Arsenic Trioxide and Thalidomide in the Treatment of Refractory Multiple Myeloma

NCT00193544 | Completed Phase 2

• 1 other identifier: SCRI MM 03
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Overall response rate

Secondary Outcomes (3)

• Overall survival

• Time to progression

• Overall toxicity

Interventions

Arsenic Trioxide DRUG

Thalidomide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• CTI BioPharma: collaborator

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Arsenic Trioxide; Thalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• John D. Hainsworth, MD

  SCRI Development Innovations, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: March 1, 2002
• Primary Completion: October 1, 2005
• Study Completion: January 1, 2009
• Last Updated: January 23, 2009

Record last verified: 2009-01