Clinical trial · Observational
Observational Study to Evaluate the Efficacy and Safety of Bortezomib, Melphalan, Prednisone (VMP) in Participants With Multiple Myeloma
A Prospective, Open-label, Multicenter, Observational Study to Evaluate the Efficacy and Safety of Bortezomib, Melphalan, Prednisone(VMP) for Initial Treatment in Patients With Multiple Myeloma Who do Not Undergo Autologous Stem Cell Transplantation
NCT02474563CI-TRIAL-00018401completedClinicalTrials.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 this study is to assess the 2-year progression-free survival rate.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Bortezomib, Melphalan, Prednisone (VMP) Group
- description
- Participants will not receive any intervention in this study. Participants receiving VMP therapy for MM that was not eligible for autologous stem cell transplantation will be enrolled in the study.
- interventionNames
- Drug: Bortezomib
- Drug: Melphalan
- Drug: Prednisone
Primary outcomes (1)
- measure
- 2-year Progression-free Survival Rate
- timeFrame
- Up to 2 years
- description
- Progression-free survival rate: the length of time from the day when Bortezomib was first administered to disease progression or death, whichever comes first, in 2 years.
Secondary outcomes (5)
- measure
- Time to Response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Participants who are naïve to chemotherapy for multiple myeloma and not eligible for autologous stem cell transplantation * Participants with symptomatic multiple myeloma: a) Intramedullary monoclonal plasma cells greater than or equal to (\>=) 10% or histologically confirmed plasmacytoma; b) Presence of monoclonal protein in the serum or urine; c) Myeloma-related organ impairment as defined in protocol * Participants with presence of an illness that is detectable by definitions as defined in protocol * Postmenopausal, sterilized or sexually inactive women, including women of childbearing potential who exercise effective contraceptive measures before and during the clinical trial Exclusion Criteria: * Participants with previous experience of receiving a therapy for multiple myeloma (excluding radiotherapy and dexamethasone \< 160mg in total) * Participants with severe peripheral neuropathy (Grade \>= 2 by NCI CTC version 4.0) * Pregnant or breastfeeding mothers * Participants with mental illness that can interfere with his/her cooperation with the therapy or the monitoring conditions of the clinical trial * Participants with other serious medical conditions (such as uncontrolled hypertension, diabetes mellitus and active infections)
References
Publications (0)
Data not yet available
No reference posted for this study.