Thalidomide-Dexamethasone for Multiple Myeloma
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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 |
- 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 |
- 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| United States, Texas | |
| University of Texas M. D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| 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 Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Dexamethasone acetate |
Dexamethasone Dexamethasone 21-phosphate Thalidomide BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones |
ClinicalTrials.gov processed this record on May 23, 2013