A Phase 3b, Multicenter, Open-label, Daratumumab Long-term Extension Study
Research type
Research Study
Full title
A Phase 3b, Multicenter, Open-label, Daratumumab Long-term Extension Study
IRAS ID
1008068
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
0000-000000-00
Clinicaltrials.gov Identifier
Research summary
Janssen Cilag International NV, the sponsor, is running a Phase 3b, multicentre, open-label Daratumumab long-term extension study, designed to provide ongoing access to study treatments for participants with multiple myeloma or smoldering multiple myeloma who are benefiting from treatment in certain Janssen R&D studies that use Daratumumab as part of the study treatment regimen. This study will also collect certain long-term safety data from study participants.
Daratumumab activity has been investigated in multiple studies of intravenous (IV) or subcutaneous (SC) daratumumab monotherapy and combination therapy. Daratumumab IV and daratumumab SC have both received marketing authorisations; daratumumab IV is approved in over 90 countries, whilst daratumumab SC is approved in over 50 countries for treatment of multiple myeloma. Daratumumab recognises and binds to the surface of cancerous tumour cells. Currently the sponsor has limited information regarding the effect of daratumumab on Hepatitis B Virus (HBV) reactivation. This study will therefore be utilised to continue to evaluate if long-term treatment with daratumumab may cause HBV reactivation, whilst also providing ongoing access to participants who are being shown to benefit from the study treatment.
It is estimated approximately 500 participants may roll over from various Janssen parent studies. Participants will continue their current study treatment dosing regimen established in the parent study. During screening, participants will continue to receive study treatment in the parent study. During the treatment phase, participants will continue this same study treatment; the cycle count will restart as Cycle 1, Day 1. Each cycle will be the same as the parent study. Participants receiving daratumumab IV will be given the opportunity on Day 1 of each cycle to switch to daratumumab SC.
Janssen Cilag International NV will organise and fund this study.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0359
Date of REC Opinion
7 Nov 2023
REC opinion
Further Information Unfavourable Opinion