Dexamethasone or Dexamethasone in Combination With Thalidomide as Salvage Therapy

NCT00083902 | Completed Phase 2

• 1 other identifier: UARK 98-025
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this investigational trial is to find out how well patients respond and how long their response lasts when treated with a standard regimen of dexamethasone with or without thalidomide and also find out what kind of side effects patients will experience.

Conditions

Multiple Myeloma

Keywords

Myeloma; Thalidomide; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• To evaluate the effectiveness of dexamethasone (dex) alone as compared to dex in combination with thalidomide in low risk patients relapsing after autologous transplantation.

Secondary Outcomes (1)

• To evaluate the quantitative and qualitative toxicities associated with the regimens.

Interventions

Thalidomide DRUG

Dexamethasone DRUG

Eligibility Criteria

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

You may qualify if:

• All patients must have a confirmed diagnosis of previously treated, active multiple myeloma, with hypoproliferative/low risk relapse following at least one autologous transplant.
• Patients must be 18 years of age or older. Women of childbearing age and fertile men must use a medically acceptable means of birth control while on study and for 6 months thereafter.
• Patients must sign an informed consent to participate in this study, and be fully aware of the known teratogenic potential of this drug combination.
• Patients must have a SWOG performance status of 0-2.
• Patients must have adequate renal function, as defined by serum creatinine \< or = 3.0 mg/dl.
• Patients must be off chemotherapy (including steroids) and local radiotherapy for \> or equal 3 weeks prior to entering the study.

You may not qualify if:

• No other concurrent therapy for myeloma is permitted while on protocol.
• There must be no evidence of active infection requiring IV antibiotics.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences/MIRT

Little Rock, Arkansas, 72205, United States

Location

Related Links

• Myeloma Institute for Research \& Therapy website

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Thalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

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)

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; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Maurizio Zangari, M.D.

  UAMS

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 3, 2004
• First Posted: June 4, 2004
• Study Start: June 1, 1998
• Study Completion: May 1, 2005
• Last Updated: July 2, 2010

Record last verified: 2010-07

Locations

US (1)