A Study of Subcutaneous Delivery of JNJ-54767414 in Chinese Participants With Multiple Myeloma

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04121260
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    Participants will receive dose 1 daratumumab with 30,000 U (2000 U/mL) with rHuPH20 SC injection.

Study Details

The purpose of this study is to evaluate the safety and pharmacokinetic of Daratumumab subcutaneously in Chinese participants with relapsed or refractory Multiple Myeloma.

Key Dates

Start date
Dec 25, 2019
Status verified
Dec 2023
Primary completion
Apr 27, 2021
Completion
Oct 13, 2023

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Daratumumab
    Participants will receive daratumumab dose 1 subcutaneously (SC) with recombinant human hyaluronidase \[rHuPH20\] 30,000 units \[U\] that is 2,000 U/milliliter (U/mL) SC injection once weekly for the first 8 weeks Cycles 1 and 2 (Days 1, 8, 15, and 22 of each week), every 2 weeks Cycles 3 to 6 (Days 1 and 15) or the following 16 weeks and then every 4 weeks from Cycle 7 \[Day 1\] in subsequent cycles, until disease progression, unacceptable toxicity, or any other reason for discontinuation. Each cycle is 28 days in duration.

Primary Outcome Measure

Number of participants with Adverse Events (AEs) and Serious AEs [ Time Frame: Up to 2 years ]

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