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Monoclonal Antibodies
Daratumumab Administration Methods for Multiple Myeloma
Phase 3
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
Documented multiple myeloma as defined by the IMWG diagnostic criteria
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing whether a new way of administering daratumumab (under the skin instead of through a vein) is just as effective as the current method.
Who is the study for?
This trial is for adults with multiple myeloma who've had at least three prior treatments, including a proteasome inhibitor and an immunomodulatory drug, unless they had severe allergies to these. They must show some response to previous treatments and have measurable disease. Women of childbearing age need a negative pregnancy test. People can't join if they've had certain other cancers or stem cell transplants, or if they plan one soon.Check my eligibility
What is being tested?
The study compares two ways of giving daratumumab: directly into the bloodstream (IV) versus under the skin (SC). It's checking whether SC is just as good as IV in terms of how well it works against cancer and how much stays in the blood over time.See study design
What are the potential side effects?
Daratumumab may cause side effects like allergic reactions during infusion, fatigue, nausea, diarrhea, low blood counts increasing infection risk, nerve damage symptoms like tingling or numbness, and possibly others depending on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have been diagnosed with multiple myeloma based on specific medical criteria.
Select...
You are able to perform daily activities without any problems or with minimal restrictions due to your health.
Select...
You have shown improvement, like a partial response or better, to at least one previous treatment according to the doctor's evaluation using specific criteria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Trough Concentration (Ctrough) of Daratumumab
Overall Response Rate (ORR)
Secondary outcome measures
Duration of Response
Overall Survival (OS)
Patient-Reported Satisfaction With Therapy as Assessed With Cancer Therapy Satisfaction Questionnaire (CTSQ)
+8 moreSide effects data
From 2024 Phase 3 trial • 522 Patients • NCT0327710525%
Anaemia
19%
Thrombocytopenia
14%
Back Pain
14%
Cough
13%
Pyrexia
13%
Neutropenia
12%
Upper Respiratory Tract Infection
12%
Diarrhoea
12%
Nausea
12%
Chills
11%
Dyspnoea
10%
Fatigue
10%
Headache
9%
Constipation
9%
Hypertension
8%
Nasopharyngitis
8%
Vomiting
7%
Hypokalaemia
7%
Asthenia
7%
Arthralgia
7%
Lymphopenia
6%
Musculoskeletal Chest Pain
6%
Oedema Peripheral
5%
Pneumonia
5%
Musculoskeletal Pain
5%
Pain in Extremity
5%
Insomnia
5%
Nasal Congestion
4%
Dizziness
4%
Bone Pain
4%
Leukopenia
3%
Bronchitis
2%
Acute Kidney Injury
2%
Sepsis
2%
Septic Shock
2%
Lower Respiratory Tract Infection
2%
General Physical Health Deterioration
2%
Hypercalcaemia
1%
Pneumocystis Jirovecii Pneumonia
1%
Inguinal Hernia
1%
Febrile Neutropenia
1%
Lung Infection
1%
Femur Fracture
1%
Respiratory Tract Infection
1%
Urinary Tract Infection
1%
Confusional State
1%
Influenza
1%
Myocardial Infarction
1%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daratumumab IV
Daratumumab SC
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Dara SCExperimental Treatment1 Intervention
Participants will receive a fixed dose of daratumumab as 1800 milligram (mg) subcutaneously (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Unit per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks.
Group II: Dara IVActive Control2 Interventions
Participants will receive daratumumab for intravenous infusion (Dara IV) 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks on Day 1 in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The duration for each cycle is 4 weeks. For Participants still receiving treatment with Dara-IV at the time of Protocol Amendment 4 the duration of infusion may be shortened to a 90-minute infusion or participants will have the option to switch to Dara 1800 mg subcutaneous (SC) on Day 1 of any cycle, at the discretion of the investigator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dara SC
2017
Completed Phase 3
~530
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,786 Total Patients Enrolled
70 Trials studying Multiple Myeloma
18,895 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,383 Total Patients Enrolled
49 Trials studying Multiple Myeloma
13,862 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are planning to have a stem cell transplant before your condition gets worse during the study.You have received at least three different types of treatment, including specific medications called proteasome inhibitors and immunomodulatory drugs, unless you had a severe allergic reaction to them early in your treatment.You have been treated with daratumumab or other medications targeting CD38 in the past.You are able to perform daily activities without any problems or with minimal restrictions due to your health.You had a stem cell transplant in the past 12 weeks, or you had a different type of stem cell transplant at any time.You have a specific level of abnormal proteins in your blood or urine that can be measured.You had cancer (except for multiple myeloma) and finished treatment at least 2 years ago with no signs of the disease. Some types of non-invasive cancers may be allowed if considered cured with low risk of coming back within 3 years.You have shown improvement, like a partial response or better, to at least one previous treatment according to the doctor's evaluation using specific criteria.Women who could become pregnant must have a negative pregnancy test within 14 days before starting the study.You have been diagnosed with multiple myeloma based on specific medical criteria.You need to meet specific medical test requirements outlined in the study plan.You have taken medication for myeloma within 2 weeks or 5 pharmacokinetic half-lives before the trial starts.
Research Study Groups:
This trial has the following groups:- Group 1: Dara SC
- Group 2: Dara IV
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
For what purpose is Dara SC most often employed?
"Dara SC can help patients with various conditions, such as refractory multiple myeloma or relapsed cell transplants. Additionally, it is also useful for treating biological response modifiers."
Answered by AI
Are there any other ongoing studies that use Dara SC as a treatment?
"Currently, there are 142 Dara SC clinical trials ongoing with 26 in Phase 3. Most of these studies originate from Harrison, New york; however, 5 580 locations worldwide are running Dara SC trials."
Answered by AI
Does Dara SC have any life-threatening side effects?
"Dara SC's safety is rated as a 3 by our team because it has reached Phase 3 in clinical trials. This suggests there is both efficacy and safety data from multiple rounds of testing."
Answered by AI
What is the cap on how many people can join this research project?
"Though this trial was posted on October 27th, 2017 and updated November 3rd, 2022, it is not presently recruiting patients. For those interested in other studies, there are currently 826 clinical trials actively searching for patients with multiple myeloma and 142 trials for Dara SC looking for participants."
Answered by AI
How many distinct places are in charge of this clinical trial?
"So far, this clinical trial is being conducted out of Cross Cancer Institute in Edmonton, Alberta, The Gordon & Leslie Diamond Health Care Center in Vancouver, British Columbia, and Dana-Farber Cancer Institute in Boston, Massachusetts with 9 other locations still to be determined."
Answered by AI
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