Clinical trial · Observational
Evaluation of Maintenance With Bortezomib Plus Daratumumab (V-Dara) After Induction With Bortezomib, Melphalan, Prednisone Plus Daratumumab (VMP-Dara) in Newly Diagnosed Multiple Myeloma (MM) Patients Non-eligible for autoSCT
A Prospective, Observational Study, to Evaluate the Maintenance With Bortezomib Plus Daratumumab (V-Dara) After Induction With Bortezomib, Melphalan, Prednisone Plus Daratumumab (VMP-Dara) in Newly Diagnosed Multiple Myeloma (MM) Patients Non-eligible for Autologous Stem Cell Transplantation (ASCT): Alcyone-optimized Real World Evidence (RWE) Data
- 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)
This is a prospective, observational, single group and multicenter study to describe the effectiveness and safety of maintenance with V-Dara after induction with the VMP-Dara regimen in newly diagnosed MM patients who are not eligible for ASCT. Patients will be enrolled in the study during a regularly scheduled office visit in clinical practice (screening and enrollment visit) and followed during 3-4 years in what will be called the Observational Phase. During this phase, the patient will be followed by his/her doctor as per routine clinical practice, according to his/her disease. The patient will not suffer any changes in his/her treatment or follow-up due to his/her participation in the study. The patient will receive standard clinical practice and he/she will not do any other study-specific visit. During this 3-4-year observational phase, the patient might discontinue V or V-Dara,depending on toxicity, efficacy or due to other medical reasons, according to his/her physician decision.
Conditions
Conditions (2)
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 |
| Non-eligible for Autologous Stem Cell Transplantation (ASCT) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Daratumumab | Drug | Daratumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Maintenance with V-Dara after receiving VMP-Dara as induction regimen
- description
- Maintenance with bortezomib plus daratumumab (V-Dara) after induction with bortezomib, melphalan, prednisone plus daratumumab (VMP-Dara)
- interventionNames
- Drug: Bortezomib
- Drug: Daratumumab
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- Throughout the study period. Approximately 4 years
- description
- Time from the start of induction with VMPDara until disease progression or death, whichever comes first
Secondary outcomes (8)
- measure
- Description of MRD status and depth
- timeFrame
- Throughout the study period. Approximately 4 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with a newly diagnosed MM non eligible for ASCT that have received induction therapy with D-VMP (9 cycles) and followed by V-Dara as maintenance\* in clinical practice. The decision to prescribe maintenance treatment with V-Dara must be in accordance with clinical practice, must not be influenced by the planned inclusion of a patient in the study, and should be documented before enrollment. 2. Patients ≥18 years of age. 3. Each subject (or their legally acceptable representative) must sign the ICF indicating that he or she understands the purpose of the observational nature the study and are willing to share his/her clinical data for the study. Exclusion Criteria: 1. Patients with a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, smoldering MM, plasma cell leukemia, POEMS syndrome, Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions. 2. Subjects with prior or current systemic therapy or ASCT for MM (before VMP-Dara induction), except for an emergency use of a short course of corticosteroids before treatment.
References
Publications (36)
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- BACKGROUNDBianchi G, Richardson PG, Anderson KC. Promising therapies in multiple myeloma. Blood. 2015 Jul 16;126(3):300-10. doi: 10.1182/blood-2015-03-575365. Epub 2015 Jun 1. No abstract available. PMID 26031917
- BACKGROUNDAnderson KC. Progress and Paradigms in Multiple Myeloma. Clin Cancer Res. 2016 Nov 15;22(22):5419-5427. doi: 10.1158/1078-0432.CCR-16-0625. PMID 28151709
- BACKGROUNDKumar SK, Rajkumar V, Kyle RA, van Duin M, Sonneveld P, Mateos MV, Gay F, Anderson KC. Multiple myeloma. Nat Rev Dis Primers. 2017 Jul 20;3:17046. doi: 10.1038/nrdp.2017.46. PMID 28726797
- BACKGROUNDMihelic R, Kaufman JL, Lonial S. Maintenance therapy in multiple myeloma. Leukemia. 2007 Jun;21(6):1150-7. doi: 10.1038/sj.leu.2404633. Epub 2007 Mar 8. PMID 17344913
- BACKGROUNDLudwig H, Durie BG, McCarthy P, Palumbo A, San Miguel J, Barlogie B, Morgan G, Sonneveld P, Spencer A, Andersen KC, Facon T, Stewart KA, Einsele H, Mateos MV, Wijermans P, Waage A, Beksac M, Richardson PG, Hulin C, Niesvizky R, Lokhorst H, Landgren O, Bergsagel PL, Orlowski R, Hinke A, Cavo M, Attal M; International Myeloma Working Group. IMWG consensus on maintenance therapy in multiple myeloma. Blood. 2012 Mar 29;119(13):3003-15. doi: 10.1182/blood-2011-11-374249. Epub 2012 Jan 23.