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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02116569
First Posted: April 17, 2014
Last Update Posted: September 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
  Purpose
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).

Condition Intervention Phase
Multiple Myeloma Drug: Daratumumab Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of JNJ-54761414 (Daratumumab) in Japanese Patients With Relapsed or Refractory Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • Number of Participants With Dose Limiting Toxicities (DLT) [ Time Frame: Day 1 up to Day 36 ]
    The Dose-Limiting Toxicities (DLTs) are based on drug-related adverse events and defined as any of the following events: Infusion-related reactions, non-hematologic toxicity of Grade 3 or higher, or hematologic toxicity.

  • Number of Participants affected by Adverse Events [ Time Frame: Baseline up to 4 Weeks after the last dose of study drug administration ]
    An AE is any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.


Secondary Outcome Measures:
  • Percentage of Participants With Overall Response [ Time Frame: Baseline until disease progression, unmanageable adverse event or death, whichever occurs first, up to 1 year ]
    The Overall Response rate is defined according to Internal Myeloma Working Group criteria based on participants achieving greater than or equal to (>=) partial Response, including participants achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR). Percentage of participants with overall response will be reported.

  • Time to Response [ Time Frame: Baseline until first documented response or up to 1 year ]
    Time to response is defined as the time from the date of first dose of study treatment to the date of the first documentation of observed response.


Enrollment: 9
Study Start Date: April 2014
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.
Other Name: JNJ-54767414
Experimental: 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.
Drug: 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.
Other Name: JNJ-54767414

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02116569


Locations
Japan
Nagoya, Japan
Tokyo, Japan
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.
  More Information

Additional Information:
Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT02116569     History of Changes
Other Study ID Numbers: CR104072
54767414MMY1002 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Submitted: April 15, 2014
First Posted: April 17, 2014
Last Update Posted: September 26, 2016
Last Verified: September 2016

Keywords provided by Janssen Pharmaceutical K.K.:
Multiple Myeloma
Daratumumab
JNJ-54767414
Phase 1
Relapse
Refractory

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Daratumumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs