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Proteasome Inhibitor
KRd vs VRd Regimens for Multiple Myeloma ((COBRA) Trial)
Phase 3
Recruiting
Led By Andrzej Jakubowiak, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have received no prior radiotherapy to a large area of the pelvis (more than half of the pelvis)
Eastern Cooperative Oncology Group performance status of 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
(COBRA) Trial Summary
This trial will compare two different treatment regimens for newly diagnosed multiple myeloma patients.
Who is the study for?
This trial is for adults with newly diagnosed multiple myeloma who haven't had chemotherapy or extensive radiotherapy. They must not have used bortezomib or lenalidomide before and should be fit enough for potential future stem cell transplant, though it's deferred during the trial. Participants need functioning major organs, no severe heart conditions, and can't be pregnant. Women of childbearing potential must use two forms of contraception.Check my eligibility
What is being tested?
The study compares two drug combinations: Carfilzomib with Lenalidomide and Dexamethasone (KRd) versus Bortezomib with Lenalidomide and Dexamethasone (VRd). It aims to determine which regimen is more effective in treating patients who are new to treatment for multiple myeloma.See study design
What are the potential side effects?
Potential side effects include fatigue, nausea, low blood counts leading to increased infection risk or bleeding problems, nerve damage causing numbness or pain, liver issues reflected by abnormal blood tests, allergic reactions during infusion of drugs, and possible heart complications.
(COBRA) Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had radiation to more than half of my pelvis.
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I am fully active or can carry out light work.
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I have been diagnosed with symptomatic multiple myeloma.
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My bone marrow has more than 10% plasma cells or I have a confirmed plasmacytoma.
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I have newly diagnosed myeloma and need chemotherapy.
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My liver tests are within normal limits.
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I have never been treated with bortezomib or lenalidomide.
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My kidney function, measured by creatinine clearance, is normal or only slightly reduced.
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I have not received chemotherapy for my current illness.
(COBRA) Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with progression free survival with the group taking KRd versus VRd after randomization
Secondary outcome measures
Evaluate the correlation between treatment outcome using KRd or VRd and pre-treatment
The combination of drugs (KRd vs VRd) safety and tolerability based on patients response
The combination of drugs (KRd vs VRd) with the best response using minimal residual disease analysis across entire treatment in high risk and low risk patients
+1 more(COBRA) Trial Design
2Treatment groups
Experimental Treatment
Group I: VRD ArmExperimental Treatment3 Interventions
Patients assigned to this group will receive a combination of Bortezomib, lenalidomide and dexamethasone in 21-day cycles. Doses will vary
Group II: KRD ArmExperimental Treatment3 Interventions
Patients assigned to this group will receive a combination of carfilzomib, lenalidomide, and dexamethasone in 28 day cycles. Doses will vary
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carfilzomib
FDA approved
Bortezomib D-mannitol
FDA approved
Dexamethasone
FDA approved
Lenalidomide
FDA approved
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,527 Total Patients Enrolled
16 Trials studying Multiple Myeloma
1,719 Patients Enrolled for Multiple Myeloma
Andrzej Jakubowiak, MDPrincipal InvestigatorUniversity of Chicago
2 Previous Clinical Trials
103 Total Patients Enrolled
2 Trials studying Multiple Myeloma
103 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had radiation to more than half of my pelvis.I haven't had serious heart issues like uncontrolled chest pain or heart failure in the last 6 months.You have signs that your disease is getting worse according to specific guidelines.I have had a blood clot in my lungs before or currently.I have been diagnosed with moderate or severe asthma or COPD.My multiple myeloma does not produce much protein.I am fully active or can carry out light work.I haven't had a heart attack in the last 6 months and don't have severe heart issues.I have been diagnosed with amyloidosis.Your blood counts need to be within certain levels: white blood cells above 1.0, hemoglobin above 8, and platelets above 75.I do not have an active HIV, HBV (unless from vaccine), or HCV infection.I have been diagnosed with symptomatic multiple myeloma.I will provide a bone marrow sample for the study.My bone marrow has more than 10% plasma cells or I have a confirmed plasmacytoma.I haven't been in a drug study within the last 3 weeks or 5 drug half-lives.Your heart's electrical activity measured on an ECG shows a prolonged QT interval.My diabetes is not under control.I cannot tolerate certain cancer medications like daratumumab or lenalidomide.I am 18 years old or older.I cannot or do not want to take blood clot prevention medication.I have had 2 negative pregnancy tests before starting lenalidomide.I have mild to no diarrhea without taking medication for it.I have not taken antibiotics, antivirals, or antifungals for an infection in the last two weeks.I have newly diagnosed myeloma and need chemotherapy.I have taken steroids for no more than 2 weeks and not more than 160 mg of dexamethasone.My liver tests are within normal limits.I have POEMS syndrome.I will use a condom during the study and for 90 days after, even though I've had a vasectomy.I have never been treated with bortezomib or lenalidomide.I have Waldenström's macroglobulinemia or IgM myeloma.My cancer has spread to my brain or spinal cord.My kidney function, measured by creatinine clearance, is normal or only slightly reduced.People who are not strong enough for a transplant, as described in a specific medical article by Palumbo et al.I haven't had radiotherapy to multiple sites or immunotherapy within the last 4 weeks.I have been diagnosed with plasma cell leukemia.I haven't had cancer, except for certain types, in the last 3 years.I have not had major surgery in the last 3 weeks.I have not received chemotherapy for my current illness.You have a certain amount of abnormal protein in your blood or urine that can be measured.I have moderate to severe numbness, tingling, or pain in my hands or feet.
Research Study Groups:
This trial has the following groups:- Group 1: KRD Arm
- Group 2: VRD Arm
Awards:
This trial has 4 awards, including:- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
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.
Dexamethasone is most commonly given to treat which conditions?
"Dexamethasone is often used to treat ophthalmia, sympathetic, and other conditions such as branch retinal vein occlusion and macular edema."
Answered by AI
Has Dexamethasone been cleared by the FDA?
"Dexamethasone is a Phase 3 medication, so it has some efficacy data as well as multiple safety trials. We consider it to be safe and give it a score of 3."
Answered by AI
How many individuals are being tracked in this clinical trial?
"Yes, this is an ongoing study that is actively looking for patients. The latest update was on June 7th, 2021 and the trial is looking for 250 patients at 1 location."
Answered by AI
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