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Proteasome Inhibitor
Daratumumab Combination Therapy for Multiple Myeloma
Phase 2
Waitlist Available
Led By Neha Korde, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females of childbearing potential (FCBP)† must meet specific pregnancy testing and birth control requirements
Specific criteria for hypercalcemia, anemia, bone disease, clonal bone marrow plasma cell percentage, involved/un-involved serum free light chain ratio, focal lesion on MRI, creatinine clearance, age, ECOG performance status, ANC, hemoglobin, platelet count, hepatic function, and thromboprophylactic strategies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial tests whether adding daratumumab to standard myeloma treatment is safe and improves outcomes.
Who is the study for?
This trial is for newly diagnosed multiple myeloma patients with measurable disease, specific organ damage, and certain blood and liver function levels. Participants must not have had more than one cycle of prior treatment. Women who can bear children and men must follow strict birth control rules.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of daratumumab combined with carfilzomib, lenalidomide, and dexamethasone in treating multiple myeloma. The goal is to determine if this drug mix is safe for patients.See study design
What are the potential side effects?
Possible side effects include immune system reactions, infusion-related reactions from daratumumab; blood clots or bone thinning from dexamethasone; kidney problems or low blood counts from lenalidomide; heart issues or lung complications from carfilzomib.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am using birth control and have had a recent negative pregnancy test.
Select...
My health status meets specific criteria related to blood, bone, kidney, liver conditions, and my physical ability.
Select...
I agree to use a latex condom during sex with a female capable of becoming pregnant.
Select...
My condition has caused damage to my organs or significant health events due to a plasma cell disorder.
Select...
I have been recently diagnosed with multiple myeloma.
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
assess the rate of MRD negativity
Side effects data
From 2020 Phase 1 & 2 trial • 22 Patients • NCT0284103386%
Diarrhea
82%
Cough
82%
Lymphocyte count decreased
77%
Creatinine Increased
73%
Fatigue
73%
Hypertriglyceridemia
68%
Anemia
64%
Hypermagnesemia
64%
Myalgia
64%
Headache
59%
Cholesterol high
59%
Hyperuricemia
59%
Nausea
55%
Back pain
55%
Insomnia
50%
Hypoalbuminemia
50%
Dizziness
50%
Chronic kidney disease
50%
Upper respiratory infection
45%
Sore throat
45%
Edema limbs
45%
Alkaline phosphatase increased
45%
Cardiac troponin I increased
45%
CPK increased
45%
Platelet count decreased
45%
Pain in extremity
45%
Bruising
41%
Nasal congestion
41%
Dyspnea
36%
Abdominal pain
36%
Constipation
36%
Paresthesia
36%
Vomiting
36%
Rhinitis infective
36%
Aspartate aminotransferase increased (AST)
36%
Hypophosphatemia
36%
Metabolic and nutrition disorders - other, specify: iron deficiency
32%
Rhinorrhea
32%
Abdominal distention
32%
Eye disorders - other, specify: subconjunctival hemorrhage
32%
Fever
32%
Arthalgia
32%
Neck pain
32%
Anorexia
32%
Hyponatremia
32%
Rash maculopapular
27%
Post nasal drip
27%
Productive cough
27%
Total bilirubin increased
27%
White blood cell decreased
27%
Hyperkalemia
27%
Hoarseness
23%
Neutrophil count decreased
23%
Hypoglycemia
23%
Hematuria
23%
Urinary frequency
23%
Hypercalcemia
18%
Atrial fibrillation
18%
Chills
18%
Musculoskeletal and connective tissue disorder - other, specify: Restless legs
18%
Hyperglycemia
18%
Epistaxis
14%
Hyperthyroidism
14%
Blurred vision
14%
Acute kidney injury
14%
Heart failure
14%
Lung infection
14%
Ear pain
14%
Tinnitus
14%
Localized Edema
14%
Hypocalcemia
14%
Flank pain
14%
Peripheral sensory neuropathy
14%
Nocturia
14%
Allergic Rhinitis
14%
Endocrine disorder - other, specify: TSH elevated
14%
Gastroesophageal Reflux
14%
Oral pain
14%
Sinusitis
14%
Pruritus
14%
Rash acneiform
14%
Skin and Subcutaneous tissue disorders - other, specify: bug bite
