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Monoclonal Antibodies

Carfilzomib 20 mg/m^2 for Multiple Myeloma

Phase 2

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to end of study; up to 30.3 months

Awards & highlights

Study Summary

This trial will compare the effectiveness of daratumumab, carfilzomib, and dexamethasone to just carfilzomib and dexamethasone in people with multiple myeloma who have relapsed or become refractory to treatment.

Eligible Conditions

Multiple Myeloma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to end of study; up to 30.3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to end of study; up to 30.3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to end of study; up to 30.3 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Percentage of Participants Achieving Very Good Partial Response (VGPR) or Better Response

Secondary outcome measures

Number of Participants With Anti-Daratumumab Antibodies

Number of Participants With Anti-recombinant Human Hyaluronidase (rHuPH20) Antibodies

Overall Response Rate (ORR)

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B: Dara-SC in combination with Kd (DKd)Experimental Treatment5 Interventions

Participants will receive daratumumab subcutaneous (Dara-SC) 1800 mg by SC injection on Days 1, 8, 15, 22 for Cycle 1 and 2, Days 1 and 15 for Cycle 3-6, Day 1 for Cycle 7 onwards. Participants will receive carfilzomib 20 mg/m^2 IV on Cycle 1 Day 1 and then 70 mg/m^2 on Day 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2. Participants will receive dexamethasone 20 mg on Cycle 1 Day 1, a second dose of 20 milligram (mg) will be given on Cycle 1 Day 2 and 40 mg IV or orally on Days 8, 15, 22 for Cycle 1. Patients will then receive dexamethasone 40mg on days 1, 8, 15 and 22 for cycles 2-9, then on Days 1, 8, 15 for Cycle 10 onwards, until death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study. The total duration of each cycle is 28 Days.

Group II: Arm A: Carfilzomib+Dexamethasone (Kd)Active Control4 Interventions

Participants will receive carfilzomib 20 milligram per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1 and then 70 mg/m^2 on Days 8 and 15 of Cycle 1 and thereafter on Days 1, 8, 15 of Cycle 2 onwards. Participants will receive dexamethasone 20 mg on Cycle 1 Day 1, a second dose of 20 milligram (mg) will be given on Cycle 1 Day 2 and 40 mg IV or orally on Days 8, 15, 22 for Cycle 1. Patients will then receive dexamethasone 40mg on days 1, 8, 15 and 22 for cycles 2-9, then on Days 1, 8, 15 for Cycle 10 onwards, until death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study. The total duration of each cycle is 28 Days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone 40 mg

2008

Completed Phase 2

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,220 Total Patients Enrolled

70 Trials studying Multiple Myeloma

19,329 Patients Enrolled for Multiple Myeloma

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

745 Previous Clinical Trials

3,959,817 Total Patients Enrolled

49 Trials studying Multiple Myeloma

14,296 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

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

Are there any other places in the US where this trial is occurring?

"There are 5 sites conducting this trial presently. They are based in Dallas, Calgary and Whittier as well as 2 other cities. If you enroll, it would be beneficial to choose the centre that is closest to your home to minimize travel time and costs."

Answered by AI

For what medical conditions is Carfilzomib 20 mg/m^2 often prescribed?

"Carfilzomib 20 mg/m^2 is frequently used to treat ophthalmia, sympathetic. Additionally, Carfilzomib 20 mg/m^2 has been found to be an effective treatment for branch retinal vein occlusion, macular edema, and communicable diseases."

Answered by AI

What scientific literature is available on Carfilzomib 20 mg/m^2?

"Carfilzomib 20 mg/m^2 was first trialled in 2002 at the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. So far, there have been 1,126 completed studies with 592 clinical trials still recruiting patients. A large number of these active trials are based out of Dallas, Texas."

Answered by AI

Has the FDA given Carfilzomib 20 mg/m^2 its stamp of approval?

"Because there is only some data supporting Carfilzomib 20 mg/m^2's safety and none of its efficacy, our team rates it as a 2."

Answered by AI

Could you please tell me if this research is still enrolling individuals?

"That is correct, the online information regarding this clinical trial confirms that it is searching for volunteers. This specific study was first advertised on 5/31/2019 and has since been updated on 11/3/2022. In total, 230 individuals are needed from 5 different locations."

Answered by AI

How many people are actively enrolled in this clinical trial at the moment?

"In order to run this trial, we need 230 patients that meet the specified inclusion criteria. These candidates can be recruited from multiple locations including Baylor Scott and White Health in Dallas, Texas and Tom Baker Cancer Centre in Calgary, Alberta."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab

2019. "Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03871829.