LBCTR : Trial details

A multicenter, randomized, open-label Phase 2 study evaluating the safety and efficacy of three different regimens of oral panobinostat in combination with subcutaneous bortezomib and oral dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma who have been previously exposed to immunomodulatory agents

Current status: Approved | Date registered: 11/01/2019

History: 12/11/2018 History: 12/11/2018 History: 12/11/2018 History: 12/11/2018 History: 12/11/2018 History: 12/11/2018 Current: 12/11/2018

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Main Information

Primary registry identifying number

LBCTR2019010183

Protocol number

CLBH589D2222

MOH registration number

5241/ص

Trial already registered with the MoPH

Study registered at the country of origin

Type of registration

Retrospective

Type of registration: Justify

LCTR was already initiated, original file was previously submitted by Paper

Date of registration in national regulatory agency

12/07/2016

Primary sponsor

Novartis Pharma Services Inc.

Primary sponsor: Country of origin

Novartis Pharmaceuticals

Public title

A multicenter, randomized, open-label Phase 2 study evaluating the safety and efficacy of three different regimens of oral panobinostat in combination with subcutaneous bortezomib and oral dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma who have been previously exposed to immunomodulatory agents

Acronym

PANORAMA 3

Scientific title

“A multicenter, randomized, open-label Phase 2 study evaluating the safety and efficacy of three different regimens of oral panobinostat in combination with subcutaneous bortezomib and oral dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma who have been previously exposed to immunomodulatory agents”

Acronym

Brief summary of the study: English

Brief Summary: The purpose of this study is to investigate the safety and efficacy of three different regimens of PAN (20 mg TIW, 20 mg BIW, and 10 mg TIW) in combination with s.c. BTZ and Dex and to provide exposure, safety and efficacy data to identify the optimal regimen of PAN in a randomized, 3-arm parallel design. This study will also assess the impact of administering s.c. BTZ (in combination with PAN and Dex) twice weekly for 4 cycles, and then weekly starting from Cycle 5 until disease progression in patients ≤ 75 years of age. Patients > 75 years of age will receive for the entire treatment period s.c. BTZ weekly (in combination with PAN and Dex) until disease progression. Patients will be treated until disease progression or until they discontinue earlier due to unacceptable toxicity or for other reasons. Patients who discontinued study treatment for reasons other than disease progression will be followed for efficacy every 6 weeks. All patients will be followed for survival until the last patient entering long-term follow-up has completed a 3 year survival follow-up or discontinued earlier.

Brief summary of the study: Arabic

دراسة مرحلة ثانية متعددة المراكز و عشوائيّة التوزيع ومفتوحة اللصاقة لتقييم سلامة وفعاليّة ثلاثة أنظمة علاجيّة مختلفة من بانوبينوستات عن طريق الفم بالاشتراك مع بورتيزوميب تحت الجلد وديكساميثازون عن طريق الفم لدى مرضى مصابين بالورم النقوي المتعدد المعاود أو المعاود/المقاوم للعلاج تعرّضوا في السابق لأدوية مناعيّة مكيّفة

Health conditions/problem studied: Specify

Patient with Relapsed or Relapsed-and-refractory Multiple Myeloma

Interventions: Specify

Drug: Panobinostat capsules Drug: bortezomib injection Drug: dexamethasone tablets

Key inclusion and exclusion criteria: Inclusion criteria

Inclusion Criteria: •multiple myeloma as per IMWG 2014 definition •requiring treatment for relapsed or relapsed/refractory disease •measurable disease based on central protein assessment •1 to 4 prior lines of therapy •prior IMiD exposure •acceptable lab values prior to randomization

Key inclusion and exclusion criteria: Gender

Both

Key inclusion and exclusion criteria: Age minimum

Key inclusion and exclusion criteria: Age maximum

Key inclusion and exclusion criteria: Exclusion criteria

Exclusion Criteria: •primary refractory myeloma •refractory to bortezomib •concomitant anti-cancer therapy (other then BTZ/Dex and bisphosphonates •prior treatment with DAC inhibitors •Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months prior to randomization) •Unresolved diarrhea ≥ CTCAE grade 2 or presence of medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease) Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study

Type

Interventional

Type of intervention

Pharmaceutical

Trial scope

Other

Trial scope: Specify scope

Efficacy and safety

Study design: Allocation

Randomized controlled trial

Study design: Masking

Open (masking not used)

Study design: Control

Dose comparison

Study phase

Study design: Purpose

Treatment

Study design: Assignment

Parallel

IMP has market authorization

Yes, Worldwide

IMP has market authorization: Specify the countries

Both US FDA and EU approved

Name of IMP

Panobinostat ( FARYDAK)

Year of authorization

2015

Month of authorization

Type of IMP

Others

Type of IMP: Specify

HDAC inhibitor

Pharmaceutical class

Panobinostat has been developed as a pan-HDAC inhibitor of Class I, II and IV histone deacetylases (HDACs) involved in the deacetylation of histone and non-histone cellular proteins.

