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Proteasome Inhibitor
DKRd Regimen for Multiple Myeloma
Phase 2
Recruiting
Led By Andrzej Jakubowiak, MD, PhD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Woman of childbearing potential must have 2 negative pregnancy tests prior to initiating lenalidomide
Diagnosis of symptomatic multiple myeloma as per current International Myeloma Working Group (IMWG) uniform criteria prior to initial treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment regimen for multiple myeloma.
Who is the study for?
This trial is for adults with newly diagnosed, untreated multiple myeloma who need systemic chemotherapy. They must have measurable disease, good performance status (able to carry out daily activities), and proper liver function. Women of childbearing age must use two forms of contraception or abstain from sex, and men must use condoms. Participants cannot join if they have certain heart conditions, severe lung problems like COPD or asthma, recent major surgery, active infections requiring treatment within the last two weeks, or a history of other cancers in the past three years.Check my eligibility
What is being tested?
The study tests a combination therapy called D-KRd: daratumumab (an antibody that targets cancer cells), carfilzomib (a drug that disrupts cancer cell waste disposal), lenalidomide (which affects the immune system and can kill cancer cells) and low dose dexamethasone (a steroid to reduce inflammation). The response rate after eight cycles will be measured to see how well this regimen works against multiple myeloma.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site for daratumumab; heart issues and shortness of breath from carfilzomib; blood clots, fatigue, diarrhea from lenalidomide; and increased blood sugar levels due to dexamethasone. There may also be an increased risk of infection due to effects on white blood cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman who can have children and have had 2 negative pregnancy tests before starting lenalidomide.
Select...
I have been diagnosed with symptomatic multiple myeloma.
Select...
My bone marrow has more than 10% plasma cells or I have a confirmed plasmacytoma.
Select...
My kidney function is good, with a creatinine clearance rate of at least 50 mL/min or my serum creatinine is below 2 g/dL.
Select...
I have newly diagnosed myeloma and need chemotherapy.
Select...
I am fully active or have some restrictions but can still care for myself.
Select...
My liver tests are within the normal range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of minimal residual disease (MRD)-negative disease as assessed by Next Generation Sequencing
Rate of stringent complete response (sCR)
Secondary outcome measures
Duration of response
Long term rate of MRD-negative disease
Number of grade 2 or higher side effects as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 criteria
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment Arm (D-KRd)Experimental Treatment4 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
FDA approved
Carfilzomib
FDA approved
Daratumumab
FDA approved
Dexamethasone
FDA approved
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,702 Total Patients Enrolled
16 Trials studying Multiple Myeloma
1,894 Patients Enrolled for Multiple Myeloma
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,443 Total Patients Enrolled
23 Trials studying Multiple Myeloma
2,021 Patients Enrolled for Multiple Myeloma
AmgenIndustry Sponsor
1,371 Previous Clinical Trials
1,378,143 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,665 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a high level of protein in your urine.I will provide a bone marrow sample for the study.I am 18 years old or older.I am a woman who can have children and have had 2 negative pregnancy tests before starting lenalidomide.I haven't had a heart attack in the last 6 months and don't have severe heart issues.I have COPD with less than half the normal lung function.I have been diagnosed with plasma cell leukemia.I have Waldenström's macroglobulinemia or IgM myeloma.I haven't been in a drug study within the last 3 weeks or 5 drug half-lives.I have moderate to severe numbness, tingling, or pain in my hands or feet.I do not have an active HIV, HBV, or HCV infection, or I am only HBV positive due to vaccination.I haven't had cancer in the last 3 years, except for certain low-risk types or those considered cured by surgery.I have been diagnosed with symptomatic multiple myeloma.I agree to use a condom during the study and for 90 days after, even if I've had a vasectomy.My kidney function is good, with a creatinine clearance rate of at least 50 mL/min or my serum creatinine is below 2 g/dL.My blood pressure or diabetes is not well-managed.I have mild to no diarrhea without taking medication for it.My cancer has spread to my brain or spinal cord.I have not taken antibiotics, antivirals, or antifungals for an infection in the last two weeks.You have measurable levels of a specific protein in your blood according to current guidelines.My multiple myeloma does not show up in standard blood or urine tests.I have POEMS syndrome.I have been diagnosed with amyloidosis.My bone marrow has more than 10% plasma cells or I have a confirmed plasmacytoma.I've had treatments for myeloma complications but not beyond the specified limits.I cannot tolerate daratumumab, carfilzomib, lenalidomide, or dexamethasone.Your white blood cell count, red blood cell count, and platelet count are within certain healthy ranges.I have had moderate to severe asthma in the last 2 years or currently have uncontrolled asthma.Your heart's electrical activity (QT interval) is too long on a special heart test (ECG).I have newly diagnosed myeloma and need chemotherapy.I haven't had widespread radiotherapy or immunotherapy in the last 4 weeks.You have a detectable disease that can be measured before starting treatment.If the blood test for M-protein is not reliable, then we can use quantitative immunoglobulin levels instead.I agree to use two forms of birth control or abstain from sex while in the study.I have had a blood clot in my lung.I have been diagnosed with moderate or severe asthma or COPD.People who are frail and not eligible for organ transplants, as defined in a specific medical publication by Palumbo et al in 2015.You have signs that your disease is getting worse according to specific medical criteria.I am fully active or have some restrictions but can still care for myself.My liver tests are within the normal range.I have not had major surgery in the last 3 weeks.You have a high level of M-protein in your blood.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm (D-KRd)
Awards:
This trial has 3 awards, including:- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many enrolled participants are contributing to the data from this clinical trial?
"Yes, available information on clinicaltrials.gov confirms that this medical experiment is actively recruiting participants. It was initially published in February 13th 2019 and last modified on September 15th 2021. 75 volunteers are required for the trial, which will take place at a single site."
Answered by AI
What previous experiments have utilized Daratumumab as a means of treatment?
"Presently, there are 751 active trials researching Daratumumab with 170 of them having entered Phase 3. While most experiments are based in Mishawaka, Indiana, 26205 other areas feature daratumumab-related clinical studies."
Answered by AI
To what degree could Daratumumab be detrimental to someone's health?
"Daratumumab has been through a Phase 2 trial, so there is limited evidence of its safety. Our team at Power assigned it a score of 2 on the scale from 1 to 3."
Answered by AI
Does this research project still have room for participants?
"According to the clinicaltrials.gov portal, this experiment is actively recruiting participants. Initially posted on February 13th 2019 and modified lastly on September 15th 2021, it seeks eligible patients for enrolment."
Answered by AI
What conditions is Daratumumab commonly employed to address?
"Daratumumab is frequently prescribed to manage ophthalmia, sympathetic. Additionally, it has been used in conjunction with chemotherapy treatments and for the alleviation of branch retinal vein occlusion and macular edema symptoms."
Answered by AI
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