A Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT)

October 31, 2013 updated by: Janssen Pharmaceutical K.K.

A Phase I/II Clinical Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT)

The purpose of the study in Phase I is to select the recommended dose of bortezomib in combination with melphalan and prednisolone in Japanese participants. In Phase II, to assess the effectiveness and safety of the recommended dose of bortezomib (selected in the phase I portion).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label (both physician and participant know the intervention), non-randomized (participants are not assigned by chance), multi-center study in untreated multiple myeloma participants who were not candidates for hematopoietic stem cell transplant. This study consists of two parts: Phase I and Phase II. In Phase I, a total of 18 participants will be enrolled ie, 6 patients per dose level (0.7, 1.0 and 1.3 mg/m2) to determine the recommended dose of bortezomib. In Phase II, additional 83 participants will be enrolled. Safety evaluations will include assessment of adverse events, clinical laboratory test, specifically hematological toxicities.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan
      • Hiroshima N/A, Japan
      • Hitachi, Japan
      • Isehara, Japan
      • Kamogawa, Japan
      • Kanazawa, Japan
      • Kawagoe, Japan
      • Kobe, Japan
      • Koto-Ku, Japan
      • Kumamoto, Japan
      • Kurashiki, Japan
      • Kurume, Japan
      • Kyoto, Japan
      • Nagasaki, Japan
      • Nagoya, Japan
      • Narita, Japan
      • Niigata, Japan
      • Okayama, Japan
      • Osaka-Sayama, Japan
      • Sapporo, Japan
      • Shibukawa, Japan
      • Suita, Japan
      • Tokushima N/A, Japan
      • Tokyo, Japan
      • Toyama-City, Japan
      • Toyohashi, Japan
      • Utsunomiya, Japan
      • Yokohama, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants diagnosed with symptomatic or nonsecretory multiple myeloma
  • Participants who have not received chemotherapy and are not hematopoietic stem cell transplantation candidates
  • Participants with a measurable lesion
  • Life expectancy greater than or equal to 3 months

Exclusion Criteria:

  • Previously received treatment for Multiple Myeloma
  • Greater than or equal to Grade 2 peripheral neuropathy or neuropathic pain
  • Myocardial infarction within 6 months prior to enrollment or uncontrolled angina, severe uncontrolled ventricular arrhythmias, or clinically significant conduction system abnormalities
  • Patient is known to be seropositive for the human immunodeficiency virus (HIV), Hepatitis B surface antigen-positive or active hepatitis C infection
  • Active prior malignancy diagnosed within the last 5 years
  • Female participant who is pregnant or breast-feeding
  • Participant is enrolled in another clinical research study and/or is receiving an investigational agent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase I: JNJ-26866138 0.7 mg/m2
JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles.
Drug: JNJ-26866138 0.7 mg/m2
JNJ-26866138 0.7 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles.
Other Names:
  • bortezomib
Drug: Melphalan
Melphalan 9 mg/m2 will be taken orally (by mouth) on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
Drug: Prednisolone
Prednisolone 60 mg/m2 will be taken orally (by mouth) on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
Experimental: Phase I: JNJ-26866138 1.0 mg/m2
JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
Drug: Melphalan
Melphalan 9 mg/m2 will be taken orally (by mouth) on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
Drug: Prednisolone
Prednisolone 60 mg/m2 will be taken orally (by mouth) on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
Drug: JNJ-26866138 1.0 mg/m2
JNJ-26866138 1.0 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles
Other Names:
  • bortezomib
Experimental: Phase I: JNJ-26866138 1.3 mg/m2
JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
Drug: Melphalan
Melphalan 9 mg/m2 will be taken orally (by mouth) on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
Drug: Prednisolone
Prednisolone 60 mg/m2 will be taken orally (by mouth) on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
Drug: JNJ-26866138 1.3 mg/m2
Phase I: JNJ-26866138 1.3 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Phase II: JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5 to 9 cycles.
Other Names:
  • bortezomib
Experimental: Phase II: JNJ-26866138 1.3 mg/m2
JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
Drug: Melphalan
Melphalan 9 mg/m2 will be taken orally (by mouth) on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
Drug: Prednisolone
Prednisolone 60 mg/m2 will be taken orally (by mouth) on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
Drug: JNJ-26866138 1.3 mg/m2
Phase I: JNJ-26866138 1.3 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Phase II: JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5 to 9 cycles.
Other Names:
  • bortezomib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Dose Limiting Toxicity During the Phase I (Cycle 1)
Time Frame: 6 weeks
Dose limiting toxicity defined as an adverse event or adverse drug reaction experienced by the participants during 6 weeks of treatment Cycle 1
6 weeks
Number of Participants With Overall Response (Complete Response [CR] + Partial Response [PR]) - Phase I and II
Time Frame: 54 weeks
Response is evaluated as per the criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation (Blade et al. 1998). CR: disappearance of the original monoclonal protein from the blood and urine and <5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks; no increase in the size or number of lytic bone lesions; disappearance of soft tissue plasmacytomas for at least 6 weeks. PR: ≥50% reduction in the level of serum monoclonal protein for at least 2 determinations 6 weeks apart; If present, reduction in 24-hour urinary light chain excretion by either ≥90% or to <200 mg for at least 2 determinations 6 weeks apart; ≥50% reduction in the size of soft tissue plasmacytomas for at least 6 weeks; no increase in size or number of lytic bone lesions
54 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 Alone) - Phase I
Time Frame: Day 25 of Cycle 1
Cmax of bortezomib following intravenous administration of JNJ-26866138 at dose of 0.7, 1.0, and 1.3 mg/m2 on Cycle 1/Day 25 (JNJ-26866138 alone)
Day 25 of Cycle 1
Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 in Combination With Melphalan and Prednisolone) - Phase I
Time Frame: Day 4 of Cycle 2
Cmax of bortezomib following intravenous administration of JNJ-26866138 at dose of 0.7, 1.0, and 1.3 mg/m2 on Cycle 2/Day 4 (combination with melphalan and prednisolone)
Day 4 of Cycle 2
Maximum Observed Plasma Concentration (Cmax) of Melphalan - Phase I
Time Frame: Day 4 of Cycle 2
Cmax of melphalan at dose of 9 mg/m2 on Cycle 2/Day 4
Day 4 of Cycle 2
Maximum Observed Plasma Concentration (Cmax) of Prednisolone - Phase I
Time Frame: Day 4 of Cycle 2
Cmax of Prednisolone at dose of 60 mg/m2 on Cycle 2/Day 4
Day 4 of Cycle 2
Median Time to First Response - Phase II
Time Frame: up to 54 weeks
Time to first response is the duartion of time required to achieve first response to treatment
up to 54 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Pharmaceutical K.K.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

September 18, 2009

First Submitted That Met QC Criteria

September 25, 2009

First Posted (Estimate)

September 29, 2009

Study Record Updates

Last Update Posted (Estimate)

December 2, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR014776
  • JNJ-26866138-JPN-MM-102 (Other Identifier: Janssen Pharmaceutical K.K., Japan)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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