Therapeutic indication

patients with relapsed or relapsed/refractory multiple myeloma

Therapeutic benefit

Overall response rate (ORR) up to 8 cycles

Biospecimen retention

Samples with DNA**

Biospecimen description

Samples will be sent to Covance central Lab in Switzerland as per study protocol to assess patient disease response following treatment administration.

Target sample size

Actual enrollment target size

Date of first enrollment: Type

Actual

Date of first enrollment: Date

10/05/2017

Date of study closure: Type

Actual

Date of study closure: Date

04/02/2020

Recruitment status

Recruiting

Date of completion

IPD sharing statement plan

IPD sharing statement description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

Additional data URL

https://clinicaltrials.gov/ct2/show/NCT02654990?term=clbh589d2222&rank=1

Summary Results

Secondary Identifying Numbers

Full name of issuing authority	Secondary identifying number
National Institute of Health (clinicaltrials.gov)	NCT02654990

Sources of Monetary or Material Support

Name
Novartis Pharma Services Inc.

Secondary Sponsors

Name
NA

Contact for Public/Scientific Queries

Contact type	First name	Last name	Address	Country	Telephone	Email	Affiliation
Public	Fadi	Farhat	Saida	Lebanon	+961 3 753 155	drfadi.trials@gmail.com	Hammoud Hospital
Scientific	Hind	Khairallah	Beirut	Lebanon	+961 1 512002 Ext. 271	Hind.Khairallah@fattal.com.lb	Khalil Fattal et Fils s.a.l.
Public	Fadi	El Karak	Mansourieh	Lebanon	+961 3 061 621	felkarak@yahoo.com	Bellevue Medical Center
Public	Joseph	Kattan	Beirut	Lebanon	+961 1424942	jkattan62@hotmail.com	Hotel Dieu De France

Centers/Hospitals Involved in the Study

Center/Hospital name	Name of principles investigator	Principles investigator speciality	Ethical approval
Hammoud Hospital	Dr Fadi Farhat	Hematology Oncology	Approved
Bellevue Medical Center	Dr Fadi El Karak	Hematology Oncology	Approved
Hotel Dieu De France	Dr Joseph Kattan	Hematology Oncology	Approved

Ethics Review

Ethics approval obtained	Approval date	Contact name	Contact email	Contact phone
Hotel Dieu de France	07/04/2016	Joseph Kattan	jkattan62@hotmail.com	009613635913
Bellevue Medical Center	22/08/2016	Fadi El Karak	felkarak@yahoo.com	00961 3 061 621
Hammoud Hospital University Medical Center	08/05/2017	Fadi Farhat	drfadi.trials@gmail.com	00961 3 753 155

Countries of Recruitment

Name
Lebanon
Republic of Korea
Netherlands
Norway
Poland
Portugal
Russian Federation
Spain
Sweden
Thailand
Australia
Belgium
Brazil
Canada
Czech Republic
France
Germany
Greece
Hungary
Italy
Turkey
United States of America

Health Conditions or Problems Studied

Condition	Code	Keyword
Multiple myeloma	Multiple myeloma (C90.0)	MM

Interventions

Intervention	Description	Keyword
Reference table 7.1 of the study protocol: History taking/ Lab procedures/ Radiology assessment/ medication administration/ ECG / Questionnaire completion/ Bone marrow aspirate procedure/ Assessment of adverse events	Informed consent form	ICF/ Blood test/ Vital signs

Primary Outcomes

Name	Time points	Measure
1.Overall response rate (ORR) up to 8 cycles	[ Time Frame: up to 8 cycles per patient, approximately 30 months ]	up to 8 cycles

Key Secondary Outcomes

Name	Time points	Measure
overall response rate	through out study	Through out the study
Progression-free survival	Progression free survival	PFS

Trial Results

Summary results in Lebanon

Study results globally

Date of posting of results summaries

Date of first journal publication of results

Results URL link

Baseline characteristics

Participant flow

Adverse events

Outcome measures

URL to protocol files

Link(s) to publications related to the study

Changes History

Change	Date

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Trial details