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Trial record 1 of 1 for:    MMY1005
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A Study of JNJ-54767414 (Daratumumab) in Combination With Bortezomib and Dexamethasone (D-Vd) in Japanese Participants With Relapsed or Refractory Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02497378
First Posted: July 14, 2015
Last Update Posted: October 16, 2017
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 JNJ-54767414 (daratumumab) in Combination With Bortezomib and Dexamethasone (D-Vd) in Japanese participants with relapsed (the return of a medical problem) or refractory (not responding to treatment) multiple myeloma.

Condition Intervention Phase
Multiple Myeloma Drug: JNJ-54767414 (Daratumumab) Drug: Bortezomib Drug: Dexamethasone Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study of JNJ-54767414 (Daratumumab) in Combination With Bortezomib and Dexamethasone (D-Vd) in Japanese Patients With Relapsed or Refractory Multiple Myeloma (MM)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Approximately 2 years ]
    An AE was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.


Secondary Outcome Measures:
  • Minimum Observed Serum Concentration (Cmin) of JNJ-54767414 (Daratumumab) [ Time Frame: Approximately 2 years ]
    The Cmin is the maximum observed serum concentration of JNJ-54767414.

  • Maximum Observed Serum Concentration (Cmax) of JNJ-54767414 (Daratumumab) [ Time Frame: Approximately 2 years ]
    The Cmax is the maximum observed serum concentration of JNJ-54767414.

  • Serum Concentration of JNJ-54767414 (Daratumumab) Antibodies [ Time Frame: Approximately 2 years ]
    Serum levels of antibodies to Daratumumab for evaluation of potential immunogenicity.

  • Percentage of Participants With Overall Response Rate (ORR) [ Time Frame: Approximately 2 years ]
    Overall response rate is defined as the percentage of participants who achieve complete response or partial response according to the International Myeloma Working Group criteria, during or after study treatment.

  • Percentage of Participants with Complete Response (CR) or better [ Time Frame: Approximately 2 years ]
    CR is Defined as the proportion of Participants achieving CR (including sCR) according to the IMWG criteria.

  • Percentage of Participants with a Very Good Partial Response (VGPR) or better [ Time Frame: Approximately 2 years ]
    VGPR is defined as a greater than 90% reduction in serum myeloma protein (M-protein) plus urine myeloma protein less than 100 milligram (mg) per 24 hours.

  • Time to Response [ Time Frame: Approximately 2 years ]
    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 (CR or PR).


Enrollment: 8
Actual Study Start Date: July 10, 2015
Estimated Study Completion Date: January 31, 2018
Estimated Primary Completion Date: November 6, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: JNJ-54767414 (Daratumumab) +Bortezomib+Dexamethasone
Participants will be administered JNJ-54767414 (daratumumab) intravenously at a dose of 16 milligram per kilogram (mg/kg) weekly for the first 3 cycles, then on Day 1 of Cycles 4-8 (every 3 weeks), and then on Day 1 of subsequent cycles (every 4 weeks), First 8 Cycles are 21-day cycles; Cycles 9 and onwards are 28-day cycles. Bortezomib at a dose of 1.3 milligram per meter square (mg/m^2) subcutaneously (SC) on Days 1, 4, 8 and 11 of each 21-day cycle for 8 treatment cycles and Dexamethasone orally at 20 mg on Day 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 bortezomib treatment cycles.
Drug: JNJ-54767414 (Daratumumab)
JNJ-54767414 (Daratumumab) will be administered as an Intravenous (IV) infusion at a dose of 16 milligram per kilogram (mg/kg) weekly for the first 3 cycles, on Day 1 of Cycles 4-8 (every 3 weeks), and then on Day 1 of subsequent cycles (every 4 weeks). First 8 Cycles are 21-day cycles; Cycles 9 and onwards are 28-day cycles.
Drug: Bortezomib
Bortezomib will be administered at a dose of 1.3 mg/m^2 subcutaneously (SC) on Day 1, 4, 8 and 11 of each 21-day cycle. Eight Bortezomib treatment cycles are to be administered.
Other Name: VELCADE
Drug: Dexamethasone
Dexamethasone will be administered orally at 20 mg on Day 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 bortezomib treatment cycles (except for Cycles 1-3). In Cycles 1-3, participants receive dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11, 12 and 15. During weeks when the participants receives an infusion of daratumumab, dexamethasone will be administered at a dose of 20 mg IV or orally (PO) (only if IV is not available) before the daratumumab infusion as preinfusion medication.

Detailed Description:
This is an 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 (21 days prior to Cycle 1 Day 1); open-label treatment phase (from Cycle 1 Day 1 until study treatment discontinuation, disease progression, unacceptable toxicity, or other reasons), and a Follow-up Phase. Bortezomib and Dexamethasone will be administered along with JNJ-54767414 for first 8 treatment cycles. Follow-up Phase begins immediately following the End-of-Treatment Visit, and will continue until 8 weeks after last study treatment, death, loss to follow-up, consent withdrawal for study participation, or study end, whichever occurs first. Participants' safety will be monitored throughout the study.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 (MM) according the International Myeloma Working Group (IMWG) diagnostic criteria
  • Participant must have documented MM as defined by following criteria: Monoclonal plasma cells in the bone marrow 10 percent (%), or presence of a biopsy-proven plasmacytoma at some point in their disease history, disease measurements: a) Serum M-protein greater than or equal to (>=) 1 gram per deciliter (g/dL) (>=10 gram per liter [g/L]) b) Serum immunoglobulin A [IgA] M-protein >= 0.5 g/dL); c) Urine M-protein >=200 milligram per 24 hour (mg/24 h); d) Serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
  • Participant must have received at least 1 prior line of therapy for MM
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Participant must have achieved a response (partial response [PR] or better based on investigator's determination of response by the IMWG criteria) to at least 1 prior regimen

Exclusion Criteria:

  • Participant has received daratumumab or other anti-cluster of differentiation 38 (anti-CD38) therapies previously
  • Is refractory to bortezomib or another PI, like ixazomib and carfilzomib (had progression of disease while receiving bortezomib therapy or within 60 days of ending bortezomib therapy or another PI therapy, like ixazomib and carfilzomib
  • Is intolerant to bortezomib (ie, discontinued due to any adverse event while on bortezomib treatment)
  • Has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of daratumumab first administration. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 milligram per day [mg/day] for a maximum of 4 days) before treatment. A list of anti-myeloma treatments with the corresponding pharmacokinetic half-lives is provided in the Site Investigational Product Procedures Manual (IPPM)
  • Has a history of malignancy (other than multiple myeloma) within 3 years before the date of daratumumab first administration
  • Has any concurrent medical condition or disease (eg, active systemic infection, pulmonary impairment) that is likely to interfere with study procedures
  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): NCT02497378


Locations
Japan
Hiroshima, Japan
Hitachi, Japan
Nagoya, Japan
Shibuya, Japan
Tachikawa, Japan
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
Study Director: Janssen Pharmaceutical K.K. Clinical Trial Janssen Pharmaceutical K.K.
  More Information

Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT02497378     History of Changes
Other Study ID Numbers: CR107666
54767414MMY1005 ( Other Identifier: Janssen Pharmaceutical K.K. )
First Submitted: July 10, 2015
First Posted: July 14, 2015
Last Update Posted: October 16, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Pharmaceutical K.K.:
Multiple Myeloma
Daratumumab
JNJ-54767414
Bortezomib
Dexamethasone

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
Dexamethasone acetate
Dexamethasone
Daratumumab
Bortezomib
BB 1101
Antibodies, Monoclonal
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal