UMIN-CTR Clinical Trial

Public title

Sequential VAD (Vincristine, Adriamycin, Dexamethasone) and VD (Velcade, Dexamethasone) Induction Followed by HDT With ASCT and thalidomide maintenance for Newly Diagnosed MM

Acronym

Sequential VAD and VD Followed by HDT With ASCT and Thalidomide Maintenance for NDMM

Scientific Title

Sequential VAD (Vincristine, Adriamycin, Dexamethasone) and VD (Velcade, Dexamethasone) Induction Followed by HDT With ASCT and thalidomide maintenance for Newly Diagnosed MM

Scientific Title:Acronym

Sequential VAD and VD Followed by HDT With ASCT and Thalidomide Maintenance for NDMM

Region

Japan

Condition

Newly Diagnosed Multiple Myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Primary Objective is to assess the response rate of sequential VD (Velcade, Dexamethasone) induction therapy as a first line treatment for the patients with multiple myeloma

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

1.To assess the response rate of patients given sequential VAD and VD induction followed by high dose therapy with autologous stem cell transplantation
2.To assess the toxicities of sequential VAD and VD induction chemotherapy, high dose therapy with autologous stem cell transplantation

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

Drug: velcade

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

15

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

1.Previously untreated newly diagnosed patients with MM (stage II-III)
2.Age 15-65
3.Eastern Cooperative Oncology Group Performance Status 0-2
4.EF > 50%, FVC and FEV > 50%, DLCO >50%
5.Platelet count 100 x 109/L (pretreatment platelet transfusion is not allowed, while transfusion during the treatment is permitted), hemoglobin 8 g/dL (Prior RBC transfusion or recombinant human erythropoietin use is allowed), absolute neutrophil count (ANC) 1.5 x 109/L
6.Adequate liver function (bilirubin < UNL(Upper Normal Limit) x 2 and ALT/AST < UNL x 3)
7.Adequate renal function (serum creatinine < UNL x 1.5 or creatine clearance > 60 ml/min)
8.Signed the informed consent, have the will and ability to follow the protocol.

Key exclusion criteria

1. History of allergic reaction attributable to compounds containing boron or mannitol
2. Known hypersensitivity to thalidomide or dexamethasone
3. Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3
4. Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
5. Acute severe infection requiring antibiotic therapy
6. Previous cancer history (except in situ carcinoma of cervix or basal cell cancer of skin)
7. Pregnancy or breastfeeding
8. Active ulcer detected by gastroscopy (gastroscopy is not routine in all patients, only to patients with symptoms of ulcer disease and/or history of previous ulcer therapy and/or physician's discretion)
9. Previous renal transplantation
10. Recurrent deep vein thrombosis or pulmonary embolism
11. Uncontrolled diabetes mellitus
12. Receipt of extensive radiation therapy within 4 weeks ((Extensive means RT to more than 2 anatomic sites).

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Hisashi Sakamaki

Organization

Tokyo Metroplolitan Komagome Hospital

Division name

Sub-director

Zip code

Address

3-18-22 Hinkomagome Bunkyo-ku Tokyo 1138677 Japan

TEL

03-3823-2101

Email

Name of contact person

1st name
Middle name
Last name	kazuteru ohashi

Organization

Tokyo Metroplolitan Komagome Hospital

Division name

Hematology Division

Zip code

Address

TEL

03-3823-2101

Homepage URL

Email

k.ohashi@cick.jp

Institute

Ochanomizu blood study committee

Institute

Department

Personal name

Organization

NPO Ibaraki blood, tumor, palliative care study committee

Organization

Division

Category of Funding Organization

Non profit foundation

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

お茶の水血液検討会

Date of disclosure of the study information

2009

Year

11

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

Enrolling by invitation

Date of protocol fixation

2009

Year

10

Month

05

Day

Date of IRB

Anticipated trial start date

2010

Year

11

Month

01

Day

Last follow-up date

2013

Year

10

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

10

Month

09

Day

Last modified on

2010

Year

10

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003185