MUK Nine b: OPTIMUM Treatment Protocol

Sponsor
University of Leeds
Study ID
NCT03188172
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Chemotherapy
  • Bortezomib — DRUG
    Chemotherapy
  • Lenalidomide — DRUG
    Chemotherapy
  • Daratumumab — DRUG
    Chemotherapy
  • Dexamethasone — DRUG
    Chemotherapy
  • Melphalan — DRUG
    Chemotherapy
  • Filgrastim — DRUG
    Haematopoietic agent for the stem cell harvest

Study Details

To determine whether a combination of four novel agents bortezomib(Velcade), lenalidomide (Revlimid), Daratumumab (Darzalex) \& dexamethasone in combination with low-dose cyclophosphamide is sufficiently active in a high risk population of myeloma patients, to take forward into a phase III trial compared to standard treatment.

Key Dates

Start date
Sep 28, 2017
Status verified
May 2024
Primary completion
Oct 1, 2025
Completion
May 31, 2026

Study Design

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

Arms

  • Experimental: Trial Treatment
    Induction: Cyclophosphamide 500mg, days 1, 8 Bortezomib 1.3mg/m2, days 1, 4, 8, 11 Lenalidomide 25mg, days 1-14 Daratumumab 16mg/kg, days 1, 8, 15 (cycles 1\& 2), day 1 only from cycle 3 Dexamethasone 20-40mg, days 1, 4, 8, 11 ASCT stem cell harvest: with Bortezomib 1.3mg/m2, (12 hours post melphalan) Bortezomib 1.3mg/m2, day +5, +14, weekly Consolidation part 1: Bortezomib 1.3mg/m2 days 1, 8, 15, 22 Lenalidomide 25mg days 1-21 Daratumumab 16mg/kg day 1 Dexamethasone 20-40mg days 1, 8, 15, 22 Consolidation part 2: Bortezomib 1.3mg/m2 days 1, 8, 15 Lenalidomide 25mg days 1-21 Daratumumab 16mg/kg day 1 Maintenance: Lenalidomide 10mg days 1-21 Daratumumab 16mg/kg day 1

Primary Outcome Measure

Progression free survival [ Time Frame: At 18 months post registration ]

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