14%
Skin and Subcutaneous tissue disorders - other, specify: Laceration
14%
Hypertension
9%
Dysgeusia
9%
Congestion
9%
Conjunctivitis
9%
Alopecia
9%
Sepsis
9%
Syncope
9%
Palpitations
9%
Hearing loss
9%
Dry eye
9%
Flu like symptoms
9%
Fall
9%
Investigations - other, specify: Lactate dehydrogenase elevated
9%
Metabolic and nutrition disorders - other, specify: Type 2 diabetes mellitus
9%
Neck stiffness
9%
Proteinuria
9%
Gastrointestinal disorder - other, specify: Tooth extraction
9%
Gastrointestinal disorder - other, specify: inguinal hernia
9%
Serum amylase increased
9%
Weight gain
9%
Dehydration
9%
Metabolic and nutrition disorders - other, specify: increased appetite
9%
Tremor
9%
Anxiety
9%
Depression
9%
Dry Skin
9%
Nail infection
9%
Surgical procedure - other, specify: pre-cancerous areas removed
5%
Periorbital edema
5%
Cataract
5%
Eye disorders - other, specify: obstructive tear duct
5%
Eye disorders - other, specify: redness
5%
Eye disorders - other, specify: scleral abrasian
5%
Vaginal infection
5%
Alanine aminotransferase increased (ALTT)
5%
Wheezing
5%
Hypothyroidism
5%
Watering eyes
5%
Bloating
5%
Gastrointestinal hemorrhage - melena
5%
Myocardial infarction (NSTEMI)
5%
Renal and urinary disorders - other, UTI sepsis
5%
Thromboembolic event
5%
Upper gastrointestinal bleeding
5%
Urinary tract infection
5%
Urine output decreased
5%
Lymph node pain
5%
Chest pain - cardiac
5%
Vertigo
5%
Eye disorders - other, specify: cloudiness
5%
Eye disorders - other, specify: Scotoma
5%
Eye infection
5%
Floaters
5%
Anal hemorrhage
5%
Dental caries
5%
Dry mouth
5%
Flatulence
5%
Gait disturbance
5%
Cystitis non-infective
5%
Metabolic and nutrition disorders - other, specify: vitamin B12 deficiency
5%
Arthritis
5%
Generalized muscle weakness
5%
Muscle weakness lower limb
5%
Musculoskeletal and connective tissue disorder - other, specify: Dupuytren's contracture
5%
Neoplasms - other, specify: basal cell carcinoma on sternum
5%
Concentration impairment
5%
Dysphagia
5%
Memory impairment
5%
Nervous system disorders - Other, specify: Autonomic Postural Hypotension
5%
Irritability
5%
Urinary incontinence
5%
Urinary tract pain
5%
Urinary urgency
5%
Genital edema
5%
Bronchospasm
5%
Sleep apnea
5%
Hypotension
5%
CK increased
5%
Colitis
5%
Gastrointestinal disorder - other, specify: ulcer - Left lateral tongue
5%
Gastrointestinal disorder - other, specify: viral gastroenteritis
5%
Chest pain
5%
Chest pain - non cardiac
5%
Gastrointestinal disorder - other, specify: black stool
5%
Gastrointestinal disorder - other, specify: broken tooth
5%
Gastrointestinal disorder - other, specify: H. pylori
5%
Immune system disorders - other, specify: lymphadenopathy
5%
Laryngitis
5%
Pharyngitis
5%
Tooth infection
5%
Weight loss
5%
Hypokalemia
5%
Hypomagnesemia
5%
Agitation
5%
Confusion (forgetfullness)
5%
Mania
5%
Hiccups
5%
Hypoxia
5%
Laryngeal inflammation
5%
Photosensitivity
5%
Rash
5%
Skin & subcutaneous tissue disorders - other, specify: cercarial dermatitis/swimmer's itch
5%
Skin and Subcutaneous tissue disorders - other, specify: Abrasion
5%
Skin and Subcutaneous tissue disorders - other, specify: erythema
5%
Skin and subcutaneous tissue disorders - other, specify: Skin sensitivity
5%
Skin and Subcutaneous tissue disorders - other, specify: Wound
5%
Skin induration
5%
Surgical procedure - other, specify: Biopsy /wart removal
5%
Surgical procedure - other, specify: biopsy, face, head, back
5%
Surgical procedure - other, specify: shaved excision of dysplastic nevus
5%
Arterial injury
5%
Hot flashes
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daratumumab
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment4 Interventions
Single arm, two-stage phase II trial of combination therapy (daratumumab, carfilzomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients. Patients achieving ≥PR at end of 4 cycles will continue to receive the planned total of 8 cycles of combination therapy. Patients may go onto receiving additional maintenance phase therapy with lenalidomide under a separate treatment protocol. Patients ≤ PR after completing 4 cycles will go off study therapy.
Group II: Cohort 1Experimental Treatment4 Interventions
Single arm, two-stage phase II trial of combination therapy (daratumumab, carfilzomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients. Patients achieving ≥PR at end of 4 cycles will continue to receive the planned total of 8 cycles of combination therapy. Patients may go onto receiving additional maintenance phase therapy with lenalidomide under a separate treatment protocol. Patients ≤ PR after completing 4 cycles will go off study therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
daratumumab
2017
Completed Phase 2
~60
dexamethasone
1995
Completed Phase 3
~9860
lenalidomide
2012
Completed Phase 3
~3920
carfilzomib
2010
Completed Phase 2
~710
Find a Location
Who is running the clinical trial?
Janssen PharmaceuticalsIndustry Sponsor
80 Previous Clinical Trials
204,996 Total Patients Enrolled
11 Trials studying Multiple Myeloma
657 Patients Enrolled for Multiple Myeloma
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,545 Total Patients Enrolled
80 Trials studying Multiple Myeloma
86,092 Patients Enrolled for Multiple Myeloma
Neha Korde, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
127 Total Patients Enrolled
3 Trials studying Multiple Myeloma
127 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using birth control and have had a recent negative pregnancy test.My health status meets specific criteria related to blood, bone, kidney, liver conditions, and my physical ability.I do not have specific conditions like uncontrolled diabetes, heart disease, or recent major surgery.You have a specific type of disease that has been measured within the past 4 weeks using specific tests for proteins in the blood and urine, as well as any related organ damage.I have received more than one cycle of treatment for multiple myeloma.I agree to use a latex condom during sex with a female capable of becoming pregnant.My condition has caused damage to my organs or significant health events due to a plasma cell disorder.I have been recently diagnosed with multiple myeloma.I have followed the required break period after my last treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
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.
Has the efficacy of daratumumab been tested in other clinical trials?
"Research into daratumumab began in 2002 at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. To date, 1391 studies have been concluded and a further 752 are still ongoing, many of which are being conducted from Commack, New jersey."
Answered by AI
What diseases does daratumumab typically serve to remedy?
"Ophthalmia, sympathetic can often be managed through the use of daratumumab. Additionally, this drug has also been found to treat branch retinal vein occlusion, macular edema and those who have already undergone two rounds of systemic chemotherapy."
Answered by AI
How many health facilities are conducing this clinical research?
"As it stands, 7 medical facilities are hosting this particular trial. These sites can be found in Commack, Middletown and Basking Ridge as well other cities around the US. To make participation easier on you, try to select a location closest your current residence or place of work."
Answered by AI
Are there any open spots in this experiment at the present moment?
"No longer recruiting, this trial was initially posted on September 25th 2017 and last updated November 17 2022. Currently, there are 807 studies involving multiple myeloma accepting patients as welll as 752 trials for participants with daratumumab."
Answered by AI
Does the administration of daratumumab confer any risks to humans?
"Daratumumab has been judged to have a safety rating of 2. This is because while there are some data points that demonstrate its safety, efficacy remains unconfirmed as this trial only just entered Phase 2."
Answered by AI
What is the enrollment rate for this trial's participants?
"As of November 17th 2022, this trial has stopped accepting new patients. It first appeared on September 25 2017 and was last updated a few weeks ago. If you are interested in similar studies though, 807 trials for multiple myeloma and 752 for daratumumab are still enrolling participants."
Answered by AI
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