Monoclonal Antibodies
Daratumumab for Multiple Myeloma
University of Rochester Medical Center, Rochester, NY
Daratumumab +2 morePhase 2RecruitingLed by Frank Passero, MDResearch Sponsored by University of RochesterEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate organ system function
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up28 days
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 60 Other Conditions
Study Summary
This trial will test the effectiveness of daratumumab and lenalidomide in treating multiple myeloma without the use of steroids.
Eligible Conditions
- Multiple Myeloma
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
Your organs are working well enough for you to participate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Daratumumab Related Infusion Reactions
Secondary outcome measures
Determination of Response Rates
Side effects data
From 2022 Phase 3 trial • 466 Patients • NCT0315868839%
Thrombocytopenia
37%
Hypertension
37%
Anaemia
36%
Diarrhoea
34%
Upper respiratory tract infection
26%
Fatigue
22%
Dyspnoea
21%
Insomnia
20%
Nausea
20%
Back pain
19%
Pyrexia
18%
Bronchitis
18%
Cough
17%
Vomiting
17%
Pneumonia
16%
Neutropenia
15%
Headache
13%
Muscle spasms
12%
Oedema peripheral
11%
Neuropathy peripheral
11%
Respiratory tract infection
11%
Arthralgia
11%
Asthenia
11%
Nasopharyngitis
9%
Decreased appetite
9%
Hyperglycaemia
9%
Cataract
9%
Lymphopenia
8%
Peripheral sensory neuropathy
8%
Influenza
8%
Pain in extremity
8%
Dizziness
7%
Leukopenia
7%
Productive cough
7%
Muscular weakness
7%
Infusion related reaction
7%
Urinary tract infection
7%
Constipation
7%
Hypokalaemia
7%
Rash
6%
Hypogammaglobulinaemia
6%
Lower respiratory tract infection
6%
Pharyngitis
6%
Fall
6%
Hypocalcaemia
6%
Musculoskeletal chest pain
6%
Myalgia
6%
Pruritus
6%
Chills
5%
COVID-19 pneumonia
5%
COVID-19
5%
Sinusitis
5%
Contusion
5%
Oropharyngeal pain
5%
Conjunctivitis
5%
Oedema
4%
Tachycardia
4%
Abdominal pain
4%
Sepsis
3%
Epistaxis
3%
Acute kidney injury
3%
Plasma cell myeloma
2%
Atrial fibrillation
2%
Septic shock
2%
Pulmonary embolism
2%
Pulmonary oedema
1%
Cellulitis
1%
Pulmonary arterial hypertension
1%
Pulmonary hypertension
1%
Respiratory failure
1%
Infection
1%
Acute coronary syndrome
1%
Atrial flutter
1%
Myocardial ischaemia
1%
Sudden death
1%
Pneumonia respiratory syncytial viral
1%
Overdose
1%
Blood creatinine increased
1%
Osteonecrosis of jaw
1%
Pathological fracture
1%
Plasmacytoma
1%
Syncope
1%
Febrile neutropenia
1%
Thrombotic thrombocytopenic purpura
1%
Cardiac failure acute
1%
Cardiac failure
1%
Cardio-respiratory arrest
1%
Bacteraemia
1%
Upper gastrointestinal haemorrhage
1%
Hepatic function abnormal
1%
Lung infection
1%
Device related infection
1%
Pneumonia cytomegaloviral
1%
Respiratory syncytial virus infection
1%
Hyperkalaemia
1%
Tumour lysis syndrome
1%
Viral infection
1%
Squamous cell carcinoma
1%
Posterior reversible encephalopathy syndrome
1%
Pleural effusion
1%
Interstitial lung disease
1%
Pneumonitis
1%
Cardiac arrest
1%
Myocardial infarction
1%
Acute myocardial infarction
1%
Cerebrovascular accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
KdD - Carfilzomib, Dexamethasone and Daratumumab
Kd - Carfilzomib and Dexamethasone
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Arm: Cycle 5+ Partial Response or BetterExperimental Treatment2 Interventions
Subjects will be treated the following:
Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks
Lenalidomide 25 milligrams/kilograms daily days 1-21 out of a 28 day cycle
Group II: Experimental Arm: Cycle 1-4 All subjectsActive Control3 Interventions
Subjects will be treated with the following:
Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks
Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle
Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab
Group III: Experimental Arm: Cycle 5+ Less than Partial ResponseActive Control3 Interventions
Subjects will be treated the following:
Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks
Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle
Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
FDA approved
Lenalidomide
FDA approved
Find a site
Who is running the clinical trial?
University of RochesterLead Sponsor
815 Previous Clinical Trials
515,083 Total Patients Enrolled
11 Trials studying Multiple Myeloma
298 Patients Enrolled for Multiple Myeloma
Frank Passero, MDPrincipal Investigator - University of Rochester
Delaware County Memorial Hospital
University Of Pennsylvania School Of Medicine (Medical School)
Pa Hospital-Uphs (Residency)
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What symptoms is Daratumumab typically prescribed to alleviate?
"Daratumumab is generally prescribed as a treatment for ophthalmia, sympathetic. It can also be utilized to address branch retinal vein occlusion and macular edema in patients who have experienced at least two rounds of systemic chemotherapy."
Answered by AI
How many participants are being admitted to this clinical research?
"Affirmative. According to information on clinicaltrials.gov, this medical trial is presently seeking participants and was first published on July 27th 2021 with a subsequent update date of July 8th 2022. The research will require 28 individuals at one site for completion."
Answered by AI
Have any other investigations been conducted involving Daratumumab?
"Currently, 745 studies are in progress for Daratumumab with 169 of them classified as Phase 3. Most experiments occur in Joliet, Illinois although there are 26198 locations worldwide running trials involving this medication."
Answered by AI
Am I eligible to contribute to this research endeavor?
"This clinical research is searching for 28 individuals between 18 and 75 with multiple myeloma. In addition to this, the participants must be newly diagnosed, surgically sterile or post-menopausal (if female), not have received therapy before, and have a performance status of 3 or less in order to qualify."
Answered by AI
Is there any risk associated with Daratumumab treatments?
"While there is a limited data set to support the safety of daratumumab, no evidence exists that demonstrates efficacy. So, our team at Power rated it as a 2 on their scale from 1 to 3."
Answered by AI
Are participants over the age of sixty eligible for enrollment in this research project?
"This research is targeting individuals between 18 and 75 years of age."
Answered by AI
Is it currently feasible for volunteers to join this experiment?
"Correct. Clinicaltrials.gov information indicates that this trial is actively recruiting, with the first listing being published on July 27th 2021 and recently edited on July 8th 2022. They are searching to enroll 28 individuals from one site location."
Answered by AI