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

First listed
Mar 29, 2018
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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