Your session is about to expire
← Back to Search
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
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Confirmed diagnosis of intermediate or high-risk SMM
Must not have
Active multiple myeloma requiring treatment as defined by the study protocol
Primary systemic AL (immunoglobulin light chain) amyloidosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing how often daratumumab should be given to patients with early-stage multiple myeloma at high risk of becoming active. The medication helps the immune system target and kill cancer cells. Daratumumab is a unique antibody approved for treating multiple myeloma.
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My multiple myeloma needs treatment.
Select...
I have been diagnosed with AL amyloidosis.
Select...
I have been diagnosed with COPD or severe asthma in the last 2 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The percentage of participants who achieve a complete response (CR)
Secondary study objectives
The median time of progression free survival (PFS)
The percentage of participants who achieve a Complete Response (CR) or a Partial Response (PR)
Time to next treatment (TNT)
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~180
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Multiple Myeloma treatments often involve monoclonal antibodies like Daratumumab, which target specific proteins on myeloma cells. Daratumumab binds to CD38, a protein highly expressed on myeloma cells, leading to immune-mediated destruction through mechanisms such as antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity.
This targeted approach helps to specifically eliminate myeloma cells while sparing normal cells, reducing side effects and improving patient outcomes. Other treatments, such as Elotuzumab and Isatuximab, also target surface proteins on myeloma cells to enhance immune response.
These therapies are crucial as they offer more effective and less toxic options for managing Multiple Myeloma, improving survival rates and quality of life for patients.
Monoclonal Antibodies in Cancer Therapy.CD38 expression and complement inhibitors affect response and resistance to daratumumab therapy in myeloma.
Monoclonal Antibodies in Cancer Therapy.CD38 expression and complement inhibitors affect response and resistance to daratumumab therapy in myeloma.
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
1,004 Previous Clinical Trials
6,398,184 Total Patients Enrolled
76 Trials studying Multiple Myeloma
19,990 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
770 Previous Clinical Trials
3,973,924 Total Patients Enrolled
53 Trials studying Multiple Myeloma
14,911 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't used specific myeloma treatments or high-dose steroids recently.My multiple myeloma needs treatment.I haven't had cancer, except for certain skin, cervical, or early-stage cancers, in the last 3 years.I was diagnosed with smoldering multiple myeloma less than 5 years ago.I have been diagnosed with AL amyloidosis.I have been diagnosed with COPD or severe asthma in the last 2 years.I am fully active or restricted in physically strenuous activity but can do light work.My condition is diagnosed as intermediate or high-risk smoldering multiple myeloma.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C (Short Intense)
- Group 2: Arm A (Long Intense)
- Group 3: Arm B (Intermediate)
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.
Share this study with friends
Copy Link
Messenger