Trial intelligence / Profile preview

GEN3014 in Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies

NCT04824794Phase 2

Key facts

Status: Terminated
Start: Mar 2021
Primary completion: Jun 2025
Countries: 20
Sponsor: Genmab
Modality: Monoclonal Antibodies

Drugs: gen3014
Conditions: multiple myeloma (MM)acute myeloid leukemia (AML)diffuse large B-cell lymphoma (DLBCL)

Overview

Phase 2, randomised, open-label trial of gen3014 in multiple myeloma (MM), acute myeloid leukemia (AML) and diffuse large B-cell lymphoma (DLBCL) (2 arms), sponsored by Genmab. Primary endpoints: Dose Limiting Toxicities at 28 days, Adverse Events and Serious Adverse Events and 1 more. Started Mar 2021; status: terminated.

Design

2 arms

Study design: RandomizedOpen-label

GEN3014
Participants receive GEN3014 via intravenous infusion.
Daratumumab
Participants receive daratumumab via subcutaneous injection (Expansion Part B only).

Who it enrols

Patients with relapsed or refractory multiple myeloma, acute myeloid leukemia, or diffuse large B-cell lymphoma who have exhausted standard therapies. Requires adequate organ function and ECOG PS 0-2 (0-1 for DLBCL). Excludes patients with prior CD38-directed therapy (for naive cohort), active CNS involvement, or significant cardiac disease.

Endpoints

Primary

Dose Limiting Toxicities28 days
Adverse Events and Serious Adverse EventsUp to approximately 4 years 3 months
Objective Response RateUp to approximately 4 years 3 months

Secondary

Maximum Plasma ConcentrationCycle 2 Day 1
Pre-dose (Trough) ConcentrationsCycle 8 Day 1
Area Under the Concentration Time Curve From Zero to Last Quantifiable SampleCycle 2 Day 1
Area Under the Concentration Time Curve From Zero to 168 HoursCycle 2 Day 1
Anti-Drug AntibodiesUp to approx. 34.5 months
Clinical Benefit RateUp to approximately 4 years 3 months
Duration of ResponseUp to approximately 4 years 3 months
Time-to-responseUp to approximately 4 years 3 months

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