Clinical trial · Interventional
PAD Combination Therapy Followed by Thal/Dex for Relapsed or Refractory Multiple Myeloma
PS-341 (Bortezomib, Velcade®), Adriamycin and Dexamethasone (PAD) Combination Therapy Followed by Thalidomide With Dexamethasone (Thal/Dex) for Relapsed or Refractory Multiple Myeloma
NCT00319865CI-TRIAL-00000328unknownPhase 2ClinicalTrials.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)
Prospective multicenter phase 2 study using PAD and Thal/Dex combination sequentially.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adriamycin | Drug | — | UNRESOLVED |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Thalidomide | Drug | Thalidomide | ALIAS |
| Velcade | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate of PAD induction Therapy
Secondary outcomes (3)
- measure
- Response rate of PAD followed by Thal/Dex maintenance
- measure
- Progression free survival and Overall survival of PAD/Thal-Dex.
- measure
- To evaluate toxicities of PAD/Thal-Dex
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with multiple myeloma who relapsed after at least 1 lines of therapy including high dose thearapy with autologous stem cell transplantation and chemotherapy. * Presence of measureble disease : serum M-protein \> 1g/dL or urine M-protein \> 400mg/day * Age \< 75 * Performance status \</= ECOG 2 * Expected survival \> 6 months * who signs the informed consent Exclusion Criteria: * known hypersensitivity to thalidomide or dexamethasone * known refractoriness to thalidomide + dexamethasone * Previous Velcade therapy * Sepsis * Woman in reproductive age * Serum creatinine \> 2 mg/dL ; 24 hour creatinine clearance \< 30 ml/min; past medical history of kidney transplatation * Peripheral neuropathy \>/= grade 2 * Recurrent DVT or pulmonary embolism * Cardiac ejection fraction \<0.5 : Severe conduction disorder * Hepatic dysfunction (AST or ALT ≥ x 5 upper normal) or active hepatitis * Active ulcers in gastrofiberscope
References
Publications (0)
Data not yet available
No reference posted for this study.