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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)

Information source: Janssen Pharmaceutical K.K.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: JNJ-26866138 0.7 mg/m2 (Drug); JNJ-26866138 1.0 mg/m2 (Drug); JNJ-26866138 1.3 mg/m2 (Drug); Melphalan (Drug); Prednisolone (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Janssen Pharmaceutical K.K.

Official(s) and/or principal investigator(s):
Janssen Pharmaceutical K.K., Japan Clinical Trial, Study Director, Affiliation: Janssen Pharmaceutical K.K.

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).

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of Participants With Dose Limiting Toxicity During the Phase I (Cycle 1)

Number of Participants With Overall Response (Complete Response [CR] + Partial Response [PR]) - Phase I and II

Secondary outcome:

Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 Alone) - Phase I

Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 in Combination With Melphalan and Prednisolone) - Phase I

Maximum Observed Plasma Concentration (Cmax) of Melphalan - Phase I

Maximum Observed Plasma Concentration (Cmax) of Prednisolone - Phase I

Median Time to First Response - Phase II

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.

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

Additional Information

Starting date: July 2008
Last updated: October 31, 2013

Page last updated: August 23, 2015

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