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Thalidomide-Dexamethasone for Multiple Myeloma

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00038090
First received: May 28, 2002
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

Objective is to assess the activity of the combination of thalidomide and dexamethasone in patients with previously untreated multiple myeloma.


Condition Intervention Phase
Multiple Myeloma
Drug: Thalidomide
Drug: Dexamethasone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Thalidomide-Dexamethasone for Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Response Rate [ Time Frame: Baseline, with each course and monthly tests ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: September 2001
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thalidomide + Dexamethasone Drug: Thalidomide
100 mg capsules by mouth daily each evening
Other Name: Thalomid
Drug: Dexamethasone
20 mg/m^2 taken by mouth each morning on days 1-4, 9-12 and 17-20.
Other Name: Decadron

Detailed Description:

This study will examine the potential efficacy of thalidomide-dexamethasone in the treatment of patients with previously untreated multiple myeloma.

  • Thalidomide is supplied as 50 mg capsules to be taken by mouth.
  • Thalidomide 200 mg daily each evening at bedtime increasing by 100-200 mg increments (according to patient tolerability) every 4 weeks.

For elderly patients, or those with poor performance status or comorbid conditions which may affect tolerance of the thalidomide-dexamethasone combination, the initial dose may be reduced by 50-100 mg decrements and escalated weekly by 50-100 mg increments to tolerance. For patients who experience significant toxicity (> grade 2) or are otherwise unable to tolerate this drug combination, the dose will be reduced by 50-100 mg decrements. For some patients with > grade 2 toxicity, it may be necessary to hold the thalidomide dose until improvement of the side effect with subsequent resumption of the dose after dose reduction as outlined above.

Dexamethasone 20mg/m2 each morning after breakfast on days 1-4, 9-12, 17-20, with a repeat cycle after a 1-2 week rest period. In case of partial remission, maintenance treatment with thalidomide alone will be continued for as long as remission is sustained at a dose free of side effects.

For patients achieving CR, consolidation with thalidomide-dexamethasone for 4-6 months followed by follow-up without maintenance treatment. No maximum trial period is planned.

At relapse patients may be reinitiated on the original thalidomide-pulse dexamethasone program and responding patients may be maintained on thalidomide alone (CR) or daily thalidomide and dexamethasone (days 1-4) until relapse.

Patients who experience significant toxicity (grade 2 or more) at any time during therapy will receive a lower dose after treatment is interrupted.

In an attempt to avoid deep venous thrombosis, all patients for whom anticoagulation is not contraindicated will be offered therapeutic anticoagulation (INR 1.5-2.5) with coumadin or therapeutic doses of low molecular weight heparin.

Patients must be willing to return for evaluation every 4 weeks since thalidomide may only be prescribed for 28 day intervals.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Previously untreated patients with symptomatic or progressive asymptomatic multiple myeloma. Criteria for progression among patients with asymptomatic disease include new lytic bone lesions, rise of serum myeloma protein to >5.0 gm/dl or fall of Hgb to <10.5 gm/dl.
  • Overt infection or unexplained fever should be resolved before treatment or treated concurrently with antibiotics.
  • Patients must provide written informed consent indicating that they are aware of the investigational nature of this study.
  • Patients with idiopathic monoclonal gammopathy or stable asymptomatic myeloma are ineligible.
  • Patients whose only prior therapy has been with local radiotherapy or alpha interferon are eligible.
  • Patients treated with steroids in order to stabilize disease within 60 days prior to enrollment are eligible.
  • Patients exposed to longer periods of high-dose glucocorticoid, or with any exposure to thalidomide or alkylating agent are ineligible.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038090

Locations
United States, Texas
University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Investigators
Study Chair: Donna M Weber, M.D. UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038090     History of Changes
Other Study ID Numbers: ID00-070
Study First Received: May 28, 2002
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Myeloma
Thalidomide
Thalomid
Dexamethasone
Decadron

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014