UMIN-CTR Clinical Trial

Public title

Efficacy and safety of new drugs for induction, autologous stem cell transplantation, and consolidation therapy in elderiy patients with newly diagnosed symptomatic multiple myeloma.

Acronym

FBMTG-EMM13

Scientific Title

Efficacy and safety of new drugs for induction, autologous stem cell transplantation, and consolidation therapy in elderiy patients with newly diagnosed symptomatic multiple myeloma.

Scientific Title:Acronym

FBMTG-EMM13

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 new drugs in elderly patients with newly diagnosed multiple myeloma

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Response rate: sCR+CR+VGPR rate 100 days after autologous PBSCT

Key secondary outcomes

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
1-2 cycles: Bortezomib 1.3mg/m2 sc (day1,4,8,11), cyclophosphamide 500mg/m2 po/iv (day1, 8), dexamethasone 40mg/body po/iv (day 1,4,8,11)
3-4 cycles: Bortezomib 1.3mg/m2 sc (day1,8,15,22), cyclophosphamide 300mg/m2 po/iv (day1,8,15,22), dexamethasone 40mg/body po/iv (day1,8,15,22).

PBSC harvest: Cyclophosphamide 1.5g/m2 div (day 1,2)

High dose chemotherapy and PBSCT: Bortezomib 1.3mg/m2 sc (day-4,-1). L-PAM 70mg/m2 div (day -3,-2). PBSCT (day 0)

Consolidation therapy (2 cycles): Bortezomib 1.3mg/m2 sc (day1,8,15,22), thalidomide 100mg/body p.o. (day1-35), and dexamethasone 40mg/boby po/iv (day1,8,15,22).

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

66

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Symptomatic multiple myeloma diagnosed by the criteria of International Myeloma Working Group(IMWG).
2) Measureable M protein in serum or urine.
3) ECOG performance status of 0 or 2 (PS 3 possible only for osteolytic lesions.)
4) Age 66-75 years
5) Adequate organ function
6) A life expectancy of at least 3 months
7) Female patients with post menoposal status and the last menstrual period>12 months prior to enrollment in trial, or patients who agree to contraception during the study.
8) Voluntary written informed consent

Key exclusion criteria

1) Nonsecretory MM and plasma cell leukemia.
2) Known human immunodeficiency virus (HIV) infection or active hepatitis A, B or C.
3) Serious concurrent uncontrolled medical disorder. (hepatic dysfunction, renal failure, cardiac dysfunction, pulmonary dysfunction diabetes, hypertension and infectious diseases)
4) Peripheral neuropathy and neuropathic pain >=Grade 2(CTCAE ver.4.0).
5) History of malignant tumors (except for completely resected in situ carcinoma) during the previous 5 years.
6) Severe uncontrolled psychiatric disorder or illness.
7) Pregnant or lactating female
8) History of hypersensitivity to mannitol or boron.
9) Patients with pneumonia, pulmonary fibrosis or bilateral interstitial abnormalities.
10) Prior steroids treatment (allowed if short term treatment for their general condition or reduction the number of cancer cells)
11) Unwillingness or inability to follow the procedures required in the protocol.

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Toshihiro Miyamoto

Organization

Kyushu University Hospital

Division name

Hematology and Oncology

Zip code

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan

TEL

092-642-5230

Email

fbmtg@intmed1.med.kyushu-u.ac.jp

Name of contact person

1st name
Middle name
Last name	FBMTG Study Office

Organization

Fukuoka Blood and Marrow Transplantation Group

Division name

EMM13 DC

Zip code

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan

TEL

092-642-5315

Homepage URL

Email

fbmtg@intmed1.med.kyushu-u.ac.jp

Institute

Fukuoka Blood and Marrow Transplantation Group

Institute

Department

Personal name

Organization

Janssen Pharmaceutical K.K.

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

Date of disclosure of the study information

2013

Year

03

Month

06

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

2013

Year

01

Month

25

Day

Date of IRB

Anticipated trial start date

2013

Year

06

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

03

Month

05

Day

Last modified on

2019

Year

03

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011878