Randomised Trial To Evaluate 3 Daratumumab Dose Schedules in SMM
Research type
Research Study
Full title
A Randomized Phase 2 Trial to Evaluate Three Daratumumab Dose Schedules in Smoldering Multiple Myeloma
IRAS ID
172463
Contact name
Martin Kaiser
Contact email
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2014-005139-14
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 4 months, 1 days
Research summary
This is a randomised, open-label, 3-arm, multi-centre trial in participants at least 18 years old with intermediate or high-risk smouldering multiple myeloma (SMM). SMM is a pre-malignant condition in which patients have abnormal plasma cells in the bone marrow but no other clinical symptoms. SMM progresses to symptomatic malignant myeloma (MM) at a rate of about 10% per year. Currently there are no approved treatment options for patients with SMM outside clinical trials. Clinical management involves close monitoring until development of symptomatic disease .
In this trial 120 participants will be enrolled into one of three treatment groups involving 8 week treatment cycles of dosing with daratumumab 16mg/kg. a monoclonal antibody.
In Arm A, daratumumab will be administered weekly in Cycle 1, every other week in Cycle 2 and Cycle 3, every 4 weeks in Cycle 4 to Cycle 7, and from Cycle 8 to Cycle 20 on Day 1 of each cycle. In Arm B, daratumumab will be administered weekly in Cycle 1 and then on Day 1 of each cycle from Cycle 2 to Cycle 20. For subjects randomized to Arm C, the Treatment Phase consists of Cycle 1 only, when daratumumab will be administered weekly.
After treatment participants will be followed up until death unless they are lost to follow-up or withdraw consent. The entire trial will end 4 years after the first dose of the final patient.
Assessments include measurement of blood pressure and pulse, ECG, and blood and urine tests for relevant chemical markers.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
15/WM/0102
Date of REC Opinion
11 May 2015
REC opinion
Further Information Favourable Opinion