← Back to Search

Proteasome Inhibitor

Carfilzomib + Iberdomide + Dexamethasone for Multiple Myeloma

Phase 1 & 2

Waitlist Available

Led By Noa Biran, MD

Research Sponsored by Hackensack Meridian Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must have a documented diagnosis of MM and have measurable disease

Male subjects must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants will be followed for response assessment every 28 days until progression of disease or a subsequent myeloma regimen has been started. on treatment study duration will last up to 12 months; post treatment follow up will last up to two years.

Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat patients with newly diagnosed Multiple Myeloma who are eligible for a stem cell transplant.

Who is the study for?

This trial is for adults over 18 with newly diagnosed multiple myeloma who are eligible for a transplant. They must have measurable disease, be in good enough health to participate (ECOG score of 0-2), and agree to contraception or abstinence. High-risk patients should make up at least a quarter of participants. Those with severe medical conditions, prior malignancies within five years (except certain noninvasive ones), serious heart issues, uncontrolled diabetes or hypertension, HIV, active hepatitis, or significant neuropathy cannot join.Check my eligibility

What is being tested?

The study tests a combination therapy called KID—Carfilzomib (an intravenous drug), Iberdomide (a pill), and Dexamethasone (also oral)—on people with new multiple myeloma who can get transplants. It's an open-label phase I/II trial which means everyone knows what treatment they're getting and it aims to find the right dose and see how well it works.See study design

What are the potential side effects?

Possible side effects include reactions related to Carfilzomib infusions like fever or chills; steroid-related issues from Dexamethasone such as increased blood sugar levels; and effects from Iberdomide that could involve changes in blood counts leading to higher infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with multiple myeloma and it can be measured.

Select...

I am a male and will either not have sex or use a condom with women who can get pregnant.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

I agree not to donate blood or sperm while receiving the study treatment.

Select...

I have been recently diagnosed with multiple myeloma.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants will be followed for response assessment every 28 days until progression of disease or a subsequent myeloma regimen has been started. on treatment study duration will last up to 12 months; post treatment follow up will last up to two years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants will be followed for response assessment every 28 days until progression of disease or a subsequent myeloma regimen has been started. on treatment study duration will last up to 12 months; post treatment follow up will last up to two years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be followed for response assessment every 28 days until progression of disease or a subsequent myeloma regimen has been started. on treatment study duration will last up to 12 months; post treatment follow up will last up to two years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CR and sCR

Rate of treatment emergent adverse events (TEAEs)

Secondary outcome measures

Overall Response Rate (ORR)

Overall Survival (OS)

Progression Free Survival (PFS)

Trial Design

4Treatment groups

Experimental Treatment

Group I: Starting Dose -1Experimental Treatment3 Interventions

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.

Group II: Dose Level 2Experimental Treatment3 Interventions

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.

Group III: Dose Level 1Experimental Treatment3 Interventions

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.

Group IV: Dose Level -2Experimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oral Dexamethasone

2015

Completed Phase 3

~260

Iberdomide

2021

Completed Phase 1

~60

Carfilzomib

2017

Completed Phase 3

~1440

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hackensack Meridian HealthLead Sponsor

131 Previous Clinical Trials

28,178 Total Patients Enrolled

20 Trials studying Multiple Myeloma

1,354 Patients Enrolled for Multiple Myeloma

Noa Biran, MDPrincipal InvestigatorHackensack Meridian Health

3 Previous Clinical Trials

97 Total Patients Enrolled

3 Trials studying Multiple Myeloma

97 Patients Enrolled for Multiple Myeloma

Media Library

Carfilzomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05199311 — Phase 1 & 2

Multiple Myeloma Research Study Groups: Dose Level -2, Dose Level 2, Dose Level 1, Starting Dose -1

Multiple Myeloma Clinical Trial 2023: Carfilzomib Highlights & Side Effects. Trial Name: NCT05199311 — Phase 1 & 2

Carfilzomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05199311 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies in this research project for test subjects?

"That is correct, according to the information available on clinicaltrials.gov this study is open for recruitment. The trial was originally posted on May 13th, 2022 and was last edited June 10th, 2022. The researchers are looking for 66 participants at 1 location."

Answered by AI

How many people are currently enrolled in this trial?

"Yes, the most recent information available on clinicaltrials.gov indicates that this trial is still looking for participants. The posting was first made on May 13th, 2022 and updated June 10th, 2022. They are currently recruiting for 66 people at a single site."

Answered by AI