Clinical trial · Interventional
Thalidomide for Multiple Myeloma
NCT00038233CI-TRIAL-00035548completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this protocol is to assess therapeutic activity of thalidomide in previously untreated patients with asymptomatic multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Thalidomide
- description
- 200 mg at bedtime daily for 14 days (days 1-14), followed by an increase to 400 mg daily for 14 days (days 15-28), 600 mg daily for 14 days (days 29-42), up to a maximum 800 mg (days 43-completion)
- interventionNames
- Drug: Thalidomide
Primary outcomes (1)
- measure
- Maximum Tolerated Dose of Thalidomide
- timeFrame
- 14 day cycles
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
* Previously untreated patients with multiple myeloma and without serious or imminent complications (e.g. impending pathologic fracture, hypercalcemia, renal insufficiency). All asymptomatic patients with low or intermediate tumor mass will qualify. * Patients with high tumor mass, symptomatic or impending fractures, hypercalcemia (corrected calcium \>11.5 mg%), anemia (Hgb \<8.5 gm/dl), renal failure (creatinine \>2.0 mg/dl), high serum lactate dehydrogenase (\>300 U/L) or plasma cell leukemia (\>1000/ul) are ineligible. * Overt infections or unexplained fever should be resolved before treatment. Adequate liver function (including SGPT, bilirubin and LDH) is required. * Patients must have Zubrod performance of 1 or less. * Patients must provide written informed consent indicating that they are aware of the investigational nature of this study. * Life expectancy should exceed 1 year. * Patients with idiopathic monoclonal gammopathy and non-secretory multiple myeloma are ineligible. Patients whose only prior therapy has been with local radiotherapy, alpha-IFN, or ATRA are eligible. Patients exposed to prior high-dose glucocorticoid or alkylating agent are not eligible.
References
Publications (0)
Data not yet available
No reference posted for this study.