A Study of JNJ-26866138 (Bortezomib) in Untreated Multipl... | NCT00985959

NCT00985959

ID	Type	Description	Link
JNJ-26866138-JPN-MM-102	Other Identifier	Janssen Pharmaceutical K.K., Japan

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phase I: JNJ-26866138 0.7 mg/m2	Experimental	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.	Drug: JNJ-26866138 0.7 mg/m2 Drug: Melphalan Drug: Prednisolone
Phase I: JNJ-26866138 1.0 mg/m2	Experimental	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	Drug: JNJ-26866138 1.0 mg/m2 Drug: Melphalan Drug: Prednisolone
Phase I: JNJ-26866138 1.3 mg/m2	Experimental	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	Drug: JNJ-26866138 1.3 mg/m2 Drug: Melphalan Drug: Prednisolone
Phase II: JNJ-26866138 1.3 mg/m2	Experimental	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	Drug: JNJ-26866138 1.3 mg/m2 Drug: Melphalan Drug: Prednisolone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JNJ-26866138 0.7 mg/m2	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.	Phase I: JNJ-26866138 0.7 mg/m2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	6 weeks
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	54 weeks

Secondary Outcomes

Measure	Description	Time Frame
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)	Day 25 of Cycle 1
Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 in Combination With Melphalan and Prednisolone) - Phase I

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Janssen Pharmaceutical K.K., Japan Clinical Trial	Janssen Pharmaceutical K.K.	Study Director

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Phase I - JNJ-26866138 0.7 mg/m2 Group	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
FG001	Phase I - JNJ-26866138 1.0 mg/m2 Group

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

FG0006 subjectsNumber of participants treated

FG0016 subjectsNumber of participants treated

FG00287 subjectsNumber of participants treated

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Phase I - JNJ-26866138 0.7 mg/m2 Group	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
BG001	Phase I - JNJ-26866138 1.0 mg/m2 Group	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
BG002	Phase I and II - JNJ-26866138 1.3 mg/m2 Group	Phase I: 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. Phase II: 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
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00072.7± 9.2 BG00168.5± 6.47 BG00270.9± 5.68 BG003

Age, Customized

Number

Participants

Title

Denominators

Categories

<65 years

Title	Measurements
	BG0001 BG0011 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0003 BG0013 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

Dose Limiting Toxicity set, Which includes all 18 participants in the Phase I

Posted

Number

Participants

6 weeks

ID	Title	Description
OG000	Phase I - JNJ-26866138 0.7 mg/m2 Group	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
OG001	Phase I - JNJ-26866138 1.0 mg/m2 Group	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
OG002	Phase I - JNJ-26866138 1.3 mg/m2 Group	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

Units	Counts
Participants	OG0006 OG0016 OG0026

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0021

Primary

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

Full analysis set: All participants who received at least one dose of the study medication.

Posted

Number

Participants

54 weeks

ID	Title	Description
OG000	Phase I - JNJ-26866138 0.7 mg/m2 Group	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
OG001	Phase I - JNJ-26866138 1.0 mg/m2 Group	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

Secondary

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)

Pharmacokinetics-evaluable population: 16 participants were included in pharmacokinetics-evaluable population

Posted

Mean

Standard Deviation

ng/mL

Day 25 of Cycle 1

ID	Title	Description
OG000	Phase I - JNJ-26866138 0.7 mg/m2 Group	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
OG001	Phase I - JNJ-26866138 1.0 mg/m2 Group	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
OG002	Phase I - JNJ-26866138 1.3 mg/m2 Group	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

Secondary

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)

Pharmacokinetics-evaluable population: 14 participants were included in pharmacokinetics-evaluable population during Cycle 2

Posted

Mean

Standard Deviation

ng/mL

Day 4 of Cycle 2

ID	Title	Description
OG000	Phase I - JNJ-26866138 0.7 mg/m2 Group	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
OG001	Phase I - JNJ-26866138 1.0 mg/m2 Group	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
OG002	Phase I - JNJ-26866138 1.3 mg/m2 Group	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

Secondary

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

Cmax of melphalan at dose of 9 mg/m2 on Cycle 2/Day 4

Pharmacokinetics-evaluable population: 14 participants were included in pharmacokinetics-evaluable population during Cycle 2

Posted

Mean

Standard Deviation

ng/mL

Day 4 of Cycle 2

ID	Title	Description
OG000	Melphalan	Melphalan 9 mg/m2 on day 1, 2, 3 and 4 of 6-week cycle up to 9 cycles

Units	Counts
Participants	OG00014

Secondary

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

Cmax of Prednisolone at dose of 60 mg/m2 on Cycle 2/Day 4

Pharmacokinetics-evaluable population: 14 participants were included in pharmacokinetics-evaluable population during Cycle 2

Posted

Mean

Standard Deviation

ng/mL

Day 4 of Cycle 2

ID	Title	Description
OG000	Prednisolone	Prednisolone 60 mg/m2 on day 1, 2, 3 and 4 of 6-week cycle up to 9 cycles

Units	Counts
Participants	OG00014

Secondary

Median Time to First Response - Phase II

Time to first response is the duartion of time required to achieve first response to treatment

Full analysis set: All participants who received at least one dose of the study medication.

Posted

Median

95% Confidence Interval

Days

up to 54 weeks

ID	Title	Description
OG000	Phase II - JNJ-26866138 1.3 mg/m2 Group	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

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Phase I - JNJ-26866138 0.7 mg/m2 Group	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	2	6	6	6
EG001	Phase I - JNJ-26866138 1.0 mg/m2 Group	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	2	6	6	6
EG002	Phase I - JNJ-26866138 1.3 mg/m2 Group	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	1	6	6	6
EG003	Phase II - JNJ-26866138 1.3 mg/m2 Group	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	29	87	87	87

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Bronchopulmonary aspergillosis	Infections and infestations	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG0031 events1 affected87 at risk
Herpes zoster	Infections and infestations	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Nasopharyngitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Pneumonia	Infections and infestations	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Pneumonia pneumococcal	Infections and infestations	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Septic shock	Infections and infestations	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Herpes zoster dissemin	Infections and infestations	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Enterocolitis bacterial	Infections and infestations	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Tumour lysis syndrome	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Hypophagia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Depression	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Neuropathy peripheral	Nervous system disorders	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Cataract	Eye disorders	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Glaucoma	Eye disorders	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Prinzmetal angina	Cardiac disorders	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Enterocolitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Ileus	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
Erythema multiforme	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Renal failure	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Renal failure acute	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Renal impairment	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Asthenia	General disorders	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Pyrexia	General disorders	Systematic Assessment	EG0000 events0 affected6 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	Systematic Assessment	EG0002 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG00314 affected87 at risk
Neutropenic infection	Infections and infestations	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
Leukopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0006 affected6 at risk EG0016 affected6 at risk EG0026 affected6 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0006 affected6 at risk EG0016 affected6 at risk EG0026 affected6 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0006 affected6 at risk EG0016 affected6 at risk EG0025 affected6 at risk EG003
Neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0006 affected6 at risk EG0016 affected6 at risk EG0026 affected6 at risk EG003
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0002 affected6 at risk EG0014 affected6 at risk EG0024 affected6 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	Systematic Assessment	EG0003 affected6 at risk EG0012 affected6 at risk EG0024 affected6 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0005 affected6 at risk EG0012 affected6 at risk EG0025 affected6 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 affected6 at risk EG0013 affected6 at risk EG0024 affected6 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected6 at risk EG0012 affected6 at risk EG0024 affected6 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0022 affected6 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected6 at risk EG0012 affected6 at risk EG0024 affected6 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 affected6 at risk EG0014 affected6 at risk EG0021 affected6 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0022 affected6 at risk EG003
Hyperchloraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0022 affected6 at risk EG003
Insomnia	Psychiatric disorders	Systematic Assessment	EG0001 affected6 at risk EG0012 affected6 at risk EG0022 affected6 at risk EG003
Neuropathy peripheral	Nervous system disorders	Systematic Assessment	EG0003 affected6 at risk EG0012 affected6 at risk EG0025 affected6 at risk EG003
Dysgeusia	Nervous system disorders	Systematic Assessment	EG0002 affected6 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
Dizziness	Nervous system disorders	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0023 affected6 at risk EG003
Headache	Nervous system disorders	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0022 affected6 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	Systematic Assessment	EG0002 events2 affected6 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Thrombocytosis	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Infection	Infections and infestations	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Pneumonia	Infections and infestations	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Herpes zoster	Infections and infestations	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Pharyngitis	Infections and infestations	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Hypersensitivity	Immune system disorders	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 affected6 at risk EG0012 affected6 at risk EG0021 affected6 at risk EG003
Hypercreatininaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected6 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Peripheral motor neuropathy	Psychiatric disorders	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
Somnolence	Psychiatric disorders	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Cataract	Eye disorders	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Hypotension	Vascular disorders	Systematic Assessment	EG0001 affected6 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
Hot flush	Vascular disorders	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Hypertension	Vascular disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected6 at risk EG0010 affected6 at risk EG0022 affected6 at risk EG003
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected6 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0002 affected6 at risk EG0013 affected6 at risk EG0026 affected6 at risk EG003
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0004 affected6 at risk EG0012 affected6 at risk EG0025 affected6 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0001 affected6 at risk EG0012 affected6 at risk EG0026 affected6 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0025 affected6 at risk EG003
Stomatitis	Gastrointestinal disorders	Systematic Assessment	EG0002 affected6 at risk EG0012 affected6 at risk EG0022 affected6 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	Systematic Assessment	EG0002 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Abdominal distension	Gastrointestinal disorders	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0022 affected6 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Lip dry	Gastrointestinal disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Dental caries	Gastrointestinal disorders	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Gastritis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	Systematic Assessment	EG0003 affected6 at risk EG0011 affected6 at risk EG0023 affected6 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 affected6 at risk EG0014 affected6 at risk EG0023 affected6 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 affected6 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0022 affected6 at risk EG003
Erythema multiforme	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected6 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected6 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0023 affected6 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Renal impairment	Renal and urinary disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Azotaemia	Renal and urinary disorders	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Malaise	General disorders	Systematic Assessment	EG0002 affected6 at risk EG0013 affected6 at risk EG0025 affected6 at risk EG003
Pyrexia	General disorders	Systematic Assessment	EG0002 affected6 at risk EG0011 affected6 at risk EG0026 affected6 at risk EG003
Fatigue	General disorders	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
Oedema	General disorders	Systematic Assessment	EG0001 affected6 at risk EG0011 affected6 at risk EG0022 affected6 at risk EG003
Oedema peripheral	General disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0022 affected6 at risk EG003
Pain	General disorders	Systematic Assessment	EG0002 affected6 at risk EG0012 affected6 at risk EG0022 affected6 at risk EG003
Chest pain	General disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Face oedema	General disorders	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Injection site reaction	General disorders	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
C-reactive protein increased	Investigations	Systematic Assessment	EG0002 affected6 at risk EG0013 affected6 at risk EG0024 affected6 at risk EG003
Blood lactate dehydrogenase increased	Investigations	Systematic Assessment	EG0000 affected6 at risk EG0014 affected6 at risk EG0022 affected6 at risk EG003
Weight decreased	Investigations	Systematic Assessment	EG0002 affected6 at risk EG0011 affected6 at risk EG0022 affected6 at risk EG003
Blood alkaline phosphatase increased	Investigations	Systematic Assessment	EG0004 affected6 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG0000 affected6 at risk EG0012 affected6 at risk EG0022 affected6 at risk EG003
Weight increased	Investigations	Systematic Assessment	EG0001 affected6 at risk EG0011 affected6 at risk EG0022 affected6 at risk EG003
Blood urea increased	Investigations	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Blood albumin decreased	Investigations	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Blood creatinine increased	Investigations	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Blood urea decreased	Investigations	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
Blood uric acid decreased	Investigations	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003

ID	Term
D009101	Multiple Myeloma

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006474	Hemorrhagic Disorders
D008232	Lymphoproliferative Disorders
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D000069286	Bortezomib
D008558	Melphalan
D011239	Prednisolone

Ancestor Terms

ID	Term
D001897	Boronic Acids
D000148	Acids, Noncarboxylic
D000143	Acids
D007287	Inorganic Chemicals
D001896	Boron Compounds
D009930	Organic Chemicals
D011719	Pyrazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D010649	Phenylalanine
D024322	Amino Acids, Aromatic
D000598	Amino Acids, Cyclic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Title

Denominators

Categories

Title	Measurements
	OG000100.2± 49.515

Title

Denominators

Categories

Title	Measurements
	OG0001131± 223.92

Facility	Status	City	State	ZIP	Country	Contacts
		Fukuoka			Japan