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NCT04287855
Multicenter Open Label Phase 2 Study of Isatuximab Plus Pomalidomide and Dexamethasone With Carfilzomib in Relapsed or Refractory Multiple Myeloma
Phase 2 trial testing Isatuximab in Multiple Myeloma in Relapse in 82 participants. Status unknown.
15 April 2025
Quick facts
| Lead sponsor | Poitiers University Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 82 |
| Start date | 28 August 2020 |
| Primary completion | 15 April 2025 |
| Estimated completion | 15 April 2026 |
| Sites | 1 location across France |
Drugs / interventions tested
- Isatuximab (isatuximab) — full drug profile →
- Carfilzomib (carfilzomib) — full drug profile →
- Pomalidomide — full drug profile →
- Dexamethasone (dexamethasone) — full drug profile →
Conditions studied
- Multiple Myeloma in Relapse — all drugs for Multiple Myeloma in Relapse →
- Multiple Myeloma, Refractory — all drugs for Multiple Myeloma, Refractory →
Sponsor
Poitiers University Hospital
Who can join
18 and older, any sex, with Multiple Myeloma in Relapse or Multiple Myeloma, Refractory. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Study a quadruplet-based regimen with Minimal Residual Disease (MRD) 10-5 negative rate as primary end point in patients with early Relapsed or Refractory Multiple Myeloma. Therapeutic study, phase II, prospective, multicenter, open-label. The patients will be treated until progression. Each cycle of treatment lasts 28 days. Cycle 1 to 13 : treatment phase After cycle 13 : maintenance phase
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Harnessing natural killer cells for cancer immunotherapy: dispatching the first responders.
Maskalenko NA, Zhigarev D, Campbell KS. · · 2022 · cited 174× · PMID 35314852 · DOI 10.1038/s41573-022-00413-7 -
Minimal Residual Disease in Multiple Myeloma: Current Landscape and Future Applications With Immunotherapeutic Approaches.
Kostopoulos IV, Ntanasis-Stathopoulos I, Gavriatopoulou M, Tsitsilonis OE, et al · · 2020 · cited 42× · PMID 32537439 · DOI 10.3389/fonc.2020.00860 -
Ikaros Proteins in Tumor: Current Perspectives and New Developments.
Xia R, Cheng Y, Han X, Wei Y, et al · · 2021 · cited 12× · PMID 34950704 · DOI 10.3389/fmolb.2021.788440 -
Pomalidomide- and dexamethasone-based regimens in the treatment of refractory/relapsed multiple myeloma.
Fotiou D, Gavriatopoulou M, Terpos E, Dimopoulos MA. · · 2022 · cited 11× · PMID 35585966 · DOI 10.1177/20406207221090089 -
Monoclonal Antibodies: Leading Actors in the Relapsed/Refractory Multiple Myeloma Treatment.
Morè S, Petrucci MT, Corvatta L, Fazio F, et al · · 2020 · cited 6× · PMID 33260960 · DOI 10.3390/ph13120426 -
Monoclonal Antibodies in Relapsed-Refractory Multiple Myeloma.
Sorgiovanni I, Del Giudice ML, Galimberti S, Buda G. · · 2025 · cited 1× · PMID 40005960 · DOI 10.3390/ph18020145 -
Consensus Guidelines and Recommendations for the anti-CD38-based Therapy in Clinical Practice for Relapsed/Refractory Multiple Myeloma: From the Pan-Pacific Multiple Myeloma Working Group.
Chen W, Cai Z, Chim CS, Chng WJ, et al · · 2025 · PMID 40786241 · DOI 10.46989/001c.141401
Verify or expand the search:
- PubMed search for NCT04287855
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Isatuximab
Trials testing the same drug.
- NCT07045909 — Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma (GEM-AnitoFIRST) · Phase 2 · recruiting
- NCT05862766 — Isatuximab in Lung Transplant Recipients · EARLY_PHASE1 · withdrawn
- NCT05922501 — Isatuximab, Bela Maf, Pom, and Dex in Relapsed/Refractory Multiple Myeloma · Phase 2 · recruiting
- NCT06182774 — Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Mu · Phase 3 · recruiting
- NCT06203912 — Donor Immune Cells (TGFbi NK Cells) and Isatuximab for the Treatment of Relapsed or Refractory Multiple Myeloma · Phase 1 · active not recruiting
Other recruiting trials for Multiple Myeloma in Relapse
Currently open trials in the same condition.
- NCT07096778 — Inobrodib, Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma · Phase 2 · recruiting
- NCT06822972 — HCMT/MM2401: Ph2 Study of Selinexor + Bispecific Antibody for RRMM · Phase 2 · recruiting
- NCT07032129 — Sequential CAR-T Cells Targeting BCMA/GPRC5D in Patients With Relapsed/ Refractory Multiple Myeloma · Phase 1, PHASE2 · recruiting
- NCT07248176 — Universal CAR-T Cell Therapy for MM · NA · recruiting
- NCT06846905 — Cost-utility Analysis of Ambulatory Dose Escalation of Bispecific Antibodies in Multiple Myeloma. · recruiting
Other Poitiers University Hospital trials
Trials by the same sponsor.
- NCT07350291 — Evaluation of the Diagnostic Capabilities of Saliva Samples From Pediatric Patients, Promoting Active Involvement of the · NA · not yet recruiting
- NCT07411651 — Confirmation of the Link Between Endocrine Disruptors Exposure and Breast Cancer and Identification of Biological Respon · NA · not yet recruiting
- NCT07463963 — Relevance of the Urine Bacterial Culture Performed Before TransUrethral Resection of the Bladder for Post-operative Febr · NA · not yet recruiting
- NCT07475442 — Prognostic Factors of Hospitalization for Patients Aged 75 and Over in Emergency Department in France - Monocentric Retr · not yet recruiting
- NCT07412717 — The Efficacy of Combining Music Intervention With Nicotine Replacement Therapy to Reduce Smoking Craving, Among Healthca · NA · 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 NCT04287855 (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 Poitiers University Hospital
- Last refreshed: 10 January 2023
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/NCT04287855.
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