |
11; 36 | — |
Summary
1. To evaluate the toxicity and safety of a combination of arsenic trioxide with ascorbic acid and high-dose Melphalan in patients with multiple myeloma
2. To evaluate the efficacy of a combination of arsenic trioxide with ascorbic acid and high-dose Melphalan in patients with multiple myeloma
3. To determine the effects of arsenic trioxide on melphalan pharmacokinetics
Eligibility Criteria
Inclusion Criteria
- Patients with Multiple Myeloma in any of the following disease categories: a) Primary Refractory Disease b) Consolidation of a partial remission (defined as a decrease but continued presence of monoclonal protein on serum and urine immunofixation electrophoresis, and/or the presence of plasmacytosis on bone marrow aspirate and biopsy) c) All patients relapsing after prior therapy .
- Age up to 70 years.
- Zubrod Performance Status (PS) of 40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Forced vital capacity (FVC); Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and Carbon Monoxide Diffusing Capacity (DL CO) >40%. No symptomatic pulmonary disease.
- Serum bilirubin 1L prior to drainage.
- HIV-negative.
- Patient is not pregnant.
- Patient or guardian able to sign informed consent.
- Corrected QT interval less than 500 msec.
Exclusion Criteria
- Corrected QT interval greater than 500 msec
- Patients in complete remission (defined as the absence of monoclonal protein on serum and urine immunofixation electrophoresis, and the absence of plasmacytosis in bone marrow aspirate and biopsy).
- Patients with non-secretory myeloma.
Data sourced from ClinicalTrials.gov (NCT00661544). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.