Last reviewed · How we verify
NCT04912427
Isatuximab, Velcade, and Dexamethasone in Patients With Multiple Myeloma and Severe KIDNEY Disease
Phase 1 trial testing Isatuximab in Multiple Myeloma in 1 participant. Terminated before completion.
6 December 2022
Quick facts
| Lead sponsor | Washington University School of Medicine |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 1 April 2022 |
| Primary completion | 6 December 2022 |
| Estimated completion | 26 January 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Isatuximab (isatuximab) — full drug profile →
- Bortezomib (bortezomib) — full drug profile →
- Dexamethasone (dexamethasone) — full drug profile →
Conditions studied
- Multiple Myeloma — all drugs for Multiple Myeloma →
Sponsor
Washington University School of Medicine
Who can join
18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a phase Ib study to assess the safety, tolerability, preliminary efficacy, and renal response of isatuximab, bortezomib, and dexamethasone in newly diagnosed multiple myeloma patients with severe renal impairment or dialysis-dependent end-stage renal disease. Such patients have limited therapeutic options due to renal clearance or nephrotoxicity of many myeloma therapies and are often excluded from clinical trials. Isatuximab in other regimens has shown efficacy and tolerability in patients with moderate renal impairment, although data are lacking for regimens containing CD38-targeting immunotherapies in severe renal impairment/ESRD.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Landscape of adenosine pathway and immune checkpoint dual blockade in NSCLC: progress in basic research and clinical application.
Wang R, Liu Z, Wang T, Zhang J, et al · · 2024 · cited 7× · PMID 38348050 · DOI 10.3389/fimmu.2024.1320244
Verify or expand the search:
- PubMed search for NCT04912427
- 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 Washington University School of Medicine trials
Trials by the same sponsor.
- NCT05521997 — Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer · Phase 2 · not yet recruiting
- NCT07101666 — Total Neoadjuvant Therapy With Short Course Radiation Therapy in Gastric Cancer · Phase 2 · not yet recruiting
- NCT07200089 — Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel) · Phase 1 · not yet recruiting
- NCT07313592 — Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients · not yet recruiting
- NCT07419464 — 5-Fluorouracil Response and Optimization STudy (The FROST Trial) · Phase 2 · 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 NCT04912427 (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 Washington University School of Medicine
- Last refreshed: 9 February 2024
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/NCT04912427.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing