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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
Must not have
Subject has immeasurable MM
Subject has known HIV infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of study drug until first incidence of progression, up to 1222 days.
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My multiple myeloma has never been treated.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My multiple myeloma cannot be measured by standard tests.
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I am HIV positive.
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I do not have any infections or health issues that would make this treatment too risky for me.
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I am currently pregnant or breastfeeding.
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I have a heart condition.
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I have an active hepatitis B or C infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of study drug until first incidence of progression, up to 1222 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of study drug until first incidence of progression, up to 1222 days. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Response to Car-BiRD Treatment.
Secondary study objectives
Event Free Survival
MRD Negativity Following CarBiRD Regimen
Progression Free Survival
+1 more

Side effects data

From 2017 Phase 1 & 2 trial • 64 Patients • NCT01057225
80%
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%
Dyspnea
20%
Nausea
20%
Somnolence
17%
Malaise
16%
Hypokalemia
16%
Diarrhea
14%
Hyponatremia
14%
Hypophosphatemia
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%
Cough
6%
Lymphocyte count increased
6%
Hypoalbuminemia
6%
Lung infection
6%
Hyperkalemia
6%
Thromboembolic event
6%
Pain in extremity
6%
Tremor
6%
Insomnia
5%
Abdominal pain
5%
Gastrointestinal disorders - Other, specify
5%
Chills
5%
Vomiting
5%
Upper respiratory infection
5%
Heart failure
5%
Dehydration
5%
Myalgia
3%
Generalized muscle weakness
3%
Abdominal distension
3%
Syncope
3%
Chest pain - cardiac
3%
Hypotension
3%
Gastroesophageal reflux disease
3%
Dry mouth
3%
Acute kidney injury
3%
Investigations - Other, specify
3%
Sinus bradycardia
3%
Edema trunk
3%
Irritability
3%
Urinary tract infection
3%
Pulmonary hypertension
3%
Hypertriglyceridemia
3%
Musculoskeletal and connective tissue disorder - Other, specify
3%
Dysgeusia
3%
Renal and urinary disorders - Other, specify
2%
Flatulence
2%
Esophageal pain
2%
Infusion related reaction
2%
Memory impairment
2%
Mucositis oral
2%
Genital edema
2%
Back pain
2%
Urinary incontinence
2%
Multi-organ failure
2%
Leukocytosis
2%
Agitation
2%
Dyspepsia
2%
Urinary frequency
2%
Nervous system disorders - Other, specify
2%
Infections and infestations - Other, specify
2%
Cushingoid
2%
Metabolism and nutrition disorders - Other, specify
2%
Wound infection
2%
Surgical and medical procedures - Other, specify
2%
Epistaxis
2%
Tumor lysis syndrome
2%
Arthralgia
2%
Chest wall pain
2%
Apnea
2%
Febrile neutropenia
2%
Atrial fibrillation
2%
Conduction disorder
2%
Ventricular tachycardia
2%
Eye disorders - Other, specify
2%
Lower gastrointestinal hemorrhage
2%
Myocardial infarction
2%
Palpitations
2%
Paroxysmal atrial tachycardia
2%
Hearing impaired
2%
Gait disturbance
2%
General disorders and administration site conditions - Other, specify
2%
Pain
2%
Allergic reaction
2%
Weight gain
2%
Glucose intolerance
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

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: 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
~2240
carfilzomib
2010
Completed Phase 2
~710
Dexamethasone
2007
Completed Phase 4
~2650
Clarithromycin
2017
Completed Phase 4
~3950

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,092 Previous Clinical Trials
1,154,712 Total Patients Enrolled
19 Trials studying Multiple Myeloma
592 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
Ruben Niesvizky, M.D.Principal InvestigatorWeill Medical College of Cornell University
Jorge Monge, M.D.Principal InvestigatorWeill Medical College of Cornell University

Media Library

Carfilzomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01559935 — Phase 2
Multiple Myeloma Research Study Groups: Car-BiRD Therapy
Multiple Myeloma Clinical Trial 2023: Carfilzomib Highlights & Side Effects. Trial Name: NCT01559935 — Phase 2
Carfilzomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01559935 — Phase 2
~5 spots leftby Dec 2025
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