CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Arsenic Trioxide +2 moredrug
Likely dose
Arsenic Trioxide 0.15 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00661544
NCT00661544Phase 2Completed
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Phase I/II Study of the Combination of Arsenic Trioxide With Ascorbic Acid and High-Dose Melphalan for Patients With Multiple Myeloma

M.D. Anderson Cancer Center·interventional·Posted Apr 18, 2008·Updated Mar 4, 2013

In Brief

A Phase 2 clinical trial evaluating Arsenic Trioxide, Melphalan, and 1 other intervention for Multiple Myeloma and Stem Cell Transplantation. Completed, enrolled 48 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma, Stem Cell Transplantation
CountriesUnited States
CollaboratorsCTI BioPharma

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 18, 2008
Enrollment StartMar 1, 2004
Primary CompletionJun 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.2 years ago

Interventions

Arsenic Trioxidedrug

Dose Level 1: None; Dose Level 2: 0.15 mg/kg days Intravenous (IV) Days -9 to -3; Dose Level 3: 0.25 mg/kg days IV Days -9 to -3.

Melphalandrug

Dose Levels 1, 2, \& 3: 100 mg/m2 IV Days -4, -3.

Ascorbic Aciddrug

Dose Levels 1, 2, \& 3: 1000 mg IV Days -9 to -3.