Back to results

Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma (PANORAMA-1)

Primary Purpose

Multiple Myeloma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Panobinostat

Bortezomib

Dexamethasone

Placebo

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Myeloma, DACi, Bortezomib, Combination, Panobinostat, LBH589D, relapsed, Velcade®, Combination,

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient has a previous diagnosis of multiple myeloma.
Patient requires retreatment for multiple myeloma
Patient has measurable M component in serum or urine at study screening

Exclusion Criteria:

Patient who has progressed under all prior lines of anti MM therapy
Patient who has been treated by bortezomib before, and did not reach at least a minor response under this therapy, or progressed under it or within 60 days of last dose
Patient has shown intolerance to bortezomib or to dexamethasone or components of these drugs or has any contraindication to one or the other drug , following locally applicable prescribing information
Patient received prior treatment with DAC inhibitors including panobinostat
Patient has impaired cardiac function, or a prolonged QTc interval at screening ECG
Patient taking medications with relative risk of prolonging the QT interval or inducing Torsade de pointes
Female patient who is pregnant or breast feeding or with childbearing potential and not willing to use a double method of contraception up to 3 months after the end of study treatment. Male patient who is not willing to use a barrier method of contraception up to 3 months after the end of study treatment.

Other protocol-defined inclusion/exclusion criteria may apply.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Panobinostat + Bortezomib + Dexamethasone

Placebo + Bortezomib + Dexamethasone

Arm Description

Outcomes

Primary Outcome Measures

Progression-free Survival Events in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Progression Free Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Secondary Outcome Measures

Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone

Number of OS events

Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone

survival time in months

Overall Response Rate in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Best overall response based on mEBMT criteria per investigator assessment

Time to Response Per Investigator Assessment (mEBMT Criteria) of Response Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Duration of Response Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Time to Progression/Relapse Per Investigator Assessment (mEBMT Criteria) Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group

Higher values in the disease symptoms and side effects of treatment scores indicate worsening. Higher scores in the future perspective and body image scores indicate improvement. LS Means and SEM are estimated from the repeated measures model. Following factors and covariates are included in the repeated measurement model: time, treatment, treatment by time interaction, number of prior lines of anti-MM therapy (1/ 2 and 3), prior use of BTZ (Yes/ No), baseline score.Disease Symptom is the sum of 20 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome)", All subscales of EORTC QLQ-MY20 have the same score range of 0 -100. Decrease in symptom scores from baseline indicate improvement in symptoms.

European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group

The EORTC QLQ-C30 measures functional dimensions (physical, role, emotional, cognitive, and social), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), six single-item symptom scales (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale. Disease Symptom is the sum of 30 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome)", All subscales of EORTC QLQ-C30 have the same score range of 0 -100. For global health status and other functional scales,an increase from baseline indicates improvement of QoL. Whereas for symptoms scales, fatigue, dyspnea, insomnia, appetite loss, constipation and diarrhea, decrease in scores from baseline indicate improvement in symptoms.

Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group

Chronic Illness Therapy (FACIT) Measurement System and focuses on four general quality of life domains for physical well being, functional well-being, social/family well-being, and emotional well-being, and includes additional items to characterize treatment-related neurotoxicity. Higher subscales/total scores represent higher QOL. In the case of the neurotoxicity subscale, lower scores correspond to higher neurotoxicity. The recall period referenced in the questionnaire is the past 7 days.Ranges for FACT-G subscales are as follows:.PWB, scale 0 -28, , NtxS scale 0-44, FACT/GOG-Ntx trial outcome index scale is 0-100 and FACT-G scale is also scaled 0-100. An increase from baseline in these scores indicate improvement.

