A Study of Daratumumab in Japanese Participants With Relapsed or Refractory Multiple Myeloma

NCT ID: NCT02116569

Last Updated: 2016-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-09-30

Brief Summary

The purpose of this study is to evaluate the tolerability and safety of Daratumumab in Japanese participants with relapsed (the return of a medical problem) or refractory (not responding to treatment) multiple myeloma (cancer of plasma cells in bone marrow, characterized by the presence of abnormal proteins in the blood).

Detailed Description

This is a Phase 1, open-label (all participants and study personnel will know the identity of the study treatments) and multicenter (study conducted at multiple sites) study in Japanese participants. The study will include a Screening Phase, a Treatment Phase, and a Follow-up Phase. The Treatment Phase consists of 2 parts: intense dosing regimen and less intense dosing regimen. Follow-up phase will be until 8 weeks after last dose administration/death/lost to follow up/consent withdrawal for study participation or study end, whichever occurs first. The primary endpoints will be Dose Limiting Toxicity (DLTs) and overall Adverse Events (AEs) profiling. Participants' safety will be monitored throughout the study.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Daratumumab 8 milligram per kilogram (mg/kg)

Participants will be administered intravenously with daratumumab at a dose of 8 mg/kg up to 8 weeks (total 7 infusions). After 8 weeks, participants will receive daratumumab intravenously two times in every 2 weeks until Week 24 followed by one time in 4 weeks until study discontinuation.

Group Type: EXPERIMENTAL

Daratumumab

Intervention Type: DRUG

Participants will be administered intravenously with daratumumab at a dose of 8 or 16 mg/kg up to 8 weeks (total 7 infusions). After 8 weeks, participants will receive daratumumab intravenously at a same dose, two times in every 2 weeks until Week 24 followed by one time in 4 weeks until study discontinuation. If the dose exceeds 24 mg/kg, then it will be considered as overdose in this study.

Daratumumab 16 mg/kg

Participants will be administered intravenously with daratumumab at a dose of 16 mg/kg up to 8 weeks (total 7 infusions). After 8 weeks, participants will receive daratumumab intravenously at a same dose, two times in every 2 weeks until Week 24 followed by one time in 4 weeks until study discontinuation.

Group Type: EXPERIMENTAL

Daratumumab

Intervention Type: DRUG

Participants will be administered intravenously with daratumumab at a dose of 8 or 16 mg/kg up to 8 weeks (total 7 infusions). After 8 weeks, participants will receive daratumumab intravenously at a same dose, two times in every 2 weeks until Week 24 followed by one time in 4 weeks until study discontinuation. If the dose exceeds 24 mg/kg, then it will be considered as overdose in this study.

Interventions

Daratumumab

Participants will be administered intravenously with daratumumab at a dose of 8 or 16 mg/kg up to 8 weeks (total 7 infusions). After 8 weeks, participants will receive daratumumab intravenously at a same dose, two times in every 2 weeks until Week 24 followed by one time in 4 weeks until study discontinuation. If the dose exceeds 24 mg/kg, then it will be considered as overdose in this study.

Intervention Type: DRUG

Other Intervention Names

JNJ-54767414

Eligibility Criteria

Inclusion Criteria

• Participants proven to have symptomatic (having symptoms) multiple myeloma according the International Myeloma Working Group (IMWG) diagnostic criteria
• Participant must have measurable disease defined by either or both the following measurements: a) Serum M-protein greater than or equal to (>=) 1 gram per deciliter (g/dL) (>=10 gram per liter [g/L]) (except for serum immunoglobulin A [IgA] M-protein >= 0.5 g/dL); b) Urine M-protein >=200 milligram per 24 hour (mg/24 h); in case immunoglobulin D [IgD] or immunoglobulin E [IgE] M-protein, quantification should be performed
• Participant must have relapsed or refractory multiple myeloma after receiving at least 2 previous therapies, and without further established treatment options
• Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
• Participant must have life expectancy greater than (>) 3 months

Exclusion Criteria

• Participant has received daratumumab or other anti-cluster of differentiation 38 (anti-CD38) therapies previously
• Participant has received anti-myeloma treatment within 2 weeks before administration of the study drug
• Participant has previously received an allogenic stem cell transplant; or participant has received autologous stem cell transplantation (ASCT) within 12 weeks before administration of the study drug
• Participant has a history of malignancy (other than multiple myeloma) within 5 years before administration of the study drug
• Participant is exhibiting clinical signs of meningeal involvement of multiple myeloma

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

Nagoya, , Japan

Tokyo, , Japan

Countries

Japan

References

Li X, Dosne AG, Perez Ruixo C, Perez Ruixo JJ. Pharmacodynamic-Mediated Drug Disposition (PDMDD) Model of Daratumumab Monotherapy in Patients with Multiple Myeloma. Clin Pharmacokinet. 2023 May;62(5):761-777. doi: 10.1007/s40262-023-01232-8. Epub 2023 Apr 6.

Reference Type: DERIVED

PMID: 37022569 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&studyid=6838&filename=54767414MMY1002_Synopsis.pdf

A Phase 1 Study of JNJ-54767414 (Daratumumab) in Japanese Patients With Relapsed or Refractory Multiple Myeloma

Other Identifiers

54767414MMY1002

Identifier Type: OTHER

Identifier Source: secondary_id

CR104072

Identifier Type: -

Identifier Source: org_study_id