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NCT05218603
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
trial testing Bortezomib in Multiple Myeloma in 100 participants. Status unknown.
6 November 2025
Quick facts
| Lead sponsor | PETHEMA Foundation |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 30 November 2021 |
| Primary completion | 6 November 2025 |
| Estimated completion | 6 November 2025 |
| Sites | 32 locations across Spain |
Drugs / interventions tested
- Bortezomib (bortezomib) — full drug profile →
- Daratumumab (daratumumab) — full drug profile →
Conditions studied
- Multiple Myeloma — all drugs for Multiple Myeloma →
- Non-eligible for Autologous Stem Cell Transplantation (ASCT) — all drugs for Non-eligible for Autologous Stem Cell Transplantation (ASCT) →
Sponsor
PETHEMA Foundation
Who can join
18 and older, any sex, with Multiple Myeloma or Non-eligible for Autologous Stem Cell Transplantation (ASCT). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The NF-κB Pharmacopeia: Novel Strategies to Subdue an Intractable Target.
Verzella D, Cornice J, Arboretto P, Vecchiotti D, et al · · 2022 · cited 23× · PMID 36140335 · DOI 10.3390/biomedicines10092233
Verify or expand the search:
- PubMed search for NCT05218603
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT07428369 — A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM) · Phase 2, PHASE3 · not yet recruiting
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Other recruiting trials for Multiple Myeloma
Currently open trials in the same condition.
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- NCT07266441 — A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma · Phase 2 · recruiting
- NCT07258511 — A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With · Phase 3 · recruiting
Other PETHEMA Foundation trials
Trials by the same sponsor.
- NCT07443592 — Treatment for Ph-negative ALL for Adults up to 65 Years · NA · not yet recruiting
- NCT07045909 — Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma (GEM-AnitoFIRST) · Phase 2 · recruiting
- NCT06574126 — Ciltacabtagene Autoleucel in High-Risk Smoldering Multiple Myeloma · Phase 2 · recruiting
- NCT06544785 — Zanubrutinib With Obinutuzumab in Untreated Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma · Phase 2 · recruiting
- NCT06175702 — Treatment Protocol for Newky Diagnosed Adult Ph Positive ALL · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05218603 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by PETHEMA Foundation
- Last refreshed: 16 September 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05218603.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing