search
Back to results

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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
JNJ-26866138 0.7 mg/m2
JNJ-26866138 1.0 mg/m2
JNJ-26866138 1.3 mg/m2
Melphalan
Prednisolone
Sponsored by
Janssen Pharmaceutical K.K.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple myeloma, Hematopoietic stem cell transplant, HSCT, Melphalan, Prednisolone, Bortezomib, JNJ-26866138

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Phase I: JNJ-26866138 0.7 mg/m2

Phase I: JNJ-26866138 1.0 mg/m2

Phase I: JNJ-26866138 1.3 mg/m2

Phase II: JNJ-26866138 1.3 mg/m2

Arm Description

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.

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

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

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

Outcomes

Primary Outcome Measures

Number of Participants With Dose Limiting Toxicity During the Phase I (Cycle 1)
Dose limiting toxicity defined as an adverse event or adverse drug reaction experienced by the participants during 6 weeks of treatment Cycle 1
Number of Participants With Overall Response (Complete Response [CR] + Partial Response [PR]) - Phase I and II
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

Secondary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 Alone) - Phase I
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)
Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 in Combination With Melphalan and Prednisolone) - Phase I
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)
Maximum Observed Plasma Concentration (Cmax) of Melphalan - Phase I
Cmax of melphalan at dose of 9 mg/m2 on Cycle 2/Day 4
Maximum Observed Plasma Concentration (Cmax) of Prednisolone - Phase I
Cmax of Prednisolone at dose of 60 mg/m2 on Cycle 2/Day 4
Median Time to First Response - Phase II
Time to first response is the duartion of time required to achieve first response to treatment

Full Information

First Posted
September 18, 2009
Last Updated
October 31, 2013
Sponsor
Janssen Pharmaceutical K.K.
search

1. Study Identification

Unique Protocol Identification Number
NCT00985959
Brief Title
A Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutical K.K.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple myeloma, Hematopoietic stem cell transplant, HSCT, Melphalan, Prednisolone, Bortezomib, JNJ-26866138

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase I: JNJ-26866138 0.7 mg/m2
Arm Type
Experimental
Arm Description
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.
Arm Title
Phase I: JNJ-26866138 1.0 mg/m2
Arm Type
Experimental
Arm Description
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
Arm Title
Phase I: JNJ-26866138 1.3 mg/m2
Arm Type
Experimental
Arm Description
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
Arm Title
Phase II: JNJ-26866138 1.3 mg/m2
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
JNJ-26866138 0.7 mg/m2
Other Intervention Name(s)
bortezomib
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
JNJ-26866138 1.0 mg/m2
Other Intervention Name(s)
bortezomib
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
JNJ-26866138 1.3 mg/m2
Other Intervention Name(s)
bortezomib
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Melphalan
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Participants With Dose Limiting Toxicity During the Phase I (Cycle 1)
Description
Dose limiting toxicity defined as an adverse event or adverse drug reaction experienced by the participants during 6 weeks of treatment Cycle 1
Time Frame
6 weeks
Title
Number of Participants With Overall Response (Complete Response [CR] + Partial Response [PR]) - Phase I and II
Description
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
Time Frame
54 weeks
Secondary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 Alone) - Phase I
Description
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)
Time Frame
Day 25 of Cycle 1
Title
Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 in Combination With Melphalan and Prednisolone) - Phase I
Description
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)
Time Frame
Day 4 of Cycle 2
Title
Maximum Observed Plasma Concentration (Cmax) of Melphalan - Phase I
Description
Cmax of melphalan at dose of 9 mg/m2 on Cycle 2/Day 4
Time Frame
Day 4 of Cycle 2
Title
Maximum Observed Plasma Concentration (Cmax) of Prednisolone - Phase I
Description
Cmax of Prednisolone at dose of 60 mg/m2 on Cycle 2/Day 4
Time Frame
Day 4 of Cycle 2
Title
Median Time to First Response - Phase II
Description
Time to first response is the duartion of time required to achieve first response to treatment
Time Frame
up to 54 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K., Japan Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
Facility Information:
City
Fukuoka
Country
Japan
City
Hiroshima N/A
Country
Japan
City
Hitachi
Country
Japan
City
Isehara
Country
Japan
City
Kamogawa
Country
Japan
City
Kanazawa
Country
Japan
City
Kawagoe
Country
Japan
City
Kobe
Country
Japan
City
Koto-Ku
Country
Japan
City
Kumamoto
Country
Japan
City
Kurashiki
Country
Japan
City
Kurume
Country
Japan
City
Kyoto
Country
Japan
City
Nagasaki
Country
Japan
City
Nagoya
Country
Japan
City
Narita
Country
Japan
City
Niigata
Country
Japan
City
Okayama
Country
Japan
City
Osaka-Sayama
Country
Japan
City
Sapporo
Country
Japan
City
Shibukawa
Country
Japan
City
Suita
Country
Japan
City
Tokushima N/A
Country
Japan
City
Tokyo
Country
Japan
City
Toyama-City
Country
Japan
City
Toyohashi
Country
Japan
City
Utsunomiya
Country
Japan
City
Yokohama
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs