Study of Melphalan Flufenamide (Melflufen) + Dex With Bortezomib or Daratumumab in Patients With RRMM

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Oncopeptides AB
Study ID
NCT03481556
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Melphalan flufenamide (Melflufen) — DRUG
    Intravenous infusion
  • Dexamethasone — DRUG
    Oral tablets
  • Bortezomib — DRUG
    Subcutaneous administration
  • Daratumumab — DRUG
    Intravenous infusion

Study Details

This is an open-label Phase 1/2a study which will enroll patients that have relapsed or relapsed-refractory multiple myeloma to combination regimens of melflufen with currently approved agents. Patients will receive either melflufen+dexamethasone+bortezomib or melflufen+dexamethasone+daratumumab.

Key Dates

Start date
Apr 12, 2018
Status verified
Dec 2022
Primary completion
Feb 2, 2022
Completion
Feb 2, 2022

Study Design

Enrollment
56 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A (melflufen+bortezomib+dex)
    Melflufen 30 mg and 40 mg or 20 mg i.v. Day 1 of each 28-day cycle in combination with bortezomib at 1.3mg/m² S.Q. on Days 1, 4, 8, 11 and dexamethasone 20 mg (12 mg ≥ 75 years) Days 1, 4, 8, 11 and 40 mg (20 mg ≥ 75 years) on Day 15 and 22 of each 28-day cycle.
  • Experimental: B (melflufen+daratumumab+dex)
    Melflufen 30 mg and 40 mg or 20 mg i.v. Day 1 of each 28-day cycle in combination with daratumumab 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Dexamethasone p.o. 40 mg weekly (20 mg weekly for patients age ≥ 75 years).

Primary Outcome Measure

Phase 1: Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) [ Time Frame: Cycle 1: Day 1 to Day 28 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-
The Ohio State UniversityColumbusOhio43210-

Find similar trials in Boston, MA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Dana Farber Cancer Institute· Boston, MAThe Ohio State University· Columbus, OH

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