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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
Must not have
Received daratumumab or other anti-CD38 therapies previously
Received autologous stem cell transplant within 12 weeks before the date of randomization, or the participant has previously received allogeneic stem cell transplant (regardless of timing)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Summary

This trial tests if injecting a cancer drug and an enzyme under the skin is as effective as giving the drug through an IV for adults with multiple myeloma who haven't responded to other treatments.

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.
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.
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 below
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You have been diagnosed with multiple myeloma based on specific medical criteria.
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You are able to perform daily activities without any problems or with minimal restrictions due to your health.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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You have been treated with daratumumab or other medications targeting CD38 in the past.
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You had a stem cell transplant in the past 12 weeks, or you had a different type of stem cell transplant at any time.
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You are planning to have a stem cell transplant before your condition gets worse during the study.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Trough Concentration (Ctrough) of Daratumumab
Overall Response Rate (ORR)
Secondary study objectives
Duration of Response
Overall Survival (OS)
Patient-Reported Satisfaction With Therapy as Assessed With Cancer Therapy Satisfaction Questionnaire (CTSQ)
+8 more

Side effects data

From 2024 Phase 3 trial • 522 Patients • NCT03277105
25%
Anaemia
19%
Thrombocytopenia
14%
Back Pain
14%
Cough
13%
Pyrexia
13%
Neutropenia
12%
Upper Respiratory Tract Infection
12%
Chills
12%
Diarrhoea
12%
Nausea
11%
Dyspnoea
10%
Fatigue
10%
Headache
9%
Constipation
9%
Hypertension
8%
Vomiting
8%
Nasopharyngitis
7%
Arthralgia
7%
Asthenia
7%
Hypokalaemia
7%
Lymphopenia
6%
Oedema Peripheral
6%
Musculoskeletal Chest Pain
5%
Pneumonia
5%
Insomnia
5%
Nasal Congestion
5%
Musculoskeletal Pain
5%
Pain in Extremity
4%
Bone Pain
4%
Leukopenia
4%
Dizziness
3%
Bronchitis
2%
General Physical Health Deterioration
2%
Lower Respiratory Tract Infection
2%
Sepsis
2%
Acute Kidney Injury
2%
Septic Shock
2%
Hypercalcaemia
1%
Influenza
1%
Confusional State
1%
Hyperglycaemia
1%
Inguinal Hernia
1%
Pneumocystis Jirovecii Pneumonia
1%
Urinary Tract Infection
1%
Myocardial Infarction
1%
Respiratory Tract Infection
1%
Femur Fracture
1%
Febrile Neutropenia
1%
Lung Infection
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
987 Previous Clinical Trials
6,385,137 Total Patients Enrolled
75 Trials studying Multiple Myeloma
19,294 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
753 Previous Clinical Trials
3,960,937 Total Patients Enrolled
52 Trials studying Multiple Myeloma
14,275 Patients Enrolled for Multiple Myeloma

Media Library

Daratumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03277105 — Phase 3
Multiple Myeloma Research Study Groups: Dara SC, Dara IV
Multiple Myeloma Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT03277105 — Phase 3
Daratumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03277105 — Phase 3
~67 spots leftby Sep 2025
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