Daratumumab in Indian patients with relapsed and refractory multiple myeloma: a prospective, multicenter, phase IV study.
Lalit KumarSameer MelinkeriPrasanth GanesanJeevan KumarGhanashyam BiswasNalini KilaraHarish PathalingappaSvss PrasadMinish JainSourav Kumar MishraSaurabh PrasadPavan Kumar BoyellaRanjit Kumar SahooShailesh BondardeSandip ShahMilind RegeUttiya DebTanuja KordeJitendra DixitPublished in: Future oncology (London, England) (2023)
Aim: To assess the safety and effectiveness of daratumumab monotherapy in Indian patients with relapsed/refractory multiple myeloma. Methods: In this prospective, multicenter, phase IV study, patients (aged ≥18 years) received intravenous daratumumab (16 mg/kg) in six cycles. Safety was the primary end point. Results: Of the 139 patients included, 121 (87.1%) experienced ≥1 treatment-emergent adverse events (TEAEs; 53 [38.1%] drug-related), 32 (23%) had ≥1 serious TEAEs (five [3.6%] drug-related) and 16 (11.5%) deaths were reported (one death [0.7%] was drug-related). Overall response rate was 26.3%; 62.7% of patients had stable disease. Median time to first response and median progression-free survival were 5.2 and 5.9 months, respectively. Functional status and well-being were improved. Conclusion: Daratumumab showed an acceptable and expected safety profile with consistent efficacy, providing a novel therapeutic option for relapsed/refractory multiple myeloma management in India.
Keyphrases
- multiple myeloma
- end stage renal disease
- newly diagnosed
- ejection fraction
- chronic kidney disease
- acute myeloid leukemia
- acute lymphoblastic leukemia
- randomized controlled trial
- diffuse large b cell lymphoma
- free survival
- emergency department
- patient reported outcomes
- cross sectional
- drug induced
- open label
- patient reported
- adverse drug