UMIN-CTR Clinical Trial

Public title

Phase 2 study of clarithromycin, pomalidomide and dexamethasone(ClaPD) for patients with relapsed or refractory multiple myeloma

Acronym

ClaPD for RRMM

Scientific Title

Phase 2 study of clarithromycin, pomalidomide and dexamethasone(ClaPD) for patients with relapsed or refractory multiple myeloma

Scientific Title:Acronym

ClaPD for RRMM

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 ClaPD therapy for relapsed or refractory multiple myeloma patients

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Overall response rate

Key secondary outcomes

Progression-free survival,Overall survival,Complete response rate,Stringent complete response rate,Very good partial response rate,Partial response rate,

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

<ClaPD>
Clarithromycin 400mg x 2/day(Day1-28) p.o
Pomalidomide 1-4mg/day(Day1-21) p.o
Dexamethasone 20-40mg/day(Day1, 8, 15, 22) p.o
28day/cycle until PD

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

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1)aged 20 and more than 20 years old ,and 80 and less than 80 years old
(2)progression disease cases after latest chemotherapy who received bortezomib and lenalidomide before.
(3)having measurable paraprotein; M protein>=0.5g/dL (IgG,IgA,IgM),or M protein>=0.05g/dL (IgD), or Urine M protein>200mg/day
(4)performance status:0-2,or 3 due to osteolytic lesions alone
(5)coexisting conditions are eligible as follows:
･serum AST, ALT< 3 times the ULN
･neutrophil count; more than 1,000/mm3
･platelet count; more than 75,000/mm3
･serum AST, ALT< 5 times the ULN
･percutaneous oxygen saturation>=93%
(6)expected surviving more than 1 month
(7)patients who are observed RevMate
(8)patients who have given consent to participate in the study of their own free will after having received from the principal investigator or subinvestigator (and the study collaborator) full information about the purpose and procedure of the study using the Informed Consent Form and Patient Information

Key exclusion criteria

Pregnancy or Lactation
Patients with plasma cell leukemia, cardiac amyloidosis and POEMS syndrome
Patients who have peripheral neuropathy or peripheral neuropathic pain of grade 3 or more
Patients with severe hepatic dysfunction, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, and uncontrolled hypertension
Patients with tuberculosis, herpetic keratoconjunctivitis, systemic fungal infection, and with other active infections
Patients with acute myocardial infarction within 6 months, with deep venous thrombosis or with pulmonary embolism within 3 years
Patients who have had a complication of active double cancer within the past 5 years
HBs antigen positive,HCV antibody positive, HIV antibody positive patients
Patients with a clinical picture of interstitial pneumonia or fibroid lung or an abnormal bilateral interstitial abnormality on chest CT scan regardless of the presence or absence of symptoms
Other patients who are,in the opinion of the caring investigator, unfit for enrollment in the study

Target sample size

34

Name of lead principal investigator

1st name
Middle name
Last name	Kiyoshi Ando

Organization

Tokai University

Division name

Division of Hematology/Oncology

Zip code

Address

143 shimokasuya, Isehara, Kanagawa

TEL

0463-93-1121

Email

andok@keyaki.cc.u-tokai.ac.jp

Name of contact person

1st name
Middle name
Last name	Hiroki Numata

Organization

Tokai University

Division name

Division of Hematology/Oncology

Zip code

Address

143 shimokasuya, Isehara, Kanagawa

TEL

0463-93-1121

Homepage URL

Email

gensasuke@yahoo.co.jp

Institute

Tokai University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

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

東海大学病院（神奈川県）、海老名総合病院（神奈川県）、秦野赤十字病院（神奈川県）、小澤病院（神奈川県）

Date of disclosure of the study information

2016

Year

09

Month

26

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

Date of protocol fixation

2015

Year

06

Month

22

Day

Date of IRB

Anticipated trial start date

2015

Year

07

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

2016

Year

09

Month

26

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=R000027818