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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
Must not have
Active and/or progressive additional malignancy
Exposure to any investigational drug or invasive investigational medical device within 4 weeks or 5 pharmacokinetic half-lives prior to day 1 of treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to completion of induction; evaluated for approximately 32 weeks (8 28-day cycles).
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I have been active and mostly self-sufficient in the last 28 days.
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I am committed to using two effective birth control methods.
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I am 18 years old or older.
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I have been newly diagnosed with multiple myeloma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have another cancer that is growing or spreading.
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I haven't used any experimental drugs or devices within the last 4 weeks.
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I have had a stroke with lasting effects.
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I have not had major surgery in the last 2 weeks.
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I do not have any unmanaged serious illnesses.
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I am currently on medication for an infection.
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My lung function is less than half of what is expected for someone my age and size.
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I have not had targeted radiation therapy in the last 14 days.
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My multiple myeloma has spread to my brain or spinal cord.
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My multiple myeloma does not produce detectable levels of M protein.
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I have been treated with daratumumab or similar medications before.
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I am over 70 and considered too frail for a transplant.
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I have been diagnosed with POEMS syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to best response determined at the end of induction (8 28-day cycles); the median length of induction was 32 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to best response determined at the end of induction (8 28-day cycles); the median length of induction was 32 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Complete Response or Stringent Complete Response to Induction
Secondary study objectives
Duration of Response (DoR)
Number of Participants With an Objective Response (OR)
Overall Survival (OS)
+3 more
Other study objectives
Daratumumab Administration - Number of Cycles Received
Daratumumab Administration - Number of Doses Received
Number of Participants Who Discontinued Study Treatment Due to Adverse Events
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,397 Previous Clinical Trials
2,460,090 Total Patients Enrolled
21 Trials studying Multiple Myeloma
4,946 Patients Enrolled for Multiple Myeloma
AmgenIndustry Sponsor
1,442 Previous Clinical Trials
1,397,705 Total Patients Enrolled
97 Trials studying Multiple Myeloma
20,726 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
Saad Z. Usmani, MDLead Sponsor
4 Previous Clinical Trials
27 Total Patients Enrolled
4 Trials studying Multiple Myeloma
27 Patients Enrolled for Multiple Myeloma
Janssen, LPIndustry Sponsor
168 Previous Clinical Trials
310,346 Total Patients Enrolled
25 Trials studying Multiple Myeloma
9,624 Patients Enrolled for Multiple Myeloma
CelgeneIndustry Sponsor
645 Previous Clinical Trials
130,144 Total Patients Enrolled
146 Trials studying Multiple Myeloma
41,767 Patients Enrolled for Multiple Myeloma
Saad Usmani, MDPrincipal InvestigatorAtrium Health
6 Previous Clinical Trials
348 Total Patients Enrolled
6 Trials studying Multiple Myeloma
348 Patients Enrolled for Multiple Myeloma
Manisha Bhutani, MDPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
1,680 Total Patients Enrolled
2 Trials studying Multiple Myeloma
1,680 Patients Enrolled for Multiple Myeloma

Media Library

Carfilzomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04113018 — Phase 2
Multiple Myeloma Research Study Groups: KRd-Daratumumab
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
~7 spots leftby Dec 2025
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