Clinical trial · Interventional
Assessment of Molecular Remission by ASO-qPCR After Bortezomib-dexamethasone (Vel/Dex) Followed by ASCT
Assessment of Molecular Remission by ASO-RQ-PCR Technique After Induction Treatment With Bortezomib-dexamethasone (Vel/Dex) Followed by HDT With ASCT
NCT00861250CI-TRIAL-00022619completedPhase 2 / Phase 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 primary objective of this study is to determine the rate of molecular remissions (MolR) assessed by ASO-RQ-PCR technique after induction treatment with bortezomib and dexamethasone (Vel/Dex) prior to high-dose therapy with melphalan and autologous stem cell transplantation (HDT-ASCT), and after HDT-ASCT in patients with 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 |
|---|---|---|---|
| bortezomib + dexamethasone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vel/Dex
- interventionNames
- Drug: bortezomib + dexamethasone
Primary outcomes (1)
- measure
- Molecular remission after Vel/Dex induction (4 cycles) and 3-4 months after ASCT in those patients receiving CR or nCR
- timeFrame
- Before ASCT and 3-4 months after ASCT and then with 3-4 months interval
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Symptomatic multiple myeloma * Age 18-65 years * Written informed consent Exclusion Criteria: * WHO performance status ≥ 2, unless related to MM * Severe cardiac dysfunction * History of hypotension * Serious medical or psychiatric illness * Severe hepatic dysfunction * Severe polyneuropathy ≥ grade 2 * Active, uncontrolled infection * Previously treated with chemotherapy or extensive radiotherapy for MM * Known HIV positivity * Severe renal dysfunction with need of dialyses * History of active cancer during past 5 years, except non-melanoma skin cancer or stage 0 cervical cancer * Female patients who are pregnant or nursing * Male or female patients of reproductive potential who are not practising effective means of contraception
References
Publications (0)
Data not yet available
No reference posted for this study.