IPANEMA
Research type
Research Study
Full title
A randomised, open-label, multicentre,phase III trial of in vivo purging with anti-CD38 (Daratumumab) to enhance myeloma autografting
IRAS ID
271709
Contact name
Christopher Parrish
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2019-002147-20
Clinicaltrials.gov Identifier
ERN_19-0760, Ethics self assessment number
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
Despite the introduction of new drugs for the treatment of multiple myeloma (MM), autologous stem cell transplant (ASCT) is still considered the best therapy for a large proportion of all MM patients. Unfortunately, the disease comes back (relapses) in the majority of patients who undergo an ASCT due to residual plasma cells (myeloma cells) either in the blood stem cells collected during the separation of cells in preparation for the transplant, or remaining in the bone marrow despite all treatments. Patients will commonly receive stem cells that are contaminated with myeloma cells which can reduce the effect of chemotherapy in destroying the myeloma cells pre-transplant. A few studies have investigated strategies to obtain purified stem cell collections in the past, but due to limitations and the poor quality pre-transplant response these approaches have been ineffective. The goal of this trial is to see if the addition of the drug daratumumab to the stem cell collection process and the stem cell transplant can reduce the level of myeloma cells present in the bone marrow 100 days after the transplant and lead to improved long-term outcomes for MM patients.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
20/SC/0341
Date of REC Opinion
11 Nov 2020
REC opinion
Further Information Favourable Opinion