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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1, 2 and 3: Number of Participants with Adverse Events (AEs) and Serious AEs

Serum Trough Concentrations (Ctrough) of Daratumumab

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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