Cyclophosphamide-Bortezomib-Dexamethasone (CyBorD) With Daratumumab (DARA)

Sponsor
National University of Ireland, Galway, Ireland
Study ID
NCT02955810
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
  • Cyclophosphamide — DRUG
  • Bortezomib — DRUG
  • Dexamethasone — DRUG

Study Details

This study is a Phase Ib open label, single arm, adaptive multicentre trial. Patients with newly diagnosed Multiple Myeloma (MM) will be treated with Cyclophosphamide-Bortezomib-Dexamethasone (CyBorD) in combination with Daratumumab (DARA). The safety profile of daratumumab to date, which does not appear to overlap with those known for approved agents, combined with its distinct MoA, suggest that the therapeutic profile of daratumumab combined with various backbone regimens may improve the treatment effect of these regimens. Additionally, daratumumab as a single agent may prolong the progression free interval for these patients. Based on the potential for cyclophosphamide to enhance ADCP, there is a strong rationale to combine DARA with a cyclophosphamide, bortezomib containing regimen. This will be the first clinical trial to explore the feasibility of combining daratumumab with a cyclophosphamide containing backbone induction regimen and if successful will provide the rationale for larger studies exploring the efficacy of this combination in greater detail.

Key Dates

Start date
Nov 30, 2016
Status verified
Mar 2018
Primary completion
Sep 30, 2018
Completion
Nov 30, 2020

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CyBorD-DARA

Primary Outcome Measure

MTD [ Time Frame: 15 months ]

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