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CompletedNCT00193544Updated Jan 23, 2009

Arsenic Trioxide and Thalidomide in the Treatment of Refractory Multiple Myeloma

A Phase 2 interventional study of Arsenic Trioxide and Thalidomide in Multiple Myeloma, sponsored by SCRI Development Innovations, LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-01-23.

Sponsored by SCRI Development Innovations, LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

In this trial, we plan to evaluate further the role of arsenic trioxide in the treatment of patients with refractory multiple myeloma. Arsenic trioxide will be used in combination with thalidomide. Although both drugs have a similar mechanism of action, it is likely that the mechanisms may be additive or synergistic. Since neither drug produces much myelosuppression, this combination regimen should be tolerable in patients with compromised marrow function due to involvement with myeloma and/or previous cytotoxic chemotherapy

Read the detailed description

Upon determination of eligibility, patients will be receive:

  • Arsenic Trioxide + Thalidomide
02

Conditions studied

03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 40 is close to the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

SCRI Development Innovations, LLC is the lead sponsor of 174 studies on the registry; 5 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 15 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

To be included in this study, you must meet the following criteria:

  • Confirmed diagnosis of multiple Myeloma
  • Received at least one previous chemotherapy regimen at most 3 previous
  • Thalidomide with or without dexamethasone without chemotherapy will not factor in to total number of regimens.
  • Age at least 18 years years
  • Able to perform activities of daily living with minimal assistance
  • Life expectancy more than 3 months
  • Adequate bone marrow, liver and kidney function
  • Must give written informed consent in order to participate.

Exclusion criteria

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

  • Women pregnant or lactating.
  • Pre-existing moderate neuropathy
  • Patients with significant underlying cardiac dysfunction
  • Uncontrolled hypercalcemia
  • Active serious infections not controlled by antibiotics
  • History of grand mal seizures (other than infantile febrile seizures)
  • Receiving other medications that prolong the QT interval.

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants

Interventions

  • DrugArsenic Trioxide
  • DrugThalidomide
06

What researchers measure

Primary outcomes

  1. Overall response rate

Secondary outcomes

  1. Overall survival

  2. Time to progression

  3. Overall toxicity

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00193544
Lead sponsor
SCRI Development Innovations, LLC
Collaborators
CTI BioPharma
First posted
Sep 19, 2005
Start date
Mar 2002
Primary completion
Oct 2005
Completion
Jan 2009
Last update
Jan 23, 2009

Study contacts

John D. Hainsworth, MD
principal investigator · SCRI Development Innovations, LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

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