Arsenic Trioxide and Thalidomide in the Treatment of Refractory Multiple Myeloma

Phase II Trial of Arsenic Trioxide and Thalidomide in the Treatment of Patients With Refractory Multiple Myeloma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00193544

Enrollment

Registered

2005-09-19

Start date

2002-03-31

Completion date

2009-01-31

Last updated

2009-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Brief 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

Detailed description

Upon determination of eligibility, patients will be receive: * Arsenic Trioxide + Thalidomide

Interventions

DRUGArsenic Trioxide

DRUGThalidomide

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

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/

Design outcomes

Primary

Measure	Time frame
Overall response rate	—

Secondary

Measure	Time frame
Overall survival	—
Time to progression	—
Overall toxicity	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026