Clinical trial · Interventional
Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma
NCT00602511CI-TRIAL-00004400completedPhase 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 purpose of the study is to compare thalidomide + dexamethasone with bortezomib + dexamethasone in patients with multiple myeloma refractory to melphalan therapy. The main goal is to find out which of these two 2:nd line regimens that offers the patients the best chance for a response with as long duration and as good quality of life as possible.
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 |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Bortezomib - dexamethasone
- interventionNames
- Drug: Bortezomib
- type
- EXPERIMENTAL
- label
- 2
- description
- Thalidomide - dexamethasone
- interventionNames
- Drug: Thalidomide
Primary outcomes (1)
- measure
- Progression free survival
Secondary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Treatment demanding multiple myeloma * Refractoriness to melphalan * Acceptance of rules for prevention of pregnancy Exclusion Criteria: * Previous treatment with bortezomib, thalidomide, or lenalidomide * Sensory neuropathy grade III or neuropathic pain grade II * Severe concomitant disorder, e.g. other malignancy or severe heart disease * Transformation to plasma cell leukemia or aggressive lymphoma * Frequent visits for bortezomib injections not feasible * Anticipated non-adherence to study protocol * Pregnancy * Anticipated non-adherence to rules for prevention of pregnancy * Severe thrombocytopenia (Thrombocyte count less than 25000/microliter)
References
Publications (0)
Data not yet available
No reference posted for this study.