Clinical trial · no report yet · Phase 3
GMMG HD7
Trial on the Effect of Isatuximab to Lenalidomide/Bortezomib/Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma (GMMG HD7)
- NCT03617731 ↗
- Active, not recruiting
- University of Heidelberg Medical Center
- Focused
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Preliminary discovery
Commentary in our index that names this trial so far
Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.
| Channel | Found | |
|---|---|---|
| X threads | 3 |
The trial
ClinicalTrials.gov- Official title
- A Randomized Phase III Trial Assessing the Benefit of the Addition of Isatuximab to Lenalidomide / Bortezomib / Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma
- Phase
- Phase 3
- Status
- Active, not recruiting
- Conditions
- Multiple Myeloma
- Interventions
- Lenalidomide; Bortezomib; Dexamethasone; Isatuximab
- Arms
- IA · Active comparator
- IB · Experimental
- IIA · Active comparator
- IIB · Experimental
- Enrollment
- 662
- Primary outcomes
- MRD negativity after induction Treatment (comparison of arms IA and IB)
- Progression Free Survival (PFS) after second randomization (arms IIA and IIB)
- Sponsor
- University of Heidelberg Medical Center
- Start
- Oct 18, 2018
- Primary completion
- Jun 2028 (estimated)
- Results posted
- No
- Registry record
- NCT03617731 · updated Feb 3, 2026
Publications
linked from the registry- Jin JX, Ginde VR, Huhn S, Reichert P, Bertsch U, Fenk R, Besemer B, Boquoi A, Schroers R, von Metzler I, Hanel M, Mann C, Leypoldt LB, Heilmeier B, Scheid C, Peters-Regehr T, Blau IW, Muller-Tidow C, Luntz S, Holderried TAW, Trautmann-Grill K, Gezer D, Klaiber-Hakimi M, Muller M, Shumilov E, Knauf W, Michel CS, Geer T, Riesenberg H, Lutz C, Raab MS, Weinhold N, Hoffmann M, Benner A, Findeisen P, Weisel KC, Salwender HJ, Mai EK, Goldschmidt H; German-Speaking Myeloma Multicenter Group (GMMG) HD7 Investigators. Peripheral Measurable Residual Disease Activity Assessment by MALDI-TOF Mass Spectrometry in Patients With Newly Diagnosed Multiple Myeloma in the Phase III GMMG-HD7 Trial. J Clin Oncol. 2026 Aug;44(22):2079-2086. doi: 10.1200/JCO-25-02957. Epub 2026 May 21. PubMed 42166704
- Mai EK, Bertsch U, Pozek E, Fenk R, Besemer B, Hanoun C, Schroers R, von Metzler I, Hanel M, Mann C, Leypoldt LB, Heilmeier B, Huhn S, Vogel SK, Hundemer M, Scheid C, Blau IW, Luntz S, Weinhold N, Tichy D, Holderried TAW, Trautmann-Grill K, Gezer D, Klaiber-Hakimi M, Muller M, Shumilov E, Knauf W, Michel CS, Geer T, Riesenberg H, Lutz C, Raab MS, Benner A, Hoffmann M, Weisel KC, Salwender HJ, Goldschmidt H; German-Speaking Myeloma Multicenter Group (GMMG) HD7 Investigators; German-speaking Myeloma Multicenter Group (GMMG) HD7. Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone Induction Therapy for Transplant-Eligible Newly Diagnosed Multiple Myeloma: Final Part 1 Analysis of the GMMG-HD7 Trial. J Clin Oncol. 2025 Apr 10;43(11):1279-1288. doi: 10.1200/JCO-24-02266. Epub 2024 Dec 9. PubMed 39652594
- Mai EK, Hielscher T, Bertsch U, Salwender HJ, Zweegman S, Raab MS, Munder M, Pantani L, Mancuso K, Brossart P, Beksac M, Blau IW, Durig J, Besemer B, Fenk R, Reimer P, van der Holt B, Hanel M, von Metzler I, Graeven U, Muller-Tidow C, Boccadoro M, Scheid C, Dimopoulos MA, Hillengass J, Weisel KC, Cavo M, Sonneveld P, Goldschmidt H. Predictors of early morbidity and mortality in newly diagnosed multiple myeloma: data from five randomized, controlled, phase III trials in 3700 patients. Leukemia. 2024 Mar;38(3):640-647. doi: 10.1038/s41375-023-02105-6. Epub 2023 Dec 7. PubMed 38062124
- Kauer J, Freundt EP, Schmitt A, Weinhold N, Mai EK, Muller-Tidow C, Goldschmidt H, Raab MS, Kriegsmann K, Sauer S. Stem cell collection after lenalidomide, bortezomib and dexamethasone plus elotuzumab or isatuximab in newly diagnosed multiple myeloma patients: a single centre experience from the GMMG-HD6 and -HD7 trials. BMC Cancer. 2023 Nov 21;23(1):1132. doi: 10.1186/s12885-023-11507-9. PubMed 37990162
- Goldschmidt H, Mai EK, Bertsch U, Fenk R, Nievergall E, Tichy D, Besemer B, Durig J, Schroers R, von Metzler I, Hanel M, Mann C, Asemissen AM, Heilmeier B, Weinhold N, Huhn S, Kriegsmann K, Luntz SP, Holderried TAW, Trautmann-Grill K, Gezer D, Klaiber-Hakimi M, Muller M, Khandanpour C, Knauf W, Scheid C, Munder M, Geer T, Riesenberg H, Thomalla J, Hoffmann M, Raab MS, Salwender HJ, Weisel KC; German-Speaking Myeloma Multicenter Group (GMMG) HD7 investigators. Addition of isatuximab to lenalidomide, bortezomib, and dexamethasone as induction therapy for newly diagnosed, transplantation-eligible patients with multiple myeloma (GMMG-HD7): part 1 of an open-label, multicentre, randomised, active-controlled, phase 3 trial. Lancet Haematol. 2022 Nov;9(11):e810-e821. doi: 10.1016/S2352-3026(22)00263-0. PubMed 36328040