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

Updated: Apr 14, 2022

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

Dara-CyBorD - Lyra Study

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.


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. Identifier: NCT02951819

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

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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


Drug: Daratumumab

Drug: Cyclophosphamide

Drug: Bortezomib

Drug: Dexamethasone


Br J Haematol;2019

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

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

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)


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.

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