Last reviewed · How we verify
NCT05344833: HEME-18
Post-Autologous Transplant Maintenance With Isatuximab and Lenalidomide in Minimal Residual Disease Positive Multiple Myeloma
Phase 2 trial testing Isatuximab in Multiple Myeloma in 50 participants. Currently enrolling.
1 December 2030
Quick facts
| Lead sponsor | University of Illinois at Chicago |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 5 January 2023 |
| Primary completion | 1 December 2030 |
| Estimated completion | 1 December 2030 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Isatuximab (isatuximab) — full drug profile →
- Lenalidomide — full drug profile →
Conditions studied
- Multiple Myeloma — all drugs for Multiple Myeloma →
Sponsor
University of Illinois at Chicago
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.
-
Number of participants that have MRD-negative CR rate, defined as 10-6
Time frame: 1 year
Evaluate the number of participants that have MRD-negative at 1 year that were MRD-positive multiple myeloma (MM) treated with isatuximab and lenalidomide based maintenance after ASCT
Sponsor's own description
This is a phase II study where patients will undergo isatuximab and lenalidomide maintenance if they are MRD-positive after Autologous Stem Cell Transplant (ASCT)
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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 NCT05344833
- 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- NCT05862766 — Isatuximab in Lung Transplant Recipients · EARLY_PHASE1 · withdrawn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 University of Illinois at Chicago trials
Trials by the same sponsor.
- NCT07498322 — Chicago Data-driven Opioid Use Disorder Screening, Engagement, Treatment and Planning System · NA · not yet recruiting
- NCT07387705 — On Track for Wellness (OTW) Stepped Wedge Cluster Randomized Trial · Phase 1 · not yet recruiting
- NCT07504120 — The Effect of Remotely Delivered Pilates on Physical , and Psychological Outcomes in Individuals With Multiple Sclerosis · NA · not yet recruiting
- NCT07160582 — Cognitive-Motor Training for AD/ADRD Prevention · NA · not yet recruiting
- NCT07498348 — Apple Watch Evaluation of Endodontics Occupational Stress · 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 NCT05344833 (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 University of Illinois at Chicago
- Last refreshed: 19 February 2026
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/NCT05344833.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing