Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following Lenalidomide-based Therapy in the First or Second Line Setting

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Celgene
Study ID
NCT01946477
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Pomalidomide — DRUG
  • Dexamethasone — DRUG
  • Daratumumab — DRUG

Study Details

This trial will evaluate the efficacy and safety of combination of pomalidomide (POM) and low-dose dexamethasone (LD-Dex) (Cohort A) or the combination of pomalidomide (POM) , daratumumab (DARA) and low-dose dexamethasone (LD-Dex) (Cohort B) in subjects with relapsed or refractory multiple myeloma who have received a first or second line treatment of lenalidomide-based therapy. This trial will test the hypothesis for Cohort A that the proportion of patients will have an Overall Response Rate (ORR) of \> 30 % to reveal that Pomalidomide is efficacious in pretreated patients who are refractory to lenalidomide. This trial will test the hypothesis for Cohort B that the proportion of patients will have an Overall Response Rate (ORR) of \> 70 % to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide. This trial will test the hypothesis for Cohort C that the proportion of patients will have an Overall Response Rate (ORR) of \>60% to reveal that POM+DARA+LD-Dex is efficacious in pretreated patients who are refractory to lenalidomide. This treatment will be in only Japanese patients.

Key Dates

Start date
May 29, 2014
Status verified
May 2026
Primary completion
Apr 30, 2025
Completion
May 26, 2025

Study Design

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

Arms

  • Experimental: Pomalidomide + dexamethasone
    Each subject enrolled in the study will take oral pomalidomide (4 mg) once daily on Days 1-21 and dexamethasone 40 mg/day (\< 75 years old) or 20 mg/day (\>75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle.
  • Experimental: Pomalidomide + Dexamethasone + Daratumumab
    Each subject enrolled in the study will take oral pomalidomide (4 mg) once daily on Days 1-21 and dexamethasone 40 mg/day (\< 75 years old) or 20 mg/ day (\>75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle and daratumumab administered intravenously (IV) at a starting dose of 16 mg/kg at following schedule: * Days 1, 8, 15, and 22 of a 28-day cycle for Cycle 1 and Cycle 2 * Days 1 and 15 for Cycle 3 through Cycle 6 * Day 1 for Cycle 7 and each cycle thereafter until disease progression

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: From first dose until disease progression or end of treatment whichever occurs first (Up to 130 months) ]

Locations (33)

FacilityCityStateZIPSite coordinators
Local Institution - 126TucsonArizona85724-
Local Institution - 137GreenbraeCalifornia94904-2007-
Local Institution - 109Los AngelesCalifornia90095-1670-
Local Institution - 104Pleasant HillCalifornia94523-
Local Institution - 108WhittierCalifornia90603-
Local Institution - 138DenverColorado80218-
Local Institution - 120StamfordConnecticut06902-
Local Institution - 145JacksonvilleFlorida32256-
Local Institution - 127OrlandoFlorida32804-
Local Institution - 133Pembroke PinesFlorida33028-
Local Institution - 136St. PetersburgFlorida33705-
Local Institution - 134FairwayKansas66205-
Local Institution - 142TopekaKansas66606-
Local Institution - 124LouisvilleKentucky40207-
Local Institution - 103WestminsterMaryland21157-
Local Institution - 146Gross PointeMichigan48236-
Local Institution - 102Kansas CityMissouri64111-
Local Institution - 110St LouisMissouri63110-
Local Institution - 118East OrangeNew Jersey07018-
Local Institution - 101HackensackNew Jersey07601-
Local Institution - 129Glens FallsNew York12801-
Local Institution - 149The BronxNew York10467-
Local Institution - 130DurhamNorth Carolina27705-
Local Institution - 115ClevelandOhio44195-
Local Institution - 121ClevelandOhio44111-
Local Institution - 123ClevelandOhio44106-
Local Institution - 122Mayfield HeightsOhio44124-
Local Institution - 107HersheyPennsylvania17033-0850-
Local Institution - 135ChattanoogaTennessee37404-
Local Institution - 131NashvilleTennessee37203-
Local Institution - 128LubbockTexas79410-
Local Institution - 143PlanoTexas75093-
Local Institution - 106SpokaneWashington99218-

Find similar trials in Tucson, AZ

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Local Institution - 126· Tucson, AZLocal Institution - 137· Greenbrae, CALocal Institution - 109· Los Angeles, CALocal Institution - 104· Pleasant Hill, CALocal Institution - 108· Whittier, CALocal Institution - 138· Denver, CO

Related Studies