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Monoclonal Antibodies

Daratumumab for Multiple Myeloma

Phase 3
Recruiting
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
A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 3 months after receiving the last dose of study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years 7 months
Awards & highlights

Study Summary

This trial will provide daratumumab to participants with multiple myeloma who are still benefitting from the treatment, in order to collect long-term safety data.

Who is the study for?
This trial is for individuals with multiple myeloma or smoldering multiple myeloma who are benefiting from ongoing Janssen R&D studies involving daratumumab. Participants must not be pregnant, agree to contraception, have signed an informed consent form, and adhere to lifestyle restrictions. They should continue to benefit from the treatment without disease progression or unmanageable toxicity.Check my eligibility
What is being tested?
The study provides access to treatments like Daratumumab (alone or with other drugs) for participants in previous trials where it showed benefits. It aims to allow continued use of these treatments and collect long-term safety data on their effectiveness against multiple myeloma.See study design
What are the potential side effects?
Potential side effects may include those associated with Daratumumab and its combination therapies such as immune reactions, infusion-related responses, blood disorders, fatigue, digestive issues, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I agree not to donate sperm during and for 3 months after the study.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with AEs of Special Interest (AESI)
Number of Participants with Abnormal Pregnancies as SAE
Number of Participants with Pregnancies or Partner Pregnancies
+1 more

Side effects data

From 2024 Phase 3 trial • 498 Patients • NCT02136134
60%
Thrombocytopenia
50%
Peripheral sensory neuropathy
47%
Peripheral Sensory Neuropathy
36%
Upper respiratory tract infection
36%
Diarrhoea
29%
Cough
28%
Anaemia
23%
Fatigue
23%
Upper Respiratory Tract Infection
23%
Constipation
21%
Back pain
20%
Arthralgia
20%
Oedema peripheral
19%
Neutropenia
19%
Dyspnoea
18%
Insomnia
17%
Pyrexia
16%
Oedema Peripheral
15%
Nausea
14%
Lymphopenia
14%
Pain in extremity
14%
Nasopharyngitis
14%
Bronchitis
14%
Neuralgia
13%
Back Pain
13%
Dizziness
12%
Decreased appetite
12%
Vomiting
12%
Headache
12%
Hypertension
11%
Conjunctivitis
11%
Asthenia
11%
Pneumonia
11%
Hypokalaemia
10%
Muscle spasms
10%
Musculoskeletal chest pain
9%
Urinary tract infection
9%
Leukopenia
9%
Bone pain
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Weight decreased
8%
Muscle Spasms
8%
Abdominal pain upper
8%
Alanine aminotransferase increased
7%
Hypophosphataemia
7%
Herpes zoster
7%
Influenza
7%
Hypocalcaemia
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Aspartate aminotransferase increased
6%
Nasal congestion
6%
Abdominal pain
5%
Bone Pain
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Chills
5%
Productive cough
5%
Throat irritation
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Atrial fibrillation
2%
Acute kidney injury
2%
Sepsis
2%
Atrial Fibrillation
1%
Acute myocardial infarction
1%
Pneumonia cytomegaloviral
1%
Pleural effusion
1%
Rib fracture
1%
Lower Respiratory Tract Infection
1%
Pulmonary sepsis
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Acute coronary syndrome
1%
Lower respiratory tract infection
1%
Hip fracture
1%
Angina unstable
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Bronchitis chronic
1%
Humerus fracture
1%
Respiratory failure
1%
Gastroenteritis
1%
Pathological fracture
1%
Femur fracture
1%
Febrile neutropenia
1%
Squamous cell carcinoma of skin
1%
Ischaemic Stroke
1%
Respiratory Failure
1%
Pathological Fracture
1%
Febrile Neutropenia
1%
Cardiac Failure Congestive
1%
Bronchopneumonia
1%
Femur Fracture
1%
Humerus Fracture
1%
Acute Kidney Injury
1%
Pleural Effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daratumumab + Bortezomib and Dexamethasone (DVd)
Bortezomib + Dexamethasone (Vd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: DaratumumabExperimental Treatment5 Interventions
Participants will receive a single dose of daratumumab 16 milligrams per kilograms (mg/kg) intravenous (IV) or 1800 mg subcutaneous (SC) infusion on Cycle 1 Day 1 (28-day cycle), as monotherapy or in combination with standards of care treatment (that is, pomalidomide and dexamethasone, lenalidomide and dexamethasone, carfilzomib and dexamethasone) or standards of care treatment alone, depending on the treatment received in the parent study. Participants who received daratumumab IV during the parent study, will have an option to switch to daratumumab SC on Day 1 of any cycle during this long-term extension study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1480
Pomalidomide
2011
Completed Phase 2
~1020
Daratumumab
2014
Completed Phase 3
~1990
Carfilzomib
2017
Completed Phase 3
~1440
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
976 Previous Clinical Trials
6,384,192 Total Patients Enrolled
70 Trials studying Multiple Myeloma
18,962 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
746 Previous Clinical Trials
3,959,778 Total Patients Enrolled
49 Trials studying Multiple Myeloma
13,929 Patients Enrolled for Multiple Myeloma

Media Library

Daratumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05438043 — Phase 3
Multiple Myeloma Research Study Groups: Daratumumab
Multiple Myeloma Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT05438043 — Phase 3
Daratumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05438043 — Phase 3

Frequently Asked Questions

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

Are there any open vacancies for this clinical trial?

"No, this particular study is not recruiting patients at the moment. However, it was last edited on November 3rd, 2022 and was initially posted just over a month ago on December 23rd. There are 824 other trials that are currently accepting patients."

Answered by AI

Has Daratumumab been given the okay by the FDA?

"There is a fair amount of clinical data supporting Daratumumab's safety, thus it was given a score of 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Daratumumab
2022. "A Study of Daratumumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05438043.
~284 spots leftby Jan 2026
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