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Proteasome Inhibitor

Daratumumab + KRd for Multiple Myeloma

Phase 2
Waitlist Available
Led By Saad Usmani, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 within 28 days prior to day 1 of treatment
FCBP must be willing to use a highly effective contraceptive method plus a second contraceptive method
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to best response while on treatment (subjects on induction treatment for approximately 32 weeks)
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat Multiple Myeloma, which is a cancer of the plasma cells. The drugs work together to attack the cancer cells and destroy them. This new combination has shown to be effective in subjects with MM in preliminary trials.

Who is the study for?
This trial is for adults over 18 with newly diagnosed multiple myeloma. Participants must have good organ function, not be pregnant or breastfeeding, agree to use effective contraception methods, and cannot have had more than one prior treatment cycle for MM. They should not have severe lung conditions, recent major surgery, other active cancers or certain infections.Check my eligibility
What is being tested?
The study tests a combination of daratumumab with carfilzomib, lenalidomide and dexamethasone in new multiple myeloma cases. Daratumumab is an artificial protein that targets cancer cells and activates the immune system to fight them when combined with these medications.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system's activation such as flu-like symptoms, fatigue, nausea; possible blood disorders; increased risk of infections due to lowered immunity; and specific drug-related reactions which will vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I have been active and mostly self-sufficient in the last 28 days.
I am committed to using two effective birth control methods.
I am 18 years old or older.
I have been newly diagnosed with multiple myeloma.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to best response while on treatment (subjects on induction treatment for approximately 32 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to best response while on treatment (subjects on induction treatment for approximately 32 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Response
Secondary outcome measures
Duration of Response (DoR)
Overall Response (OR)
Overall Survival (OS)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
Induction: Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,240 Previous Clinical Trials
1,004,168 Total Patients Enrolled
17 Trials studying Multiple Myeloma
3,212 Patients Enrolled for Multiple Myeloma
AmgenIndustry Sponsor
1,370 Previous Clinical Trials
1,377,649 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,701 Patients Enrolled for Multiple Myeloma
Manisha BhutaniLead Sponsor
1 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Multiple Myeloma
15 Patients Enrolled for Multiple Myeloma

Media Library

Carfilzomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04113018 — Phase 2
Multiple Myeloma Research Study Groups: 1
Multiple Myeloma Clinical Trial 2023: Carfilzomib Highlights & Side Effects. Trial Name: NCT04113018 — Phase 2
Carfilzomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04113018 — Phase 2

Frequently Asked Questions

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

What treatments is the KRd + Daratumumab regimen typically prescribed for?

"Ocular inflammation, a sympathetic nervous system disorder, and retinal vein occlusion can be addressed with the combined treatment of Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab provided two earlier chemotherapy regimens have been tried."

Answered by AI

What are the results of previous investigations involving Carfilzomib, lenalidomide, dexamethasone (KRd) in conjunction with Daratumumab?

"Presently, there are 752 trials assessing the effects of Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab with 170 at Phase 3. While much research is conducted within Joliet Illinois, 26228 other clinical sites worldwide have launched investigations for this combination therapy."

Answered by AI

Is there availability for participants in this experiment?

"Unfortunately, this trial has ceased accepting candidates. It was first published on November 12th 2019 and last updated October 26th 2022. However, there are 807 clinical trials for multiple myeloma and 752 studies for Carfilzomib-lenalidomide-dexamethasone plus Daratumumab actively recruiting participants."

Answered by AI

How many participants have been recruited to participate in this clinical trial?

"This medical trial is no longer seeking enrolment. It first appeared on 11/12/2019, and the latest update was made 10/26/2022. However, there are 807 clinical trials actively recruiting participants with multiple myeloma, and 752 studies searching for individuals to participate in Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab treatments."

Answered by AI

Does the Food and Drug Administration (FDA) sanction Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab?

"Carfilzomib, lenalidomide and dexamethasone (KRd) in combination with Daratumumab has been evaluated for safety in clinical trials, awarding it a score of 2 on our scale. There remains no data confirming the efficacy of KRd + Dara as an intervention."

Answered by AI
~7 spots leftby Apr 2025