Personalising Treatment for Myeloma Patients Based on Initial Response to NHS Treatment and Their Overall Fitness Level

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Leeds

About this trial

iFIT is a trial for newly diagnosed transplant-ineligible patients with the bone marrow cancer myeloma. These patients are generally older and have a lower level of fitness than others. Patients can take part if their doctor would otherwise recommend the standard NHS treatment daratumumab, lenalidomide and dexamethasone (DRd). After six months of DRd, the subsequent treatment a patient receives in iFIT is based on two factors: the patient's fitness level and treatment response. The trial compares different treatment strategies to determine whether outcomes can be improved for specific patient groups.

Eligibility criteria

Qualifiers

Newly diagnosed as having symptomatic MM, plasma cell leukaemia or non-secretory MM according to IMWG diagnostic criteria 2014.

Considered not suitable to receive autologous stem cell transplant as part of their first line therapy by the treating clinician,

Planned for treatment with Daratumumab, Lenalidomide and dexamethasone (DRd) as first line therapy as standard of care,

Aged 18 years or greater,

Disqualifiers

Smouldering myeloma (SMM), primary amyloidosis, solitary plasmacytoma of bone or extramedullary plasmacytoma (without additional evidence of myeloma),

Pregnant, breastfeeding, plans to become pregnant, or plans to father a child whilst enrolled in the study or within 3 months after the last dose,

Previous treatment for myeloma, except as specified in the protocol,

Active systemic viral, fungal or bacterial infection requiring systemic therapy. Criteria for specific chronic infections clarified in the protocol, or

Trial design

Treatments tested in this trial

  • Daratumumab
  • Lenalidomide
  • Dexamethasone
  • Teclistamab
  • Talquetamab

Treatment groups

1,226 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Sponsors and collaborators

University of Leeds

Lead sponsor

Cancer Research UK

Collaborator

Blood Cancer UK

Collaborator

Johnson & Johnson

Collaborator