UMIN-CTR Clinical Trial

Public title

Phase II study of VCD therapy in patients with newly diagnosed, transplantation-eligible symptomatic multiple myeloma.

Acronym

Shimousa MM-01 VCD study

Scientific Title

Phase II study of VCD therapy in patients with newly diagnosed, transplantation-eligible symptomatic multiple myeloma.

Scientific Title:Acronym

Shimousa MM-01 VCD study

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 of VCD (Velcade, cyclophosphamide and dexamethasone) therapy compared with BD (bortezomib and dexamethasone) therapy in patients with newly diagnosed, transplantation-eligible symptomatic multiple myeloma.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

CR/VGPR rate after 4 cycles of VCD therapy

Key secondary outcomes

1) Incidence of adverse events after 4 cycles of VCD therapy
2) Efficacy of peripheral blood stem cell harvest
3) Time to progression
4) Overall survival at two years after treatment
5) Treatment efficacy at two years after treatment
6) Incidence of adverse event at two years after treatment
7) Relationship between treatment efficacy at 4 cycles of VCD treatment and progression free survival (PFS)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Velcade;(Bortezomib) 1.3 mg/m2 (s.c.)
Days 1, 4, 8, 11 (cycle 1)
Days 1, 8, 15, 22 (cycle 2, 3, 4)
+
Cyclophosphamide 500 mg/m2 (div) days 1, 8
+
Dexamethasone 20 mg (p.o. or div)
Days 1, 2, 4, 5, 8, 9, 11, 12 (C-1)
Days 1, 2, 8, 9, 15, 16, 22, 23 (C-2, 3, 4)

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

18

years-old

<=

Age-upper limit

70

years-old

>=

Gender

Male and Female

Key inclusion criteria

1.Symptomatic multiple myeloma defined by IMWG criteria.
2.Measurable M protein in serum or urine
3.PS(ECOG)0-2.(Patients with poor P.S. by bone pain accompanying myeloma can be included.)
4.Age from 18 to 70 years old.
5.Main organ function is maintained
6.For female patients, postmenopausal (patients older than one year from the last menstrual period), or the proper way or surgical contraception (birth control pills, contraceptives, etc.) has the intention of contraception during the study. For male patients, to agree the appropriate method of contraception during the study.
7.voluntary written informed consent

Key exclusion criteria

1. Non-secretory MM and plasmacell leukemia.
2. Patients with HIV antibody positive, HBs antigen posiive or HCV antibody positive
3. Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection.
4. Patients with a history of active malignancy during the past 5 years.
5. Patients with psychiatric disorders such as schizophrenia etc.
6. Pregnant women, pre-menopausal women, and lactating women.
7. Patient was suspected pneumonia (Interstitial pneumonia).
8. Those who are considered as inappropriate to register by attending physicians.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Masahiro Takeuchi

Organization

Chiba University Hospital

Division name

Department of Hematology

Zip code

Address

1-8-1 Inohana, Chuo-ku, Chiba, Japan

TEL

043-225-6502

Email

m-takeuchi@faculty.chiba-u.jp

Name of contact person

1st name
Middle name
Last name	Hisashi Wakita

Organization

Japanese Red Cross Society Narita Hospital

Division name

Department of hematology and Oncology

Zip code

Address

90-1 Iida-cho, Narita, Japan

TEL

0476-22-2311

Homepage URL

Email

mm01vcd@gmail.com

Institute

Shimousa blood study group

Institute

Department

Personal name

Organization

Shimousa blood study group

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

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

千葉大学医学部附属病院（千葉県）、成田赤十字病院（千葉県）、亀田総合病院（千葉県）、旭中央病院（千葉県）、船橋中央病院（千葉県）済生会習志野病院（千葉県）、順天堂大学医学部附属浦安病院（千葉県）、金沢大学医学部附属病院（石川県）

Date of disclosure of the study information

2013

Year

01

Month

15

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

Completed

Date of protocol fixation

2012

Year

10

Month

15

Day

Date of IRB

Anticipated trial start date

2012

Year

11

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

01

Month

10

Day

Last modified on

2016

Year

07

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011425