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Dexamethasone or Dexamethasone in Combination With Thalidomide as Salvage Therapy

This study has been completed.
Information provided by:
University of Arkansas Identifier:
First received: June 3, 2004
Last updated: July 1, 2010
Last verified: July 2010
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.

Condition Intervention Phase
Multiple Myeloma
Drug: Thalidomide
Drug: Dexamethasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: UARK 98-025, A Randomized Phase II Trial of Dexamethasone or Dexamethasone in Combination With Thalidomide as Salvage Therapy for Low-Risk Post Transplantation Relapse in Patients With Multiple Myeloma

Resource links provided by NLM:

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • To evaluate the quantitative and qualitative toxicities associated with the regimens.

Estimated Enrollment: 190
Study Start Date: June 1998
Estimated Study Completion Date: May 2005
Detailed Description:



Patients will receive 40 mg dexamethasone days 1-4 only, every 3-4 weeks. Response will be assessed at least every 3 months while on maintenance therapy. Appropriate H2 blocker and antibiotics will also be given.


Thalidomide will continue at a dose of 400 mg daily, or at the dose that was reduced and judged to be well tolerated in induction therapy. Thalidomide will be given as an oral, once daily dose at bedtime. Those patients unable to tolerate dexamethasone may continue on thalidomide alone until criteria for removal from treatment is met.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • No other concurrent therapy for myeloma is permitted while on protocol.
  • There must be no evidence of active infection requiring IV antibiotics.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00083902

United States, Arkansas
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Principal Investigator: Maurizio Zangari, M.D. UAMS
  More Information

Additional Information: Identifier: NCT00083902     History of Changes
Other Study ID Numbers: UARK 98-025 
Study First Received: June 3, 2004
Last Updated: July 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Arkansas:

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on October 27, 2016