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Monoclonal Antibodies

Daratumumab Subcutaneous (SC) Administration for Multiple Myeloma

Phase 1
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 years
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of two ways to give a drug to people with Multiple Myeloma who have not responded to other treatments.

Eligible Conditions
  • Multiple Myeloma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1, 2 and 3: Number of Participants with Adverse Events (AEs) and Serious AEs
Serum Trough Concentrations (Ctrough) of Daratumumab
Secondary outcome measures
Part 1, 2 and 3: Duration of Response (DR)
Part 1, 2 and 3: Percentage of Participants With Overall Response Rate (ORR)
Part 1, 2 and 3: Percentage of Participants with Complete Response (CR)
+2 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part 3: Dara-CF 1800 mgExperimental Treatment2 Interventions
Participants will receive co-formulated daratumumab 1800 mg and rHuPH20 preparation (Dara-CF) initially administered by SC injection once weekly in Cycles 1 and 2, every 2 weeks in Cycles 3-6, and then every 4 weeks in subsequent cycles.
Group II: Part 2: Cohort 4Experimental Treatment2 Interventions
Participants will receive 1800 mg co-formulated daratumumab and rHuPH20 preparation initially administered by SC injection once weekly in Cycles 1 and 2, every 2 weeks in Cycles 3-6, and then every 4 weeks in subsequent cycles. The dose level and schedule for any additional cohorts would be selected based on the daratumumab pharmacokinetic profile and safety profile (reviewed by the SET) that will be observed in Cohort 4.
Group III: Part 1: Cohort 3Experimental Treatment2 Interventions
Participants will receive mixture of daratumumab and rHuPH20 prepared immediately before administration via Subcutaneous (SC) delivery at a dose which will be decided by Study Evaluation Team (SET) once weekly by SC infusion in Cycles 1 and 2, every 2 weeks in Cycles 3-6, and then every 4 weeks in subsequent cycles until disease progression. Also up to three additional optional cohorts (Cohorts 3b, 3c, and 3d) may be enrolled to repeat a dose level of daratumumab.
Group IV: Part 1: Cohort 2Experimental Treatment2 Interventions
Participants will receive 1800 mg (daratumumab 1800 milligram (mg) with Recombinant Human Hyaluronidase [rHuPH20] 45,000 U) via mixing immediately before SC infusion once weekly in Cycles 1 and 2, every 2 weeks in Cycles 3-6, and then every 4 weeks in subsequent cycles until disease progression.
Group V: Part 1: Cohort 1Experimental Treatment2 Interventions
Participants will receive 1200 mg (daratumumab 1200 milligram (mg) with Recombinant Human Hyaluronidase [rHuPH20] 30,000 U) via mixing immediately before Subcutaneous (SC) infusion once weekly in Cycles 1 (each cycle is 28 days) and 2, every 2 weeks in Cycles 3-6, and then every 4 weeks in subsequent cycles until disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab Subcutaneous (SC) Administration
2015
Completed Phase 1
~120
Recombinant Human Hyaluronidase [rHuPH20]) SC Administration
2015
Completed Phase 1
~120

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,188 Total Patients Enrolled
70 Trials studying Multiple Myeloma
19,297 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,785 Total Patients Enrolled
49 Trials studying Multiple Myeloma
14,264 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
BloodJournal
Subcutaneous Delivery of Daratumumab in Relapsed or Refractory Multiple Myeloma
Usmani, Saad Z., Hareth Nahi, Maria-Victoria Mateos, Niels W. C. J. van de Donk, Ajai Chari, Jonathan L. Kaufman, Philippe Moreau, et al.. 2019. “Subcutaneous Delivery of Daratumumab in Relapsed or Refractory Multiple Myeloma”. Blood. American Society of Hematology. doi:10.1182/blood.2019000667.
clinicaltrials.govStudy
A Study of Daratumumab With the Addition of Recombinant Human Hyaluronidase (rHuPH20) for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma
2015. "A Study of Daratumumab With the Addition of Recombinant Human Hyaluronidase (rHuPH20) for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02519452.
~13 spots leftby Apr 2025
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