Trials / Completed
CompletedNCT03242889
A Study of Subcutaneous Delivery of JNJ-54767414 (Daratumumab) in Japanese Participants With Relapsed or Refractory Multiple Myeloma
A Phase 1 Study of Subcutaneous Delivery of JNJ-54767414 (Daratumumab) in Japanese Participants With Relapsed or Refractory Multiple Myeloma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Janssen Pharmaceutical K.K. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-08-10
- Primary completion
- 2017-11-01
- Completion
- 2023-02-10
- First posted
- 2017-08-08
- Last updated
- 2023-04-14
Locations
5 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03242889. Inclusion in this directory is not an endorsement.