NCT02951819: Phase 2 - Evaluate Dara-CyBorD in Previously Untreated and RRMM - LYRA

A Study to Evaluate Dara-CyBorD in Previously Untreated and Relapsed Subjects With Multiple Myeloma

NCT02951819: Phase 2 - Evaluate Dara-CyBorD in Previously Untreated and Relapsed Subjects With Multiple Myeloma - LYRA

Newly Diagnosed Multiple Myeloma

Relapsed Refractory Multiple Myeloma

The purpose of this study is to evaluate complete response plus (+) very good partial response (CR+VGPR) rate following 4 cycles of induction therapy of daratumumab in combination with cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD), in previously untreated subjects, and in relapsed subjects with multiple myeloma, as defined by the International Myeloma Working Group (IMWG) criteria.

Sponsor:

Janssen Scientific Affairs, LLC

Multiple locations

Subjects will receive Daratumumab along with Cyclophosphamide, Bortezomib and Dexamethasone (Dara-CyBorD) as induction on a 28-day cycle length and Daratumab and Dexamethasone on Day 1 of each cycle for 12 cycles as maintenance therapy.

ClinicalTrials.gov Identifier: NCT02951819

Official Title: Daratumumab Plus Cyclophosphamide, Bortezomib and Dexamethasone (Dara-CyBorD) in Previously Untreated and Relapsed Subjects With Multiple Myeloma

Click here to see details on ClinicalTrials.gov

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Daratumumab : National Cancer Institute

Daratumumab : MedlinePlus Drug Information

Bortezomib : National Cancer Institute

Bortezomib : MedlinePlus Drug Information

Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information

Cyclophosphamide : National Cancer Institute

Cyclophosphamide : MedlinePlus Drug Information

Cyclophosphamide IV : MedlinePlus Drug Information

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Drug: Daratumumab

Drug: Cyclophosphamide

Drug: Bortezomib

Drug: Dexamethasone

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Br J Haematol;2019

Daratumumab, bortezomib, cyclophosphamide and dexamethasone in newly diagnosed and relapsed multiple myeloma: LYRA study

https://pubmed.ncbi.nlm.nih.gov/30828799/

Daratumumab (DARA) maintenance therapy following DARA + cyclophosphamide, bortezomib, and dexamethasone (CyBorD) induction therapy in multiple myeloma (MM): End-of-study analysis of LYRA.

Meeting Abstract | 2021 ASCO Annual Meeting

https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.8035

Lyra: A Phase 2 Study of Daratumumab (Dara) Plus Cyclophosphamide, Bortezomib, and Dexamethasone (Cybord) in Newly Diagnosed and Relapsed Patients (Pts) with Multiple Myeloma (MM)

653. MYELOMA: THERAPY, EXCLUDING TRANSPLANTATION: NOVEL ANTIBODY COMBINATIONS IN MYELOMA| NOVEMBER 29, 2018

Conclusion: Dara-CyBorD was active and well tolerated in pts with ND and RMM, including pts with high-risk cytogenetics. ORR, VGPR+, and CR rates improved with cycles 5-8 of induction, indicating that longer therapy with dara results in deeper response. Preliminary PFS and OS data in ND pts in the first year are comparable to dara-VMP. The safety profile was consistent with that previously reported for dara, with no new safety signals observed. Split first daratumumab dosing was feasible, reduced Day 1 infusion time, and resulted in a similar IR rate as previously described for single-dose administration. These findings indicate that dara-CyBorD, using a split-dose first infusion, can be safely administered in the community setting and may be an effective treatment option for pts with MM.

https://doi.org/10.1182/blood-2018-152