IPANEMA

IPANEMA: A randomised, open-label, multicentre, Phase III trial of in vivo purging with anti-CD38 (Daratumumab) to enhance myeloma autografting

Study design/summary:  This is a randomised prospective, open-label, multicentre, Phase III trial that will assign newly diagnosed transplant-eligible patients, who have already received induction chemotherapy with proteasome inhibitor-based combinations and responded to it (≥ partial response), to undergo stem cell collection and autologous stem cell transplant (ASCT) as per standard of care (control group) or to receive 2 doses of Daratumumab at the time of collection and 2 doses at the time of ASCT as in vivo purging strategy (experimental group).

Objectives:

  • The primary objective is to compare the percentage of patients with MRD negative bone marrow aspirate on day 100 after an autologous stem cell transplant in patients who have received standard of care stem cell collection and ASCT (control arm) to those receiving the in vivo purging strategy with the addition of Daratumumab at time of cell collection and at time of the ASCT (experimental arm).
  • The secondary objectives are to compare safety and toxicity of addition of Daratumumab to Peripheral Blood Stem Cell (PBSC) harvest and ASCT;  proportion of patients in each arm achieving a log reduction in disease burden (by multiparameter flow cytometry) comparing pre ASCT bone marrow (BM) aspirate and day 100 post-ASCT BM aspirate; proportion of patients completing treatment as per protocol; time to engraftment; PBSC harvest yield; rate of graft failure or delay engraftment; Progression Free Survival (PFS); Time to Next Treatment (TnT) and overall survival (OS).

Centres:  22 IMPACT centres

Target Number of patients:  A minimum of 338 patients will be randomised 1:1 between the control and experimental arms across IMPACT centres.

Patient population:  This trial will recruit patients newly diagnosed with Multiple Myeloma (MM) as defined by the WHO classification  who have achieved at least a partial response (PR) following induction therapy and are suitable to undergo an autologous stem cell transplant.

Sponsorship/Funding:  University of Birmingham, funded by the IMPACT network

Trial Status:  In set-up

Start Date:  TBC

Duration2 years.  Patients will be recruited over 24 months across the IMPACT centres. Patients will be followed up clinically in the transplant centre until D100 post-ASCT, and then remotely by ‘virtual follow-up’ for 10 years.

Trial Contacts:  IPANEMA@trials.bham.ac.uk

If you are a patient and interested in taking part in a clinical trial, please speak with your consultant who will be able to offer you further information and discuss whether it is suitable for you.  A referral from your medical team would be required in order to consider you for treatment on a clinical trial.