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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

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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%

Cough

14%

Back Pain

13%

Pyrexia

13%

Neutropenia

12%

Upper Respiratory Tract Infection

12%

Nausea

12%

Diarrhoea

12%

Chills

11%

Dyspnoea

10%

Headache

10%

Fatigue

Hypertension

Constipation

Nasopharyngitis

Vomiting

Arthralgia

Asthenia

Hypokalaemia

Lymphopenia

Musculoskeletal Chest Pain

Oedema Peripheral

Nasal Congestion

Insomnia

Pneumonia

Musculoskeletal Pain

Pain in Extremity

Bone Pain

Leukopenia

Dizziness

Bronchitis

Acute Kidney Injury

Lower Respiratory Tract Infection

Sepsis

Septic Shock

General Physical Health Deterioration

Hypercalcaemia

Confusional State

Influenza

Respiratory Tract Infection

Hyperglycaemia

Inguinal Hernia

Myocardial Infarction

Femur Fracture

Urinary Tract Infection

Pneumocystis Jirovecii Pneumonia

Febrile Neutropenia

Lung Infection

100%

80%

60%

40%

20%

Study treatment Arm

Daratumumab IV

Daratumumab SC

Awards & Highlights

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.

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

0 / 6Eligibility criteria met