Clinical trial NCT00985959: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: Multiple myeloma
Hematopoietic stem cell transplant
HSCT
Melphalan
Prednisolone
Bortezomib
JNJ-26866138
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2009-09-29
Enrollment: 101
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Dose Limiting Toxicity During the Phase I (Cycle 1)
timeFrame: 6 weeks
measure: Number of Participants With Overall Response (Complete Response [CR] + Partial Response [PR]) - Phase I and II
timeFrame: 54 weeks
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 Alone) - Phase I
timeFrame: Day 25 of Cycle 1
measure: Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 in Combination With Melphalan and Prednisolone) - Phase I
timeFrame: Day 4 of Cycle 2
measure: Maximum Observed Plasma Concentration (Cmax) of Melphalan - Phase I
timeFrame: Day 4 of Cycle 2
measure: Maximum Observed Plasma Concentration (Cmax) of Prednisolone - Phase I
timeFrame: Day 4 of Cycle 2
measure: Median Time to First Response - Phase II
timeFrame: up to 54 weeks
Other outcomes:
Locations:
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
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: