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Monoclonal Antibodies

Daratumumab for Multiple Myeloma

Phase 2
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of smoldering multiple myeloma (SMM) for less than 5 years
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug on patients with a specific type of blood cancer.

Who is the study for?
This trial is for people who've been diagnosed with Smoldering Multiple Myeloma (SMM) within the last 5 years and are at intermediate or high risk. They should be relatively healthy, able to perform daily activities without significant assistance (ECOG score of 0 or 1). People can't join if they have other serious health issues, need treatment for active multiple myeloma, have had certain cancer treatments recently, or have a history of severe lung conditions.Check my eligibility
What is being tested?
The study is testing three different schedules for administering Daratumumab to see which one works best for patients with SMM. Daratumumab is an antibody that targets specific cells in the body's immune system that are involved in the development of multiple myeloma.See study design
What are the potential side effects?
Daratumumab may cause side effects such as infusion reactions (symptoms like fever and chills during administration), fatigue, nausea, back pain, cough and shortness of breath. It can also affect blood cell counts leading to increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was diagnosed with smoldering multiple myeloma less than 5 years ago.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My condition is diagnosed as intermediate or high-risk smoldering multiple myeloma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The percentage of participants that have an event (disease progression or death) per patient-year
The percentage of participants who achieve a complete response (CR)
Secondary outcome measures
Overall survival rate
Response to first subsequent multiple myeloma treatment
The median time of progression free survival (PFS)
+4 more

Side effects data

From 2020 Phase 1 & 2 trial • 22 Patients • NCT02841033
86%
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

3Treatment groups
Experimental Treatment
Group I: Arm C (Short Intense)Experimental Treatment1 Intervention
Group II: Arm B (Intermediate)Experimental Treatment1 Intervention
Group III: Arm A (Long Intense)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
daratumumab
2017
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
973 Previous Clinical Trials
6,383,672 Total Patients Enrolled
69 Trials studying Multiple Myeloma
19,258 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,785 Total Patients Enrolled
49 Trials studying Multiple Myeloma
14,263 Patients Enrolled for Multiple Myeloma

Media Library

Daratumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02316106 — Phase 2
Multiple Myeloma Research Study Groups: Arm A (Long Intense), Arm C (Short Intense), Arm B (Intermediate)
Multiple Myeloma Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT02316106 — Phase 2
Daratumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02316106 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How widespread is this trial's implementation?

"This research trial is being administered at 18 sites across the country, including major cities like Cincinnati, Little Rock and Nashville. To keep travel to a minimum when participating in this study, please select the site closest to you."

Answered by AI

Could you provide an overview of the prior experiments involving daratumumab?

"Currently, there are 140 studies researching daratumumab. Of those active trials, 26 have been classified as Phase 3. The primary research hub is Harrison, New york; however, the drug's clinical trial presence spans 5561 different locations worldwide."

Answered by AI

Are there any available opportunities for recruitment into this trial?

"According to the records on clinicaltrials.gov, this trial has concluded its search for participants and is no longer recruiting applications. The initial posting of this research was made on May 20th 2015, with a final update taking place November 3rd 2022. Despite the status quo of this study, there are still 948 other medical trials that are actively searching for volunteers at present time."

Answered by AI

How many subjects are participating in this clinical investigation?

"Unfortunately, recruitment for this clinical trial has ceased. It was initially posted on May 20th 2015 and last updated November 3rd 2022. However, there are 808 trials enrolling patients with multiple myeloma and 140 daratumumab studies currently admitting participants."

Answered by AI

What evidence is there to suggest that daratumumab has a low risk of adverse effects?

"Our team at Power assigned daratumumab a safety rating of 2, as the data for this Phase 2 trial suggests it is safe to use but does not demonstrate efficacy."

Answered by AI

What medical conditions are most often treated with daratumumab?

"Daratumumab is typically prescribed as a biological response modifier. Additionally, it can be employed to combat cases of refractory multiple myeloma, relapsed or refractory multiple myeloma, and in conjunction with cell transplants."

Answered by AI
~13 spots leftby Mar 2025