Isatuximab and Iberdomide as Immunotherapy for High Risk in Smouldering Myeloma

Sponsor
University College, London
Study ID
NCT06762769
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Smouldering Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Isatuximab — DRUG
    Subcutaneous isatuximab will be delivered using an unlicensed medical device (On Body Delivery System)
  • Iberdomide — DRUG
    Oral iberdomide
  • Dexamethasone — DRUG
    Oral dexamethasone

Study Details

The study will test a new combination of 3 drugs: Isatuximab (Isa), Iberdomide (Iber) and Dexamethasone (Dex), in patients who have intermediate or high risk smouldering myeloma. Smouldering myeloma is an early form of myeloma which may progress to active multiple myeloma, but at a slow rate. Patients with smouldering myeloma do not usually receive any treatment but will have regular check-ups and observation. Some patients have a diagnosis of smouldering myeloma which has a higher risk of progressing to active myeloma. The study will test if the combination of drugs is effective at preventing or delaying the disease progressing into active multiple myeloma. The study will also test if the combination is tolerated and accepted by patients.

Key Dates

Start date
Jun 2, 2025
Status verified
Dec 2024
Primary completion
Nov 30, 2032
Completion
Nov 30, 2032

Study Design

Enrollment
63 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Study treatment
    All patients will receive 2 years of treatment, over 26 cycles. A cycle is 28 days. The treatment is split into 3 stages. Induction therapy: Cycle 1-4 * Isatuximab is given once a week in cycle 1. Then twice a week in cycle 2-4. It is given subcutaneously using a medical device called an On Body Delivery System * Iberdomide is given on days 1-21. It is given as an oral capsule. * Dexamethasone is given once a week. It is given as an oral tablet. Consolidation therapy: Cycle 5-13 * Isatuximab is given twice a week. * Iberdomide is given on days 1-21 Maintenance therapy: Cycle 14-26 * Isatuximab is given once a month * Iberdomide is given on days 1-21

Primary Outcome Measure

Treatment deliverability, measured by treatment discontinuation before completion of 26 cycles [ Time Frame: From the date of registration until the date of treatment completion/discontinuation (approximately 2 years or earlier if patients discontinue treatment early) ]

Central Contacts