Daratumumab, Bortezomib, and Dexamethasone for Treatment of Patients with Relapsed or Refractory Multiple Myeloma and Severe Renal Impairment: Results from the Phase 2 GMMG-DANTE Trial
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
3. Results
3.1. Patients and Treatment
3.2. Efficacy
3.3. Safety
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Appendix A
References
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Characteristic | ||
---|---|---|
Age | Median (range) (years) | 70 (55–89) |
≥75 years–n (%) | 7 (33.3) | |
Sex | Male–n (%) | 12 (57.1) |
Female–n (%) | 9 (42.9) | |
Median time since initial therapy–years (range) | 4.01 (0.23–11.41) | |
ECOG performance status score | 0–n (%) | 7 (33.3) |
1–n (%) | 10 (47.6) | |
2–n (%) | 4 (19.0) | |
3–n (%) | 0 | |
Body mass index–median (range) (kg/m2) | 25.9 (17.3–35.9) | |
High risk cytogenetics a | ≥1 aberration | 5 (50.0) |
≥2 aberrations | 3 (30.0) | |
Gain1q21 | 5 (50.0) | |
t (4;14) | 2 (20.0) | |
Del (17p13) | 2 (20.0) | |
Type of myeloma | Light chain–n (%) | 11 (52.4) |
IgG–n (%) | 7 (33.3) | |
IgA–n (%) | 2 (9.5) | |
Missing | 1 (4.8) | |
GFR–median (range; IQR) (ml/min/1.73 m2) b | 20 (3.9–30; IQR 9.4–27.3) | |
Undergoing hemodialysis–n (%) | 8 (38.1) | |
Prior treatment lines–median (range) | 2 (1–10) | |
Prior bortezomib exposure–n (%) | 20 (95.2) | |
Prior lenalidomide exposure–n (%) | 9 (42.9) | |
Prior stem cell transplantation–n (%) | 6 (28.6) | |
Comorbidities n (%) c | Arterial hypertension | 9 (42.9) |
Diabetes mellitus | 4 (19.0) | |
Anemia | 4 (19.0) | |
Hyperuricemia/gout | 3 (14.3) | |
Bone pain | 3 (14.3) |
Adverse Event | All Grades–n (%) | Grade ≥ 3–n (%) |
---|---|---|
Hematologic | ||
Anemia | 8 (38.1) | 4 (19.0) |
Leukopenia | 3 (14.3) | 1 (4.8) |
Neutropenia | 2 (9.5) | 1 (4.8) |
Lymphopenia | 8 (38.1) | 5 (23.8) |
Thrombocytopenia | 11 (52.4) | 4 (19.0) |
Infectious | ||
Upper respiratory tract infection/bronchial infection/common cold | 9 (42.9) | 0 |
Pneumonia | 3 (14.3) | 3 (14.3) |
Infection, Not specified | 4 (19.0) | 0 |
Sepsis | 2 (9.5) | 2 (9.5) |
Neurologic | ||
Peripheral polyneuropathy | 11 (52.4) | 1 (4.8) |
Concentration disorder | 2 (9.5) | 0 |
Cardiovascular | ||
Arterial hypertension | 4 (19.0) | 1 (4.8) |
Edema | 8 (38.1) | 0 |
Dyspnea | 5 (23.8) | 0 |
Hypotension | 2 (9.5) | 0 |
General condition | ||
Pain/back pain/bone pain | 10 (47.6) | 2 (9.5) |
Fatigue | 8 (38.1) | 1 (4.8) |
Insomnia | 3 (14.3) | 0 |
Reduced general condition | 3 (14.3) | 0 |
Dizziness | 3 (14.3) | 0 |
Weakness | 2 (9.5) | 0 |
Cough | 2 (9.5) | 0 |
Gastrointestinal | ||
Nausea | 7 (33.3) | 0 |
Diarrhea | 2 (9.5) | 0 |
Dysgeusia | 2 (9.5) | 0 |
Meteorism | 2 (9.5) | 0 |
Vomiting | 2 (9.5) | 0 |
Other | ||
Infusion reaction | 4 (19.0) | 0 |
Secondary primary malignancy | 2 (9.5) | 1 (4.8) |
Renal function impairment | 2 (9.5) | 2 (9.5) |
Severe Adverse Event | All Grades–n (%) | Grade ≥ 3–n (%) |
---|---|---|
Infections (in total) | 5 (23.8) | 4 (19.0) |
Pneumonia | 2 (9.5) | 2 (9.5) |
Sepsis | 2 (9.5) | 2 (9.5) |
Influenza | 1 (4.8) | 0 |
Back Pain | 1 (4.8) | 1 (4.8) |
Diarrhea | 1 (4.8) | 0 |
Disc prolapse | 1 (4.8) | 1 (4.8) |
Dyspnea | 1 (4.8) | 0 |
Femoral fracture | 1 (4.8) | 1 (4.8) |
Gastritis | 1 (4.8) | 1 (4.8) |
Gastrointestinal bleeding | 1 (4.8) | 1 (4.8) |
Hematuria | 1 (4.8) | 00 |
Hypercalcemia | 1 (4.8) | 1 (4.8) |
Lewy body dementia | 1 (4.8) | 1 (4.8) |
Malignant arrhythmia | 1 (4.8) | 1 (4.8) |
Posterior reversible encephalopathy syndrome | 1 (4.8) | 1 (4.8) |
Progressive disease | 1 (4.8) | 0 |
Renal function impairment | 1 (4.8) | 0 |
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Leypoldt, L.B.; Gavriatopoulou, M.; Besemer, B.; Salwender, H.; Raab, M.S.; Nogai, A.; Khandanpour, C.; Runde, V.; Jauch, A.; Zago, M.; et al. Daratumumab, Bortezomib, and Dexamethasone for Treatment of Patients with Relapsed or Refractory Multiple Myeloma and Severe Renal Impairment: Results from the Phase 2 GMMG-DANTE Trial. Cancers 2023, 15, 4667. https://doi.org/10.3390/cancers15184667
Leypoldt LB, Gavriatopoulou M, Besemer B, Salwender H, Raab MS, Nogai A, Khandanpour C, Runde V, Jauch A, Zago M, et al. Daratumumab, Bortezomib, and Dexamethasone for Treatment of Patients with Relapsed or Refractory Multiple Myeloma and Severe Renal Impairment: Results from the Phase 2 GMMG-DANTE Trial. Cancers. 2023; 15(18):4667. https://doi.org/10.3390/cancers15184667
Chicago/Turabian StyleLeypoldt, Lisa B., Maria Gavriatopoulou, Britta Besemer, Hans Salwender, Marc S. Raab, Axel Nogai, Cyrus Khandanpour, Volker Runde, Anna Jauch, Manola Zago, and et al. 2023. "Daratumumab, Bortezomib, and Dexamethasone for Treatment of Patients with Relapsed or Refractory Multiple Myeloma and Severe Renal Impairment: Results from the Phase 2 GMMG-DANTE Trial" Cancers 15, no. 18: 4667. https://doi.org/10.3390/cancers15184667