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A Study of Subcutaneous Delivery of JNJ-54767414 (Daratumumab) in Japanese Participants With Relapsed or Refractory Multiple Myeloma

NCT03242889 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-04-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate the tolerability and safety of subcutaneous (SC) delivery of co-formulated daratumumab and rHuPH20 preparation (DARA SC) in Japanese participants with relapsed or refractory multiple myeloma (MM).

Conditions

Interventions

DRUG

DARA SC

Participants will receive 1800 mg daratumumab with 30,000 U (2000 U/mL) rHuPH20 SC injection once weekly for the first 8 weeks in Cycles 1 and 2 and every 2 weeks in Cycles 3 to 6 for 16 weeks and then every 4 weeks in subsequent cycles until disease progression, unacceptable toxicity, or any other reason for discontinuation.

Sponsors & Collaborators

  • Janssen Pharmaceutical K.K.

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutical K.K., Japan Clinical Trial · Janssen Pharmaceutical K.K.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-10
Primary Completion
2017-11-01
Completion
2023-02-10

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03242889 on ClinicalTrials.gov