Full Information

NCT ID

NCT01023308

First Posted

November 30, 2009

Last Updated

March 8, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01023308

Brief Title

Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma

Acronym

PANORAMA-1

Official Title

A Multicenter, Randomized, Double Blind, Placebo Controlled Phase III Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

December 21, 2009 (Actual)

Primary Completion Date

July 30, 2015 (Actual)

Study Completion Date

July 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded protein aggregates and triggers myeloma cell death. Combination of pan-DAC and protease inhibition by co-treatment with panobinostat (PAN) and bortezomib (BTZ) has demonstrated synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. Furthermore, clinical experience in advanced multiple myeloma (MM) patients treated by oral panobinostat and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and manageable toxicity profile. Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this prospective, multinational, randomized, double-blind, placebo-controlled, parallel group Phase III study is to compare the results in progression-free survival of 2 combination therapies, panobinostat with bortezomib and dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously treated MM whose disease has recurred or progressed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

Myeloma, DACi, Bortezomib, Combination, Panobinostat, LBH589D, relapsed, Velcade®, Combination,

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

767 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Panobinostat + Bortezomib + Dexamethasone

Arm Type

Experimental

Arm Title

Placebo + Bortezomib + Dexamethasone

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Panobinostat

Other Intervention Name(s)

LBH589

Intervention Description

Panobinostat was administered 3x week ( 2 weeks on 1 week off)

Intervention Type

Drug

Intervention Name(s)

Bortezomib

Other Intervention Name(s)

(Velcade®)

Intervention Description

Bortezomib was administered 2 x week ( 2weeks on 1 week off)

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo was administered 3x week ( 2 weeks on 1 week off)

Primary Outcome Measure Information:

Title

Time Frame

45 months

Title

Progression Free Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Time Frame

45 months

Secondary Outcome Measure Information:

Title

Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone

Description

Number of OS events

Time Frame

45 months

Title

Overall Survival in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone

Description

survival time in months

Time Frame

45 months

Title

Overall Response Rate in Patients Treated With Panobinostat in Combination With Bortezomib and Dexamethasone vs. Patients Treated by Placebo in Combination With Bortezomib and Dexamethasone.

Description

Best overall response based on mEBMT criteria per investigator assessment

Time Frame

45 months

Title

Time Frame

45 months

Title

Time Frame

45 months

Title

Time Frame

45 months

Title

European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group

Description

Time Frame

12, 24 and 48 weeks

Title

European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics by Treatment Group

Description

Time Frame

12, 24 and 48 weeks

Title

Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-Change From Baseline by Treatment Group

Description

Time Frame

12, 24 and 48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient has a previous diagnosis of multiple myeloma. Patient requires retreatment for multiple myeloma Patient has measurable M component in serum or urine at study screening Exclusion Criteria: Patient who has progressed under all prior lines of anti MM therapy Patient who has been treated by bortezomib before, and did not reach at least a minor response under this therapy, or progressed under it or within 60 days of last dose Patient has shown intolerance to bortezomib or to dexamethasone or components of these drugs or has any contraindication to one or the other drug , following locally applicable prescribing information Patient received prior treatment with DAC inhibitors including panobinostat Patient has impaired cardiac function, or a prolonged QTc interval at screening ECG Patient taking medications with relative risk of prolonging the QT interval or inducing Torsade de pointes Female patient who is pregnant or breast feeding or with childbearing potential and not willing to use a double method of contraception up to 3 months after the end of study treatment. Male patient who is not willing to use a barrier method of contraception up to 3 months after the end of study treatment. Other protocol-defined inclusion/exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Phoenix

State/Province

Arizona

Country

United States

Facility Name

Novartis Investigative Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Novartis Investigative Site

City

Concord

State/Province

California

ZIP/Postal Code

94520

Country

United States

Facility Name

Novartis Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

Facility Name

Novartis Investigative Site

City

San Diego

State/Province

California

ZIP/Postal Code

92120

Country

United States

Facility Name

Novartis Investigative Site

City

Stanford

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

Novartis Investigative Site

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

Novartis Investigative Site

City

Lake Worth

State/Province

Florida

ZIP/Postal Code

33467

Country

United States

Facility Name

Novartis Investigative Site

City

Miami Shores

State/Province

Florida

ZIP/Postal Code

33138

Country

United States

Facility Name

Novartis Investigative Site

City

Athens

State/Province

Georgia

ZIP/Postal Code

30607

Country

United States

Facility Name

Novartis Investigative Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Novartis Investigative Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Novartis Investigative Site

City

Marywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Facility Name

Novartis Investigative Site

City

Quincy

State/Province

Illinois

ZIP/Postal Code

62301

Country

United States

Facility Name

Novartis Investigative Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70115

Country

United States

Facility Name

Novartis Investigative Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21229

Country

United States

Facility Name

Novartis Investigative Site

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Novartis Investigative Site

City

Southfield

State/Province

Michigan

Country

United States

Facility Name

Novartis Investigative Site

City

Edina

State/Province

Minnesota

ZIP/Postal Code

55435

Country

United States

Facility Name

Novartis Investigative Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

Facility Name

Novartis Investigative Site

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65201

Country

United States

Facility Name

Novartis Investigative Site

City

East Orange

State/Province

New Jersey

ZIP/Postal Code

07018-1095

Country

United States

Facility Name

Novartis Investigative Site

City

Mount Kisco

State/Province

New York

ZIP/Postal Code

10549

Country

United States

Facility Name

Novartis Investigative Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Novartis Investigative Site

City

Bismarck

State/Province

North Dakota

ZIP/Postal Code

58501

Country

United States

Facility Name

Novartis Investigative Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45429

Country

United States

Facility Name

Novartis Investigative Site

City

Middletown

State/Province

Ohio

ZIP/Postal Code

45042

Country

United States

Facility Name

Novartis Investigative Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

Facility Name

Novartis Investigative Site

City

East Providence

State/Province

Rhode Island

ZIP/Postal Code

02915

Country

United States

Facility Name

Novartis Investigative Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Novartis Investigative Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Novartis Investigative Site

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79106

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Novartis Investigative Site

City

Kennewick

State/Province

Washington

ZIP/Postal Code

99336

Country

United States

Facility Name

Novartis Investigative Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Novartis Investigative Site

City

Walla Walla

State/Province

Washington

ZIP/Postal Code

33962

Country

United States

Facility Name

Novartis Investigative Site

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

Facility Name

Novartis Investigative Site

City

La Plata

State/Province

Buenos Aires

ZIP/Postal Code

B1900AWT

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1114AAN

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5000JHQ

Country

Argentina

Facility Name

Novartis Investigative Site

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Novartis Investigative Site

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Novartis Investigative Site

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Novartis Investigative Site

City

Franston

State/Province

Victoria

ZIP/Postal Code

3199

Country

Australia

Facility Name

Novartis Investigative Site

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Novartis Investigative Site

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6000

Country

Australia

Facility Name

Novartis Investigative Site

City

Linz

ZIP/Postal Code

A-4010

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

A-1090

Country

Austria

Facility Name

Novartis Investigative Site

City

Jette

State/Province

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Novartis Investigative Site

City

Brasilia

State/Province

ZIP/Postal Code

70710-904

Country

Brazil

Facility Name

Novartis Investigative Site

City

Rio de Janeiro

State/Province

ZIP/Postal Code

20.211-030

Country

Brazil

Facility Name

Novartis Investigative Site

City

Rio de Janeiro

State/Province

ZIP/Postal Code

20551-030

Country

Brazil

Facility Name

Novartis Investigative Site

City

Rio de Janeiro

State/Province

ZIP/Postal Code

22640-102

Country

Brazil

Facility Name

Novartis Investigative Site

City

Barretos

State/Province

ZIP/Postal Code

14784 400

Country

Brazil

Facility Name

Novartis Investigative Site

City

Campinas

State/Province

ZIP/Postal Code

13083-970

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

ZIP/Postal Code

05403 000

Country

Brazil

Facility Name

Novartis Investigative Site

City

São Paulo

State/Province

ZIP/Postal Code

01224-000

Country

Brazil

Facility Name

Novartis Investigative Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 1V7

Country

Canada

Facility Name

Novartis Investigative Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 5C2

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Novartis Investigative Site

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V 2H1

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

Novartis Investigative Site

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

Novartis Investigative Site

City

Nanning

State/Province

Guangxi

ZIP/Postal Code

530021

Country

China

Facility Name

Novartis Investigative Site

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210029

Country

China

Facility Name

Novartis Investigative Site

City

Suzhou

State/Province

Jiangsu

ZIP/Postal Code

215006

Country

China

Facility Name

Novartis Investigative Site

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Facility Name

Novartis Investigative Site

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300020

Country

China

Facility Name

Novartis Investigative Site

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310003

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100020

Country

China

Facility Name

Novartis Investigative Site

City

Beijing

ZIP/Postal Code

100044

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200003

Country

China

Facility Name

Novartis Investigative Site

City

Shanghai

ZIP/Postal Code

200025

Country

China

Facility Name

Novartis Investigative Site

City

Brno Bohunice

State/Province

Czech Republic

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Prague 2

State/Province

Czech Republic

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Novartis Investigative Site

City

Olomouc

State/Province

CZE

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

Novartis Investigative Site

City

Copenhagen

ZIP/Postal Code

DK-2100

Country

Denmark

Facility Name

Novartis Investigative Site

City

Odense

ZIP/Postal Code

DK 5000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Vejle

ZIP/Postal Code

DK-7100

Country

Denmark

Facility Name

Novartis Investigative Site

City

Ålborg

ZIP/Postal Code

DK-9100

Country

Denmark

Facility Name

Novartis Investigative Site

City

Århus

ZIP/Postal Code

DK-8000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Alexandria

ZIP/Postal Code

21131

Country

Egypt

Facility Name

Novartis Investigative Site

City

Giza

ZIP/Postal Code

11451

Country

Egypt

Facility Name

Novartis Investigative Site

City

HUS Helsinki

ZIP/Postal Code

FIN-00029

Country

Finland

Facility Name

Novartis Investigative Site

City

Turku

ZIP/Postal Code

FIN-20521

Country

Finland

Facility Name

Novartis Investigative Site

City

Blois Cedex

ZIP/Postal Code

41016

Country

France

Facility Name

Novartis Investigative Site

City

Dijon

ZIP/Postal Code

21034

Country

France

Facility Name

Novartis Investigative Site

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Novartis Investigative Site

City

Limoges cedex

ZIP/Postal Code

87042

Country

France

Facility Name

Novartis Investigative Site

City

Nantes

ZIP/Postal Code

44035

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75231

Country

France

Facility Name

Novartis Investigative Site

City

Pierre Benite

ZIP/Postal Code

69310

Country

France

Facility Name

Novartis Investigative Site

City

Strasbourg cedex

ZIP/Postal Code

67085

Country

France

Facility Name

Novartis Investigative Site

City

Vandoeuvre Les Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

Novartis Investigative Site

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Saarow

ZIP/Postal Code

15526

Country

Germany

Facility Name

Novartis Investigative Site

City

Bamberg

ZIP/Postal Code

96049

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Bremen

ZIP/Postal Code

28177

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Duisburg

ZIP/Postal Code

47166

Country

Germany

Facility Name

Novartis Investigative Site

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22763

Country

Germany

Facility Name

Novartis Investigative Site

City

Jena

ZIP/Postal Code

07740

Country

Germany

Facility Name

Novartis Investigative Site

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Novartis Investigative Site

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81737

Country

Germany

Facility Name

Novartis Investigative Site

City

Rostock

ZIP/Postal Code

18057

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Novartis Investigative Site

City

Wuerzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

570 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

115 28

Country

Greece

Facility Name

Novartis Investigative Site

City

Hong Kong SAR

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

Hong Kong

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

New Territories

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Novartis Investigative Site

City

Kfar Saba

ZIP/Postal Code

4428164

Country

Israel

Facility Name

Novartis Investigative Site

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Novartis Investigative Site

City

Ramat Gan

ZIP/Postal Code

5265601

Country

Israel

Facility Name

Novartis Investigative Site

City

San Giovanni Rotondo

State/Province

ZIP/Postal Code

71013

Country

Italy

Facility Name

Novartis Investigative Site

City

Lecce

State/Province

ZIP/Postal Code

73100

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20133

Country

Italy

Facility Name

Novartis Investigative Site

City

Pescara

State/Province

ZIP/Postal Code

65124

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

State/Province

ZIP/Postal Code

56126

Country

Italy

Facility Name

Novartis Investigative Site

City

Pavia

State/Province

ZIP/Postal Code

27100

Country

Italy

Facility Name

Novartis Investigative Site

City

Reggio Calabria

State/Province

ZIP/Postal Code

89124

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00144

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00161

Country

Italy

Facility Name

Novartis Investigative Site

City

Pagani

State/Province

ZIP/Postal Code

84016

Country

Italy

Facility Name

Novartis Investigative Site

City

Verona

State/Province

ZIP/Postal Code

37134

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Novartis Investigative Site

City

Nagoya-city

State/Province

Aichi

ZIP/Postal Code

467-8602

Country

Japan

Facility Name

Novartis Investigative Site

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

460-0001

Country

Japan

Facility Name

Novartis Investigative Site

City

Matsuyama-city

State/Province

Ehime

ZIP/Postal Code

790-8524

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka city

State/Province

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

Facility Name

Novartis Investigative Site

City

Ogaki-city

State/Province

Gifu

ZIP/Postal Code

503-8502

Country

Japan

Facility Name

Novartis Investigative Site

City

Shibukawa

State/Province

Gunma

ZIP/Postal Code

377-8511

Country

Japan

Facility Name

Novartis Investigative Site

City

Kure-city

State/Province

Hiroshima

ZIP/Postal Code

737-0023

Country

Japan

Facility Name

Novartis Investigative Site

City

Higashiibaraki-gun

State/Province

Ibaraki

ZIP/Postal Code

311-3193

Country

Japan

Facility Name

Novartis Investigative Site

City

Okayama city

State/Province

Okayama

ZIP/Postal Code

701-1192

Country

Japan

Facility Name

Novartis Investigative Site

City

Suita city

State/Province

Osaka

ZIP/Postal Code

565 0871

Country

Japan

Facility Name

Novartis Investigative Site

City

Shibuya

State/Province

Tokyo

ZIP/Postal Code

150-8935

Country

Japan

Facility Name

Novartis Investigative Site

City

Hiroshima

ZIP/Postal Code

734-8551

Country

Japan

Facility Name

Novartis Investigative Site

City

Niigata

ZIP/Postal Code

951-8566

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

Novartis Investigative Site

City

Suwon si

State/Province

Gyeonggi Do

ZIP/Postal Code

16499

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Seocho Gu

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Busan

ZIP/Postal Code

49201

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Busan

ZIP/Postal Code

602739

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Incheon

ZIP/Postal Code

405 760

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Jeollanam-do

