UMIN-CTR Clinical Trial

Public title

Feasibility and efficacy of triplet regimen
in transplant-ineligible NDMM patients

Acronym

MMM02 "Triplet for elderly MM" study

Scientific Title

Feasibility and efficacy of triplet regimen
in transplant-ineligible NDMM patients

Scientific Title:Acronym

MMM02 "Triplet for elderly MM" study

Region

Japan

Condition

Multiple myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To examine the safety and efficacy of triplet induction therapy using dose-adjusted
VRd or IRd in transplant-ineligible newly diagnosed multiple myeloma patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

CR rate after the completion of the induction therapy

Key secondary outcomes

1) Response rate (VGPR, MRD negative) after the completion of the induction therapy
2) Adverse events
3) Quality of life at the time of the enrollment, after 6 courses of the induction therapy, and after the completion of the induction 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

0. Determination of the Frailty score and
the drug dose.
0-1. Frailty score
Determine the frailty score based on age, Charlson index, ADL score, and IADL score.
0-2. Determine the drug dosages based on the frailty score.
0-3. Assess the baseline QOL.

1. Start of the treatment

2. Induction therapy
2-1. DA-VRd (q28 days)
-Lenalidomide X mg/body days 1-21
-Bortezomib X mg/m2 sc days 1, 8, 15 (days 1, 15 for frail patients)
-Dex X mg/body po on days 1, 2, 8, 9, 15, 16, 22, 23
2-2. Switch to IRd if patients are intolerant to VRd.
-Lenalidomide X mg/body days 1-21
-Ixazomib X mg/m2 sc days 1, 8, 15
-Dex X mg/body po on days 1, 2, 8, 9, 15, 16, 22, 23
2-3. Assess the response and QOL after 6 courses.
2-4. Continue DA-VRd or IRd for 6 more courses.
2-5. Assess the response and QOL after 12 courses.

3. Maintenance therapy

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Multiple myeloma patients diagnosed with IMWG criteria (2014), who are 65 or older, or autologous transplant-ineligible due to comorbidities.
2) Patients with measurable disease.
3) Laboratory data.
Neutrophil > 1000/mm3
Hb > 8.0g/dL
Platelet > 75000/mm3
T-Bil < 1.5x UNL
AST, ALT < 3x UNL
Ccr > 30mL/min
4) Performance Status: 0-2

Key exclusion criteria

1) Smoldering or IgM myeloma, solitary plasmacytoma, plasma cell leukemia, POEMS syndrome, WM
2) CNS involvement
3) HIV+, HBs Ag+, or HCV Ab+
4) Severe abnormality in the liver, kidney, cardiac, or pulmonary functions. Severe diabetes, hypertension, or infection.
5) Severe psychotic disorders.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Satoshi Yoshihara

Organization

Hyogo College of Medicine

Division name

Department of Transfusion and Cellular Therapy

Zip code

Address

1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan

TEL

0798-45-6348

Email

yoshihar@hyo-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Satoshi Yoshihara

Organization

Hyogo College of Medicine

Division name

Department of Transfusion Medicine and Cellular Therapy

Zip code

Address

1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan

TEL

0798-45-6348

Homepage URL

Email

yoshihar@hyo-med.ac.jp

Institute

Hyogo College of Medicine

Institute

Department

Personal name

Organization

Hyogo College of Medicine

Organization

Division

Category of Funding Organization

Self funding

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

2017

Year

07

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

Preinitiation

Date of protocol fixation

2017

Year

06

Month

21

Day

Date of IRB

Anticipated trial start date

2017

Year

07

Month

15

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

06

Month

28

Day

Last modified on

2017

Year

06

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031916