Clinical trial · Interventional
Thalidomide Plus Dexamethasone as Maintenance Therapy for Multiple Myeloma
Thalidomide Plus Dexamethasone as Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma: a Multicenter Phase 3 Randomized Trial
NCT01296503CI-TRIAL-00004418completedPhase 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)
This multicenter, prospective, randomized trial was designed to evaluate the role of thalidomide with or without dexamethasone as a maintenance therapy for multiple myeloma patients after a single autologous stem cell transplantation.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Thalidomide plus dexamethasone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Dexamethasone (Arm A)
- description
- Sixty days (D+60) after ASCT: randomization in two arms of maintenance: Arm A (dexamethasone alone 40 mg/day for 4 days every 28 days)
- interventionNames
- Drug: Dexamethasone
- type
- EXPERIMENTAL
- label
- Thalidomide and Dexamethasone (Arm B)
- description
- D+60 after ASCT: dexamethasone plus thalidomide 200 mg by mouth daily for 12 months or until disease progression. The dose of thalidomide could be reduced if the patient experienced grade 2 or higher adverse events. In this case, thalidomide was discontinued and re-challenged at a lower dose after resolution of the adverse event.
- interventionNames
- Drug: Thalidomide plus dexamethasone
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * symptomatic multiple myeloma in accordance with the International Myeloma Working Group criteria; * age 18-70 years; * Performance status 0-2 by the Eastern Cooperative Oncology Group (ECOG) criteria; * normal hepatic function, defined as serum bilirubin \<3 mg/dl and alanine aminotransferase(ALT) and asparagin aminotransferase (AST) \<4x normal. Exclusion Criteria: * evidence of disease progression after ASCT; * cardiac dysfunction (systolic ejection fraction \<50%); * chronic respiratory disease (carbon monoxide diffusion \<50% of normal).
References
Publications (0)
Data not yet available
No reference posted for this study.