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

NCT ID: NCT00985959

Last Updated: 2013-12-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-06-30

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma

Keywords

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Multiple myeloma Hematopoietic stem cell transplant HSCT Melphalan Prednisolone Bortezomib JNJ-26866138

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

JNJ-26866138 0.7 mg/m2

Intervention Type DRUG

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.

Melphalan

Intervention Type DRUG

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

Prednisolone

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

JNJ-26866138 1.0 mg/m2

Intervention Type DRUG

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

Melphalan

Intervention Type DRUG

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

Prednisolone

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

JNJ-26866138 1.3 mg/m2

Intervention Type DRUG

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.

Melphalan

Intervention Type DRUG

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

Prednisolone

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

JNJ-26866138 1.3 mg/m2

Intervention Type DRUG

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.

Melphalan

Intervention Type DRUG

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

Prednisolone

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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

Intervention Type 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.

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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bortezomib bortezomib bortezomib

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

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Fukuoka, , Japan

Site Status

Hiroshima, , Japan

Site Status

Hitachi, , Japan

Site Status

Isehara, , Japan

Site Status

Kamogawa, , Japan

Site Status

Kanazawa, , Japan

Site Status

Kawagoe, , Japan

Site Status

Kobe, , Japan

Site Status

Kōtoku, , Japan

Site Status

Kumamoto, , Japan

Site Status

Kurashiki, , Japan

Site Status

Kurume, , Japan

Site Status

Kyoto, , Japan

Site Status

Nagasaki, , Japan

Site Status

Nagoya, , Japan

Site Status

Narita, , Japan

Site Status

Niigata, , Japan

Site Status

Okayama, , Japan

Site Status

Ōsaka-sayama, , Japan

Site Status

Sapporo, , Japan

Site Status

Shibukawa, , Japan

Site Status

Suita, , Japan

Site Status

Tokushima, , Japan

Site Status

Tokyo, , Japan

Site Status

Toyama, , Japan

Site Status

Toyohashi, , Japan

Site Status

Utsunomiya, , Japan

Site Status

Yokohama, , Japan

Site Status

Countries

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Japan

Other Identifiers

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JNJ-26866138-JPN-MM-102

Identifier Type: OTHER

Identifier Source: secondary_id

CR014776

Identifier Type: -

Identifier Source: org_study_id