UMIN-CTR Clinical Trial

Public title

Bortezomib induction, consolidation and maintenance therapy in patients with newly diagnosed multiple myeloma

Acronym

KHSG MM13

Scientific Title

Bortezomib induction, consolidation and maintenance therapy in patients with newly diagnosed multiple myeloma

Scientific Title:Acronym

KHSG MM13

Region

Japan

Condition

Multiple myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of Bortezomib containing induction, consolidation and maintenance therapy, and to investigate the efficacy of detection of minimal rsidual disease.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

CR rate 100 days after autologous PBSCT

Key secondary outcomes

ORR after indecution therapy
ORR after PBSCH
ORR after 100 days after PBSCT
ORR after consolidation therapy
ORR during maiteinance therapy at 6, 12, 18, 24 months
2-years progression free survival
2 years overall survival
Time to pregression
Incidence of adverse events
mCR rate after induction, PBSCH, PBSCT, consolidation and maintenance therapy
Detection of Minimal residual disease in PBSCH products
Numer of CD34 cells harvested
Incidence of graft failure
Completion rate of maintenance therapy

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Induction therapy (1st and 2nd courses)
Bortezomib 1.3mg/m2 s.c (day1, 8 ,15, 22), cyclophosphamide 300mg/m2 p.o (day1, 8, 15, 22), dexamethasone 40mg/body p.o (day 1-3, 8-10 ,15-17, 22-24) every 28 days.

Induction therapy (2nd and 3rd courses)
Bortezomib 1.3mg/m2 s.c (day1, 8 ,15, 22), cyclophosphamide 300mg/m2 p.o (day1, 8, 15, 22), dexamethasone 40mg/body p.o (day 1, 8 ,15, 22) every 28 days.

PBSC harvest
Cyclophosphamide 2.0g/m2 d.i.v (day 1 , 2) .

PBSCT with high dose chemotherapy
L-PAM 100mg/m2 d.i.v (day -3,-2).

Consolidation therapy (3 courses) Bortezomib 1.3mg/m2 s.c (day1, 8 ,15, 22), cyclophosphamide 300mg/m2 p.o (day1, 8, 15, 22), dexamethasone 40mg/body p.o (day 1, 8 ,15, 22) every 28 days.

Maintenance therapy (uo to 2 years)Bortezomib 1.3mg/m2 s.c every 2 weeks.

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

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

1, Diagnosis of symptomatic multiple myeloma based on IMWG criteria. No prior therapy for MM.
3, Measurable M protein in serum or urin.
4, Age 20-65 years.
5, Performance status ECOG 0-2 (PS 3 possible only for osteolytic lesion).
6, Adequate organ functin.
7, Estimated life-expectancy greater than 3 months.
8, Sined, informed consent.

Key exclusion criteria

1, Non-secretary multiplemyeloma and plasma cell leukemia
2, HIV antibody positive, HBsAg positive, HBV-DNA positive, and HCV antibody positive.
3, Known hypersensivity to mannitol or boron.
4, Pregnant or breast-feeding women.
5, Active malignancy within last 5 years.
6, Serious psychiatric disordes or illness that could potentially interfere with the completion of treatment according to this protocol.
7, Active infection or serious co-morbid medical condition.
8, Interstitial pneumonitis or lung fibrosis by the clinical findings, abnormal shadow of chest CT.
9, History of sever hypersensivity to drugs.
10,Participants who are recoginized as inadaptable for this protocol.

Target sample size

48

Name of lead principal investigator

1st name
Middle name
Last name	Akifumi Takaori-Kondo

Organization

Kyoto University Hospital

Division name

Department of Hematology/Oncology

Zip code

Address

54 Shogoin-Kawaharacho, Sakyo, Kyoto, 606-8507, JAPAN

TEL

075-751-3150

Email

atakaori@kuhp.kyoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Kobayashi Masayuki

Organization

Kyoto University Hospital

Division name

Department of Hematology/Oncology

Zip code

Address

54 Shogoin-Kawaharacho, Sakyo, Kyoto, 606-8507, JAPAN

TEL

075-751-3164

Homepage URL

http://clisss.medical-edc.net/cybord/

Email

mkobayas@kuhp.kyoto-u.ac.jp

Institute

Kyoto University Hematology Study Group

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2013

Year

05

Month

20

Day

Date of IRB

Anticipated trial start date

2013

Year

07

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

04

Month

19

Day

Last modified on

2018

Year

04

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012054