UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007803
Receipt number R000009174
Scientific Title The efficacy and safety of subcutaneous injection of bortezomib combined with doxorubicin and dexamethasone for untreated multiple myeloma patients.
Date of disclosure of the study information 2012/04/21
Last modified on 2012/04/20 18:44:20

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Basic information

Public title

The efficacy and safety of subcutaneous injection of bortezomib combined with doxorubicin and dexamethasone for untreated multiple myeloma patients.

Acronym

The efficacy and safety of sPAD

Scientific Title

The efficacy and safety of subcutaneous injection of bortezomib combined with doxorubicin and dexamethasone for untreated multiple myeloma patients.

Scientific Title:Acronym

The efficacy and safety of sPAD

Region

Japan


Condition

Condition

multiple myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The efficacy, safety, and the predictive factors of subcutaneous injection of bortezomib combined with doxorubicin and dexamethasone for untreated multiple myeloma patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

efficacy

Key secondary outcomes

safety
complete response rate
progression free survival
Blood concentration of bortezomib overall survival


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

treatment protocol

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

According to the International Myeloma Working Group (IMWG) criteria, patients younger than 75 years with symptomatic MM were eligible for this trial.

Key exclusion criteria

The exclusion criteria were a serum creatinine level>2.05 mg/dL, liver dysfunction (e.g., a serum total bilirubin level>2.0 mg/dL, or serum aspartate/alanine aminotransferase or alkaline phosphatase levels more than 2.5 times the upper limit of normal), grade 3 or worse peripheral neuropathy, significant comorbidity that would preclude ASCT, poor performance status (>grade 3), and a history of any other malignancy with the exception of basal cell carcinoma and stage I cervical cancer.

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoki Takezako

Organization

National Hospital Organization Disaster Medical Center

Division name

Hematology

Zip code


Address

3256 Midori Tachikawa Tokyo Japan

TEL

+81-42-526-5511

Email



Public contact

Name of contact person

1st name
Middle name
Last name Naoki Takaezako

Organization

National Hospital Organization Disaster Medical Center

Division name

Hematology

Zip code


Address

3256 Midori Tachikawa Tokyo Japan

TEL

+81-42-526-5511

Homepage URL


Email

ntakezak@tdmc.hosp.go.jp


Sponsor or person

Institute

National Hospital Organization Disaster Medical Center

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

国立病院機構 災害医療センター


Other administrative information

Date of disclosure of the study information

2012 Year 04 Month 21 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2011 Year 06 Month 30 Day

Date of IRB


Anticipated trial start date

2011 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 04 Month 20 Day

Last modified on

2012 Year 04 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009174


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name