Your session is about to expire
← Back to Search
Proteasome Inhibitor
Carfilzomib + Dexamethasone for Multiple Myeloma (CarBiRD Trial)
Phase 2
Waitlist Available
Led By Adriana Rossi, M.D.
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has histologically confirmed multiple myeloma that has never before been treated
Subject is ≥ 18 years at the time of signing the consent form
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of study drug until first incidence of progression, up to 1222 days.
Awards & highlights
CarBiRD Trial Summary
This trial will study carfilzomib in combination with dexamethasone as a possible treatment for newly diagnosed multiple myeloma.
Who is the study for?
This trial is for adults with newly diagnosed multiple myeloma who haven't had anti-myeloma therapy recently, except limited corticosteroids. Participants must have measurable disease, be able to perform daily activities at a certain level, take blood clot prevention medication, and comply with the RevAssist® program. Women of childbearing age must test negative for pregnancy and use birth control.Check my eligibility
What is being tested?
The study tests carfilzomib combined with dexamethasone in new multiple myeloma patients followed by clarithromycin (Biaxin®), lenalidomide (Revlimid®), and dexamethasone [BiRD] treatment then maintenance with lenalidomide alone to assess safety and effectiveness.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system, increased risk of infections due to lowered white blood cell counts, possible heart issues from carfilzomib, steroid-related side effects like elevated blood sugar from dexamethasone, and gastrointestinal disturbances.
CarBiRD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My multiple myeloma has never been treated.
Select...
I am 18 years old or older.
CarBiRD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of study drug until first incidence of progression, up to 1222 days.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of study drug until first incidence of progression, up to 1222 days.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response to Car-BiRD Treatment.
Secondary outcome measures
Event Free Survival
MRD Negativity Following CarBiRD Regimen
Progression Free Survival
+1 moreSide effects data
From 2017 Phase 1 & 2 trial • 64 Patients • NCT0105722580%
Fatigue
55%
Constipation
50%
Neutrophil count decreased
47%
Platelet count decreased
42%
White blood cell decreased
42%
Anemia
41%
Lymphocyte count decreased
38%
Creatinine increased
38%
Hyperglycemia
36%
Peripheral sensory neuropathy
25%
Lethargy
23%
Edema limbs
22%
Hypocalcemia
20%
Nausea
20%
Dyspnea
20%
Somnolence
17%
Malaise
16%
Diarrhea
16%
Hypokalemia
14%
Hypophosphatemia
14%
Hyponatremia
14%
Alkaline phosphatase increased
13%
Aspartate aminotransferase increased
11%
Headache
11%
Alanine aminotransferase increased
11%
Depressed level of consciousness
11%
Dizziness
9%
Anorexia
9%
Rash maculo-papular
8%
Fever
8%
Hyperuricemia
8%
Peripheral motor neuropathy
8%
Anxiety
8%
Hypertension
6%
Lymphocyte count increased
6%
Cough
6%
Hypoalbuminemia
6%
Lung infection
6%
Hyperkalemia
6%
Thromboembolic event
6%
Pain in extremity
6%
Tremor
6%
Insomnia
5%
Abdominal pain
5%
Vomiting
5%
Upper respiratory infection
5%
Chills
5%
Gastrointestinal disorders - Other, specify
5%
Heart failure
5%
Dehydration
5%
Myalgia
3%
Abdominal distension
3%
Edema trunk
3%
Syncope
3%
Chest pain - cardiac
3%
Dry mouth
3%
Urinary tract infection
3%
Irritability
3%
Gastroesophageal reflux disease
3%
Generalized muscle weakness
3%
Acute kidney injury
3%
Hypotension
3%
Sinus bradycardia
3%
Investigations - Other, specify
3%
Pulmonary hypertension
3%
Hypertriglyceridemia
3%
Musculoskeletal and connective tissue disorder - Other, specify
3%
Dysgeusia
3%
Renal and urinary disorders - Other, specify
2%
Dyspepsia
2%
Esophageal pain
2%
Allergic reaction
2%
Hearing impaired
2%
Metabolism and nutrition disorders - Other, specify
2%
Urinary frequency
2%
Arthralgia
2%
Paroxysmal atrial tachycardia
2%
Wound infection
2%
Tumor lysis syndrome
2%
Agitation
2%
Gait disturbance
2%
Epistaxis
2%
Weight gain
2%
Glucose intolerance
2%
Genital edema
2%
General disorders and administration site conditions - Other, specify
2%
Chest wall pain
2%
Pain
