UMIN-CTR Clinical Trial

Public title

Efficacy and safety of intensified induction, autologous stem cell transplantation, consolidation and maintenance therapy in patients with newly diagnosed multiple myeloma: a phase2 study

Acronym

JSCT-MM14

Scientific Title

Efficacy and safety of intensified induction, autologous stem cell transplantation, consolidation and maintenance therapy in patients with newly diagnosed multiple myeloma: a phase2 study

Scientific Title:Acronym

JSCT-MM14

Region

Japan

Condition

Multiple myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study is to investigate efficacy and safety of novel agents in each phase of treatment in patients with newly diagnosed multiple myeloma, and to investigate efficacy of detection of minimal residual disease (MRD).

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Probability of CR after consolidation therapy.

Key secondary outcomes

1. CR + stringent CR (sCR) rates after induction therapy.
2. CR + sCR rates after autologous stem cell transplantation.
3. sCR rates after consolidation therapy.
4. CR + sCR rates after maintenance therapy.
5. 3-years progression free survival (PFS)
6. 3-years overall survival (OS)
7. 3-years time to progression (TTP)
8. Incidence of adverse events.
9. Molecular complete response (mCR) rates after autologous stem cell transplantation, consolidation and maintenance therapy.
10. Detection of minimal residual disease (MRD) in autologous grafts.

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

Induction therapy (4 courses, every 3 weeks):Bortezomib 1.3mg/m2 sc (day1,4,8,11), cyclophosphamide 500mg/m2 iv (day1, 8), dexamethasone 40mg/day po (day 1,4,8, 11).

PBSC harvest: Bortezomib 1.3mg/m2 sc (day1, 4, 8, 11). Cyclophosphamide 1.5g/m2 div (day 8, 9). G-CSF

High dose chemotherapy and PBSCT: Bortezomib 1.3mg/m2 sc (day-4,-1,3,6). HD-melphalan 100mg/m2 div (day -3,-2). PBSCT (day 0)

Consolidation therapy (2 courses, every 4 weeks): Bortezomib 1.3mg/m2 sc (day1, 8, 15), lenalidomide 25mg/body po (day1-21), and dexamethasone 40mg/day po (day1, 8, 15,22).

Maintenance therapy (every 4 weeks until PD): Lenalidomide 10mg/day po (day 1 to 21)

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. Multiple myeloma diagnosed by the criteria of International Myeloma Working Group (IMWG). Age from 20 to 65 years old.
2. Measureable M protein in serum or urine or abnormal serum k/l ratio by the serum free light chain measurement.
3. Good performance status (0-2). (Patients with poor performance status by the osteolytic lesions can be included.)
4. Main Organ function is maintained
5. Those who are evaluated to be able to survive more than 3 months.
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. In patients receiving the notice, fully briefed for the consent document and other documents given explanation about the contents of the study physician or study investigator, agreed in writing to voluntarily participate in the study by having been obtained.

Key exclusion criteria

1. Non-secretory MM, plasma cell leukemia, POEMS syndrome, and Waldenstrom Macroglobulinemia.
2. Patients with amyloidosis.
3. Patients who have been undergoing surgery or radiation treatment within 14 days before participating the study.
4. Patients who received prednisolone more than 30mg/day within 14 days before participation.
5. Involvement of central nervus system with myeloma cells
6. Patients HIV-positive, HBs antigen positive, and HCV antibody positive (except HCV-PCR negative).
7. Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection.
8. Patients with a history of active malignancy during the past 5 years.
9. Patients with psychiatric disorders such as schizophrenia etc.
10. Pregnant women, pre-menopausal women, and lactating women.
11. History of hypersensitivity to mannitol or boron.
12. Patient was suspected pneumonia (Interstitial pneumonia). Consult a respiratory specialist if necessary
13. Those who are considered as inappropriate to register by attending physicians.

Target sample size

53

Name of lead principal investigator

1st name
Middle name
Last name	Kazutaka Sunami

Organization

National Hospital Organization Okayama Medical Center

Division name

Division of Hematology

Zip code

Address

Okayama, Japan

TEL

086-294-9911

Email

jsct-office@umin.ac.jp

Name of contact person

1st name
Middle name
Last name	Kazutaka Sunami

Organization

JSCT

Division name

MM14 datacenter

Zip code

Address

3-3-13,Kyobashi,Chuou-ku,Tokyo,Japan

TEL

03-6225-2025

Homepage URL

Email

jsct-office@umin.ac.jp

Institute

Clinical Research Support Center Kyushu

Institute

Department

Personal name

Organization

Celgene Corporation

Organization

Division

Category of Funding Organization

Profit 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

札幌医科大学附属病院　腫瘍･血液内科
北海道がんセンター　血液内科
北海道大学病院　血液内科
市立札幌病院　血液内科
市立函館病院　血液内科
秋田大学医学部附属病院　輸血部･血液内科
仙台医療センター　血液内科
宮城県立がんセンター　血液内科
山形県立中央病院　血液内科
新潟大学大学病院　血液・内分泌・代謝内科
群馬大学医学部附属病院　血液内科
西群馬病院　血液内科
東京医科大学病院　血液内科
東京女子医科大学病院　血液内科
埼玉医科大学総合医療センター　血液内科
近畿大学医学部　血液・膠原病内科
近江八幡市立総合医療センター　内科
京都府立医科大学附属病院　血液・腫瘍内科
京都鞍馬口医療センター　血液内科
金沢大学医学部附属病院　血液･呼吸器内科
富山県立中央病院　血液内科
富山赤十字病院　内科
JCHO 神戸中央病院　内科
兵庫県立がんセンター　血液内科
広島大学原爆放射線医科学研究所 血液･腫瘍内科
広島西医療センター　内科
山口大学医学部附属病院　第三内科
中国中央病院　血液内科
島根大学医学部附属病院　腫瘍･血液内科
島根県立中央病院　血液腫瘍科
岡山労災病院　内科
岡山医療センター　血液内科
香川大学医学部附属病院　血液･免疫･呼吸器内科
徳島県立中央病院　血液内科
高知大学医学部附属病院　血液・呼吸器内科
松山赤十字病院　内科
愛媛県立中央病院　血液内科
四国がんセンター　血液腫瘍内科
原三信病院　血液内科
福岡赤十字病院　血液腫瘍内科
九州がんセンター　血液内科
九州大学病院　血液・腫瘍内科
千早病院　内科
浜の町病院　血液内科
福岡大学病院　腫瘍・血液・感染症内科
九州医療センター　血液内科
JCHO九州病院　血液・腫瘍内科
久留米大学病院　血液・腫瘍内科
佐賀県医療センター好生館　血液内科
熊本医療センター　血液内科
鹿児島大学病院　血液膠原病内科

Date of disclosure of the study information

2015

Year

02

Month

28

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

2015

Year

06

Month

22

Day

Date of IRB

Anticipated trial start date

2015

Year

07

Month

28

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

02

Month

04

Day

Last modified on

2016

Year

09

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019093