Arsenic Trioxide and Thalidomide in the Treatment of Refractory Multiple Myeloma

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: Arsenic Trioxide

Drug: Thalidomide

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00193544

SCRI MM 03

Details and patient eligibility

About

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

Full description

Upon determination of eligibility, patients will be receive:

Arsenic Trioxide + Thalidomide

Sex

All

Ages

18+ years old

Volunteers

No 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/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.