NCT00985959 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1
Status at capture: COMPLETED
Registry last update: 2013-12-02

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Median Time to First Response - Phase II

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 20 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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.
intervention Names
Drug: JNJ-26866138 0.7 mg/m2
Drug: Melphalan
Drug: Prednisolone
label
Phase I: JNJ-26866138 0.7 mg/m2
type
EXPERIMENTAL
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
intervention Names
Drug: JNJ-26866138 1.0 mg/m2
Drug: Melphalan
Drug: Prednisolone
label
Phase I: JNJ-26866138 1.0 mg/m2
type
EXPERIMENTAL
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
intervention Names
Drug: JNJ-26866138 1.3 mg/m2
Drug: Melphalan
Drug: Prednisolone
label
Phase I: JNJ-26866138 1.3 mg/m2
type
EXPERIMENTAL
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 Names
Drug: JNJ-26866138 1.3 mg/m2
Drug: Melphalan
Drug: Prednisolone
label
Phase II: JNJ-26866138 1.3 mg/m2
type
EXPERIMENTAL

interventions

arm Group Labels
Phase I: JNJ-26866138 0.7 mg/m2
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.
name
JNJ-26866138 0.7 mg/m2
other Names
bortezomib
type
DRUG
arm Group Labels
Phase I: JNJ-26866138 1.0 mg/m2
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
name
JNJ-26866138 1.0 mg/m2
other Names
bortezomib
type
DRUG
arm Group Labels
Phase I: JNJ-26866138 1.3 mg/m2
Phase II: JNJ-26866138 1.3 mg/m2
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.
name
JNJ-26866138 1.3 mg/m2
other Names
bortezomib
type
DRUG
arm Group Labels
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
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
name
Melphalan
type
DRUG
arm Group Labels
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
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
name
Prednisolone
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 101
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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

secondary Outcomes

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)
measure
Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 Alone) - Phase I
time Frame
Day 25 of Cycle 1
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)
measure
Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 in Combination With Melphalan and Prednisolone) - Phase I
time Frame
Day 4 of Cycle 2
description
Cmax of melphalan at dose of 9 mg/m2 on Cycle 2/Day 4
measure
Maximum Observed Plasma Concentration (Cmax) of Melphalan - Phase I
time Frame
Day 4 of Cycle 2
description
Cmax of Prednisolone at dose of 60 mg/m2 on Cycle 2/Day 4
measure
Maximum Observed Plasma Concentration (Cmax) of Prednisolone - Phase I
time Frame
Day 4 of Cycle 2
description
Time to first response is the duartion of time required to achieve first response to treatment
measure
Median Time to First Response - Phase II
time Frame
up to 54 weeks

Full 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.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice