Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Andrew Yee, MD
Study ID
NCT04176718
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    predetermined dose, intravenously, at predetermined times per cycle
  • Carfilzomib — DRUG
    predetermined dose, intravenously, give 3 times per cycle
  • Pomalidomide — DRUG
    predetermined dose, orally, daily per cycle
  • Dexamethasone — DRUG
    predetermined dose, orally, given 8 times per cycle

Study Details

This research study is studying the combination of daratumumab with weekly carfilzomib, pomalidomide, and dexamethasone in people with relapsed and refractory multiple myeloma. Relapsed and Refractory Multiple Myeloma is the condition of returned or previous treatment resistant Multiple Myeloma. This research study involves two study drugs and two standard of care drugs. * The names of the study drugs involved in this study are: * Carfilzomib * Daratumumab * The names of the standard of care drugs involved in this study are: * Dexamethasone * Pomalidomide

Key Dates

Start date
May 18, 2020
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
44 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Daratumumab,Carfilzomib, Pomalidomide and Dexamethasone
    Patients who meet eligibility criteria for the study will subsequently be enrolled for treatment. Participants will receive daratumumab, carfilzomib, pomalidomide, and dexamethasone on a 28 day schedule. * Daratumumab will be given according to cycle and dosage determined by protocol. * Carfilzomib will be given at 56 mg/m2 on days 1, 8, 15 (except for C1D1 where it is 20 mg/m2) * Pomalidomide will be given daily on days 1-21. * Dexamethasone will be given weekly, split over two days.

Primary Outcome Measure

Objective response rate of the daratumumab, carfilzomib, pomalidomide, and dexamethasone combination [ Time Frame: 28 Days ]

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02155-
Massachusetts General HospitalBostonMassachusetts02115-

Find similar trials in Boston, MA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Beth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA

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