2%
Apnea
2%
Myocardial infarction
2%
Conduction disorder
2%
Flatulence
2%
Cushingoid
2%
Eye disorders - Other, specify
2%
Infusion related reaction
2%
Febrile neutropenia
2%
Ventricular tachycardia
2%
Lower gastrointestinal hemorrhage
2%
Infections and infestations - Other, specify
2%
Memory impairment
2%
Nervous system disorders - Other, specify
2%
Leukocytosis
2%
Surgical and medical procedures - Other, specify
2%
Mucositis oral
2%
Palpitations
2%
Urinary incontinence
2%
Atrial fibrillation
2%
Multi-organ failure
2%
Back pain
2%
Restrictive cardiomyopathy
2%
Immune system disorders - Other, specify
2%
Skin infection
2%
Adult respiratory distress syndrome
2%
Hypoxia
2%
Respiratory failure
2%
Hypercalcemia
2%
Hypermagnesemia
2%
Hypernatremia
2%
Urine output decreased
2%
Wheezing
2%
Floaters
2%
Blood bilirubin increased
2%
Muscle weakness lower limb
2%
Cognitive disturbance
2%
Seizure
2%
Delirium
2%
Depression
2%
Psychiatric disorders - Other, specify
2%
Bladder spasm
2%
Cystitis noninfective
2%
Productive cough
2%
Sore throat
2%
Alopecia
2%
Pruritus
2%
Skin and subcutaneous tissue disorders - Other, specify
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Treated Patients
CarBiRD Trial Design
1Treatment groups
Experimental Treatment
Group I: Car-BiRD TherapyExperimental Treatment4 Interventions
Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1480
carfilzomib
2010
Completed Phase 2
~710
Dexamethasone
2007
Completed Phase 4
~2590
Clarithromycin
2017
Completed Phase 4
~3950
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,454 Total Patients Enrolled
18 Trials studying Multiple Myeloma
697 Patients Enrolled for Multiple Myeloma
Onyx Therapeutics, Inc.Industry Sponsor
19 Previous Clinical Trials
1,204 Total Patients Enrolled
8 Trials studying Multiple Myeloma
383 Patients Enrolled for Multiple Myeloma
Adriana Rossi, M.D.Principal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
6 Total Patients Enrolled
1 Trials studying Multiple Myeloma
6 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Participants must have certain test results within a certain range.I haven't had myeloma treatment in the last 14 days, except for limited corticosteroids.I do not have any infections or health issues that would make this treatment too risky for me.I can take blood-thinning medication as required.I am currently pregnant or breastfeeding.My multiple myeloma has never been treated.My multiple myeloma cannot be measured by standard tests.I have a heart condition.I have had a blood clot in the last 4 weeks.I am HIV positive.You have a disease that can be measured using specific guidelines.I have been cancer-free for over 5 years, except for certain types.I can care for myself but cannot do normal activities or work.I have an active hepatitis B or C infection.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Car-BiRD Therapy
Awards:
This trial has 1 awards, including:- 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.
Carfilzomib is often used as a treatment for what type of illness?
"Carfilzomib is most often used to treat ophthalmia and sympathetic. However, it has also been taken to effectively manage branch retinal vein occlusion, macular edema, and at least two prior systemic chemotherapy regimens."
Answered by AI
Are people currently being sought out for this particular experiment?
"The study in question is not recruiting patients at this moment, as stated on clinicaltrials.gov. This trial was first posted on March 1st 2012 and was edited most recently on April 10th 2022. However, there are 1589 other trials that are actively recruiting patients right now."
Answered by AI
Has carfilzomib undergone FDA approval process?
"The Power team has rated carfilzomib's safety as a 2. In Phase 2 trials, there is typically some evidence of safety but no efficacy data yet."
Answered by AI
How many individuals are being observed in this clinical trial?
"Currently, this study is not looking for any new participants. It was originally posted on March 1st 2012 and received its latest update on April 10th 2022. However, there are 827 other trials actively recruiting patients with multiple myeloma and 762 carfilzomib clinical trials also searching for volunteers."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger