Clinical trial · Interventional
Bortezomib/Adriamycine/Melfalan/Prednisone (VAMP)/Thalidomide/Cyclophosphamide/Dexamethasone (TaCyDex) or Bortezomib/Melfalan/Prednisone (V-MP)/TaCyDex) in Refractary or Relapsed Multiple Myeloma
Thalidomide-Cyclophosphamide-Dexamethasone in Patients < 75 Years or Velcade-Melfalan-Prednisone (V-MP)/Thalidomide-Cyclophosphamide-Dexamethasone in Patients >75 Years, in Refractary or Relapsed Multiple Myeloma
- 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)
Multicentric study, open, single arm, designed to evaluate the efficacy(response rate and response duration) and security of a sequential scheme of treatment with Bortezomib in combination with Melfalan and Prednisone (V-MP) (patients \> 75 years) or Bortezomib and Adriamycine in combination with Melfalan and Prednisone (VAMP) (patients \<= 75 years) follow by Thalidomide in combination with Cyclophosphamide and Dexamethasone (TaCyDex) in patients with refractary or relapse 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Induction: 6 alternating cycles Bortezomib-Melfalan-Prednisone or Bortezomib- Adriamycine-Melfalan-Prednisone and Thalidomide-Cyclophosphamide-Dexamethasone, followed by other 6 maintenance cycles
- interventionNames
- Drug: Bortezomib
- Drug: Thalidomide
Primary outcomes (1)
- measure
- Efficacy of a sequential scheme treatment with Bortezomib, Melfalan,Prednisone (V-MP) or Bortezomib, Adriamycine, Melfalan,Prednisone (VAMP) followed by Thalidomide, Cyclophosphamide and Dexamethasone (TaCyDex) in relapsed or refractory MM patients
- timeFrame
- 1 year
Secondary outcomes (2)
- measure
- Evaluate the response type in function to different initial situation (primary resistance, relapse, progression)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with refractary or relapsed multiple myeloma * ECOG ≤ 3 * Life expectancy \> 3 months * Neutrophils account ≥ 0.5 X 10\^9/L, platelets ≥ 30 X 10\^9/L. * Transaminases \<3 times upper normal limit, bilirubin \< 2 times upper normal limit * Age \> 18 years * Time after last chemotherapy or radiotherapy \> 1 month or time after transplantation \> 2 months. * No possible other actual treatment * Written consent form Exclusion Criteria: * Candidate to second transplantation * No following criteria * Other neoplasties * Peripheral neuropathy \> Grade 2. * Previous ileus paralytic * Hepatic failure * No controlled infection * No controlled high calcium levels * Any organic insufficiency that no permit follow the correct treatment * Pregnancy, breast feeding or fertility without anticonceptive method * Any psychological, social and/or familiar event that no permit follow the correct treatment * Diabetes mellitus not controled
References
Publications (0)
Data not yet available