Completed

Dexamethasone and Thalidomide Combination for Low-Risk Post Transplantation Relapse in Multiple Myeloma

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Study Aim

This study aims to evaluate the effectiveness of dexamethasone alone versus dexamethasone combined with thalidomide in treating low-risk multiple myeloma patients who have relapsed after an autologous transplant.

What is being tested

Thalidomide

+ Dexamethasone

Drug
Who is being recruted

Blood Protein Disorders+12

+ Cardiovascular Diseases

+ Hematologic Diseases

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 1998
See protocol details

Summary

Principal SponsorUniversity of Arkansas
Last updated: July 2, 2010
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 1998

Actual date on which the first participant was enrolled.

Maintenance Dexamethasone 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 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.

NCT00083902
Principal SponsorUniversity of Arkansas
Last updated: July 2, 2010
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

190 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Protein DisordersCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersImmune System DiseasesImmunoproliferative DisordersLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeParaproteinemiasVascular DiseasesHemostatic DisordersMultiple MyelomaNeoplasms, Plasma Cell

Criteria

6 inclusion criteria required to participate
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 be off chemotherapy (including steroids) and local radiotherapy for > or equal 3 weeks prior to entering the study
Patients must have a SWOG performance status of 0-2
Show More Criteria
2 exclusion criteria prevent from participating
No other concurrent therapy for myeloma is permitted while on protocol
There must be no evidence of active infection requiring IV antibiotics

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Arkansas for Medical Sciences/MIRT

Little Rock, United StatesOpen University of Arkansas for Medical Sciences/MIRT in Google Maps
CompletedOne Study Center