MedTrace Logo

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

NCT07649525 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1226

Last updated 2026-07-15

No results posted yet for this study

Summary

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.

Conditions

  • Multiple Myeloma (MM)
  • Plasma Cell Leukemia (PCL)

Interventions

DRUG

Teclistamab

Participants will receive teclistamab by subcutaneous injection. Each cycle is 28 days.

DRUG

Talquetamab

Participants will receive talquetamab by subcutaneous injection. Each cycle is 28 days.

DRUG

Lenalidomide

Taken orally as capsules. Each cycle is 28 days. Dose can be adjusted for frailty and renal function.

DRUG

Dexamethasone

Taken as oral tablets, oral solution, or given by IV. Each cycle is 28 days. Dose can be adjusted for frailty and renal function.

DRUG

Daratumumab

Participants will receive daratumumab by subcutaneous injection. Each cycle is 28 days.

Sponsors & Collaborators

Principal Investigators

  • Gordon Cook · Leeds Institute of Clinical Trials Research

  • Charlotte Pawlyn · Institute of Cancer Research, United Kingdom

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2033-06-30
Completion
2037-06-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07649525 on ClinicalTrials.gov