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NCT04786028
A Phase 2 Multi-Center, Open Label Study of Isatuximab Added to Standard CyBorD Induction and Lenalidomide Maintenance Treatments in Newly Diagnosed, Transplant Eligible Multiple Myeloma
Phase 2 trial testing Isatuximab in Multiple Myeloma in 72 participants. Participants enrolled and being followed up; not accepting new ones.
1 March 2026
Quick facts
| Lead sponsor | Canadian Myeloma Research Group |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 72 |
| Start date | 8 December 2021 |
| Primary completion | 1 March 2026 |
| Estimated completion | 1 June 2027 |
| Sites | 7 locations across Canada |
Drugs / interventions tested
- Isatuximab (isatuximab) — full drug profile →
Conditions studied
- Multiple Myeloma — all drugs for Multiple Myeloma →
Sponsor
Canadian Myeloma Research Group
Who can join
18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Response rate (VGPR or better) defined by IMWG criteria
Time frame: 100 days
To determine the response rate (VGPR or better) defined by IMWG criteria at 100 days (+/- 7 days) after the autologous stem cell transplant (ASCT).
Sponsor's own description
This is a phase II multi-center, open label, single arm study to evaluate the safety and efficacy of Isatuximab administered intravenously in combination with CyBorD induction treatment and Lenalidomide maintenance treatment in a 28-day long cycle in autologous stem cell transplant-eligible patients.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Immune checkpoint modulators in cancer immunotherapy: recent advances and emerging concepts.
Wang Y, Zhang H, Liu C, Wang Z, et al · · 2022 · cited 179× · PMID 35978433 · DOI 10.1186/s13045-022-01325-0 -
Carfilzomib, lenalidomide, and dexamethasone or lenalidomide alone as maintenance therapy after autologous stem-cell transplantation in patients with multiple myeloma (ATLAS): interim analysis of a randomised, open-label, phase 3 trial.
Dytfeld D, Wróbel T, Jamroziak K, Kubicki T, et al · · 2023 · cited 60× · PMID 36642080 · DOI 10.1016/s1470-2045(22)00738-0 -
Phase 1b Study of Isatuximab in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone in Newly Diagnosed, Transplant-ineligible Multiple Myeloma Patients.
Ocio EM, Bringhen S, Martinez-Lopez J, Martinez-Lopez J, et al · · 2023 · cited 4× · PMID 36751513 · DOI 10.1097/hs9.0000000000000829 -
The Landscape of Currently Enrolling Maintenance Trials in Multiple Myeloma.
Tariq SM, Abdallah AO, Goodman A, Sborov D, et al · · 2023 · cited 3× · PMID 37133718 · DOI 10.1007/s44228-023-00044-8
Verify or expand the search:
- PubMed search for NCT04786028
- 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
Currently open trials in the same condition.
- NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma · Phase 1 · recruiting
- NCT07340853 — CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma · Phase 1 · recruiting
- NCT07454382 — A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma · Phase 2 · recruiting
- 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 Canadian Myeloma Research Group trials
Trials by the same sponsor.
- NCT04258683 — A Study of Pembrolizumab Added to the Standard First-Line Therapy of Cyclophosphamide, Bortezomib, and Dexamethasone (Cy · Phase 2 · withdrawn
- NCT03697629 — A Study of an Accelerated Infusion Rate of Daratumumab in Patients With Relapsed and Refractory Multiple Myeloma · Phase 2 · completed
- NCT03715478 — Multi-Center Study of GSK2857916 in Combination With Pomalidomide and Dex · Phase 1, PHASE2 · active not recruiting
- NCT03215524 — A Study Of Daratumumab, Low-Dose Oral Dexamethasone and Cyclophosphamide With Or Without Pomalidomide · Phase 2 · completed
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 NCT04786028 (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 Canadian Myeloma Research Group
- Last refreshed: 7 January 2025
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/NCT04786028.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing