Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone Induction Therapy for Transplant-Eligible Newly Diagnosed Multiple Myeloma: Final Part 1 Analysis of the GMMG-HD7 Trial
Research output: Contribution to journal › Research article › Contributed › peer-review
Contributors
- Department of Internal Medicine I
- University Hospital Heidelberg
- University Hospital Duesseldorf
- University Hospital Tübingen
- University Hospital Essen
- LWL University Hospital Bochum
- University Hospital Frankfurt
- Klinikum Chemnitz gGmbH
- University Hospital Gießen and Marburg
- University Hospital Hamburg Eppendorf
- Hospital of the Brothers of Mercy Regensburg
- Uniklinik Köln
- Charité – Universitätsmedizin Berlin
- University of Bonn Medical Center
- RWTH Aachen University
- Marien Hospital Düsseldorf
- KRH Hospital Siloah
- University Hospital Münster
- Agaplesion Bethanien Hospital
- University Medical Center Mainz
- Diakoneo Clinic Schwäbisch-Hall
- Medical Center Bethel
- Practice for hematology and oncology
- Klinikum Ludwigshafen
- Asklepios Cancer Center Hamburg
Abstract
Previously, addition of isatuximab (Isa) to standard-of-care lenalidomide-bortezomib-dexamethasone (RVd) in transplant-eligible patients with newly diagnosed multiple myeloma in the GMMG-HD7 trial (ClinicalTrials.gov identifier: NCT03617731) resulted in a significant increase of minimal residual disease negativity (MRD-) rates after induction therapy. A total of 662 patients were randomly assigned to receive induction therapy with Isa-RVd (n = 331) or RVd (n = 329), followed by single or tandem autologous stem-cell transplant and second random assignment to maintenance with lenalidomide alone or Isa-lenalidomide. We report updated results for part 1 from first random assignment to post-transplant. As of January 31, 2024, MRD- rates continued to deepen after transplant (66% Isa-RVd v 48% RVd). Isa-RVd induction therapy significantly prolonged progression-free survival (PFS) compared with RVd regardless of maintenance therapy (hazard ratio, 0.70 [95% CI, 0.52 to 0.95]; P = .0184). Weighted risk set estimator analysis accounting for second random assignment followed by maintenance with only lenalidomide confirmed a statistically significant benefit for Isa-RVd followed by lenalidomide maintenance versus RVd followed by lenalidomide maintenance (stratified weighted log-rank test P = .016). In conclusion, after 18-week induction therapy followed by transplant without consolidation therapy, adding Isa to RVd resulted in a significant PFS benefit, regardless of maintenance strategy.
Details
| Original language | English |
|---|---|
| Article number | JCO2402266 |
| Pages (from-to) | 1279-1288 |
| Number of pages | 10 |
| Journal | Journal of Clinical Oncology |
| Volume | 43 |
| Issue number | 11 |
| Early online date | 9 Dec 2024 |
| Publication status | Published - Apr 2025 |
| Peer-reviewed | Yes |
External IDs
| unpaywall | 10.1200/jco-24-02266 |
|---|---|
| Scopus | 105002338667 |
Keywords
Keywords
- Dexamethasone/administration & dosage, Bortezomib/administration & dosage, Humans, Middle Aged, Hematopoietic Stem Cell Transplantation, Lenalidomide/administration & dosage, Male, Induction Chemotherapy, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Neoplasm, Residual, Antibodies, Monoclonal, Humanized/administration & dosage, Progression-Free Survival, Female, Adult, Aged, Multiple Myeloma/drug therapy