Thalidomide-Dexamethasone for Multiple Myeloma

NCT00038090 | Completed Phase 2

• 1 other identifier: ID00-070
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Myeloma

Keywords

Myeloma; Thalidomide; Thalomid; Dexamethasone; Decadron

Outcome Measures

Primary Outcomes (1)

• Response Rate

  Baseline, with each course and monthly tests

Study Arms (1)

Thalidomide + Dexamethasone

EXPERIMENTAL

Drug: Thalidomide; Drug: Dexamethasone

Interventions

Thalidomide DRUG

100 mg capsules by mouth daily each evening

Also known as: Thalomid

Thalidomide + Dexamethasone

Dexamethasone DRUG

20 mg/m\^2 taken by mouth each morning on days 1-4, 9-12 and 17-20.

Also known as: Decadron

Thalidomide + Dexamethasone

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Celgene Corporation: collaborator

Study Sites (1)

University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Thalidomide; Dexamethasone; Calcium Dobesilate

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; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Donna M Weber, M.D.

  UT MD Anderson Cancer Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: May 28, 2002
• First Posted: May 29, 2002
• Study Start: June 1, 2000
• Primary Completion: May 1, 2005
• Study Completion: May 1, 2005
• Last Updated: October 31, 2018

Record last verified: 2018-10

Locations

US (1)