Carfilzomib, Iberdomide (CC-220) and Dexamethasone (KID) in Transplant Eligible Multiple Myeloma

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Hackensack Meridian Health
Study ID
NCT05199311
Phase
PHASE1/PHASE2
Status
Suspended

Conditions

Eligibility Criteria

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

Interventions

  • Carfilzomib — DRUG
    20 mg/m2 C1D1; 56 mg/m2 thereafter
  • Iberdomide — DRUG
    Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle
  • Oral Dexamethasone — DRUG
    40 mg (\<=75 years old); 20 mg (\>75 years old)

Study Details

This is a multi-institution, open label, phase I/II study of Iberdomide, Carfilzomib, and dexamethasone (KID) in patients with newly diagnosed transplant eligible MM.

Key Dates

First listed
Jan 20, 2022
Start date
May 13, 2022
Status verified
Jul 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
66 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Starting Dose -1
    CC-220/Iberdomide: 1.1 mg \[CC-220 dosing schedule: daily for 21 days of each 28-day cycle\] Carfilzomib: 20 mg/m2 C1D1 56 mg/m2 thereafter \[Days 1, 8, 15 per 28-day cycle\] Dexamethasone: 40 mg (≤ 75 years) 20 mg (\> 75 years) \[Days 1, 8, 15, 22 per 28-day cycle\] Treatment will continue with carfilzomib, iberdomide, and dexamethasone for up to 4 cycles (28 days) at the physician's discretion followed by the Autologous Stem Cell Transplant. Patients will be followed every 3 months for up to 2 years, or until PD or the start of a new line of therapy.
  • Experimental: Dose Level 1
    CC-220/Iberdomide: 1.3 mg \[CC-220 dosing schedule: daily for 21 days of each 28-day cycle\] Carfilzomib: 20 mg/m2 C1D1 56 mg/m2 thereafter \[Days 1, 8, 15 per 28-day cycle\] CC-220 dose level 1 enrollment will occur following an independent safety review two months after the first 10 patients have completed at least 2 cycles of therapy at dose level -1. Dexamethasone: 40 mg (≤ 75 years) 20 mg (\> 75 years) \[Days 1, 8, 15, 22 per 28-day cycle\] Treatment will continue with carfilzomib, iberdomide, and dexamethasone for up to 4 cycles (28 days) at the physician's discretion followed by the Autologous Stem Cell Transplant. Patients will be followed every 3 months for up to 2 years, or until PD or the start of a new line of therapy.
  • Experimental: Dose Level 2
    CC-220/Iberdomide: 1.6 mg \[CC-220 dosing schedule: daily for 21 days of each 28-day cycle\] Carfilzomib: 20 mg/m2 C1D1 56 mg/m2 thereafter \[Days 1, 8, 15 per 28-day cycle\] CC-220 dose level 2 enrollment will occur following an independent safety review two months after the first 10 patients have completed at least 2 cycles of therapy at dose level 1. Dexamethasone: 40 mg (≤ 75 years) 20 mg (\> 75 years) \[Days 1, 8, 15, 22 per 28-day cycle\] Treatment will continue with carfilzomib, iberdomide, and dexamethasone for up to 4 cycles (28 days) at the physician's discretion followed by the Autologous Stem Cell Transplant. Patients will be followed every 3 months for up to 2 years, or until PD or the start of a new line of therapy.
  • Experimental: Dose Level -2
    CC-220/Iberdomide: 0.75 mg \[CC-220 dosing schedule: daily for 21 days of each 28-day cycle\] Carfilzomib: 20 mg/m2 C1D1 56 mg/m2 thereafter \[Days 1, 8, 15 per 28-day cycle\] Dexamethasone: 40 mg (≤ 75 years) 20 mg (\> 75 years) \[Days 1, 8, 15, 22 per 28-day cycle\] Treatment will continue with carfilzomib, iberdomide, and dexamethasone for up to 4 cycles (28 days) at the physician's discretion followed by the Autologous Stem Cell Transplant. Patients will be followed every 3 months for up to 2 years, or until PD or the start of a new line of therapy.

Primary Outcome Measure

Rate of treatment emergent adverse events (TEAEs) [ Time Frame: Measured after cycle 4 of induction KID (each cycle is 28 days) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007-
John Theurer Cancer CenterHackensackNew Jersey07601-

Find similar trials in Washington D.C., DC

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Lombardi Comprehensive Cancer Center· Washington D.C., DCJohn Theurer Cancer Center· Hackensack, NJ

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