Clinical trial · Interventional
Arsenic Trioxide With Ascorbic Acid and Melphalan for Myeloma Patients
Phase I/II Study of the Combination of Arsenic Trioxide With Ascorbic Acid and High-Dose Melphalan for Patients With Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Stem Cell Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arsenic Trioxide | Drug | Arsenic Trioxide | ALIAS |
| Ascorbic Acid | Drug | — | UNRESOLVED |
| Melphalan | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arsenic Trioxide + Vitamin C + Melphalan
- description
- Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0)
- interventionNames
- Drug: Arsenic Trioxide
- Drug: Melphalan
- Drug: Ascorbic Acid
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- 3, 6 and 12 months
- description
- Bone marrow aspirate and biopsy performed to assess complete response and overall response rate.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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 . 2. Age up to 70 years. 3. Zubrod Performance Status (PS) of \<2. 4. Left ventricular ejection fraction \>40%. No uncontrolled arrhythmias or symptomatic cardiac disease. 5. 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. 6. Serum bilirubin \<2 times upper limit of normal, SGPT \<4 times upper limit of normal. No evidence of chronic active hepatitis or cirrhosis. No effusion or ascites \>1L prior to drainage. 7. HIV-negative. 8. Patient is not pregnant. 9. Patient or guardian able to sign informed consent. 10. Corrected QT interval less than 500 msec. Exclusion Criteria: 1. Corrected QT interval greater than 500 msec 2. 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). 3. Patients with non-secretory myeloma.
References
Publications (0)
Data not yet available