ZIP/Postal Code

519763

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Taegu

ZIP/Postal Code

41944

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Beirut

ZIP/Postal Code

6301

Country

Lebanon

Facility Name

Novartis Investigative Site

City

San Luis Potosí

ZIP/Postal Code

78218

Country

Mexico

Facility Name

Novartis Investigative Site

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Rotterdam

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Bergen

ZIP/Postal Code

NO-5021

Country

Norway

Facility Name

Novartis Investigative Site

City

Fredrikstad

ZIP/Postal Code

NO-1603

Country

Norway

Facility Name

Novartis Investigative Site

City

Kristiansand

ZIP/Postal Code

NO-4605

Country

Norway

Facility Name

Novartis Investigative Site

City

Oslo

ZIP/Postal Code

0407

Country

Norway

Facility Name

Novartis Investigative Site

City

Skien

ZIP/Postal Code

NO-3710

Country

Norway

Facility Name

Novartis Investigative Site

City

Trondheim

ZIP/Postal Code

7006

Country

Norway

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02 776

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-097

Country

Poland

Facility Name

Novartis Investigative Site

City

Saratov

ZIP/Postal Code

410028

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

191024

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Singapore

ZIP/Postal Code

169608

Country

Singapore

Facility Name

Novartis Investigative Site

City

Parktown

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Novartis Investigative Site

City

Pretoria

ZIP/Postal Code

0027

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cordoba

State/Province

Andalucia

ZIP/Postal Code

14004

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41013

Country

Spain

Facility Name

Novartis Investigative Site

City

Salamanca

State/Province

Castilla Y Leon

ZIP/Postal Code

37007

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46026

Country

Spain

Facility Name

Novartis Investigative Site

City

Santiago de Compostela

State/Province

Galicia

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novartis Investigative Site

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Facility Name

Novartis Investigative Site

City

San Sebastian

State/Province

Pais Vasco

ZIP/Postal Code

20080

Country

Spain

Facility Name

Novartis Investigative Site

City

La Laguna

State/Province

Santa Cruz De Tenerife

ZIP/Postal Code

38320

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Novartis Investigative Site

City

Göteborg

ZIP/Postal Code

SE-413 45

Country

Sweden

Facility Name

Novartis Investigative Site

City

Linköping

ZIP/Postal Code

SE-581 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Luleå

ZIP/Postal Code

SE-971 80

Country

Sweden

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

SE-118 83

Country

Sweden

Facility Name

Novartis Investigative Site

City

Uppsala

ZIP/Postal Code

SE-751 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Kaohsiung City

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10048

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Novartis Investigative Site

City

Istanbul

State/Province

TUR

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Novartis Investigative Site

City

Adana

ZIP/Postal Code

01330

Country

Turkey

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Aberdeen

State/Province

Scotland

ZIP/Postal Code

AB25 2ZN

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Glasgow

State/Province

Scotland

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

W12 0HS

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

WC1E 6HX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Wolverhampton

ZIP/Postal Code

WV10 0QP

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

27677481

Citation

San-Miguel JF, Einsele H, Moreau P. The Role of Panobinostat Plus Bortezomib and Dexamethasone in Treating Relapsed or Relapsed and Refractory Multiple Myeloma: A European Perspective. Adv Ther. 2016 Nov;33(11):1896-1920. doi: 10.1007/s12325-016-0413-7. Epub 2016 Sep 27.

Results Reference

derived

PubMed Identifier

27751707

Citation

San-Miguel JF, Hungria VT, Yoon SS, Beksac M, Dimopoulos MA, Elghandour A, Jedrzejczak WW, Gunther A, Nakorn TN, Siritanaratkul N, Schlossman RL, Hou J, Moreau P, Lonial S, Lee JH, Einsele H, Sopala M, Bengoudifa BR, Binlich F, Richardson PG. Overall survival of patients with relapsed multiple myeloma treated with panobinostat or placebo plus bortezomib and dexamethasone (the PANORAMA 1 trial): a randomised, placebo-controlled, phase 3 trial. Lancet Haematol. 2016 Nov;3(11):e506-e515. doi: 10.1016/S2352-3026(16)30147-8. Epub 2016 Oct 14.

Results Reference

derived

PubMed Identifier

26631116

Citation

Richardson PG, Hungria VT, Yoon SS, Beksac M, Dimopoulos MA, Elghandour A, Jedrzejczak WW, Guenther A, Nakorn TN, Siritanaratkul N, Schlossman RL, Hou J, Moreau P, Lonial S, Lee JH, Einsele H, Sopala M, Bengoudifa BR, Corrado C, Binlich F, San-Miguel JF. Panobinostat plus bortezomib and dexamethasone in previously treated multiple myeloma: outcomes by prior treatment. Blood. 2016 Feb 11;127(6):713-21. doi: 10.1182/blood-2015-09-665018. Epub 2015 Dec 2. Erratum In: Blood. 2016 Jun 30;127(26):3460.

Results Reference

derived

PubMed Identifier

25242045

Citation

San-Miguel JF, Hungria VT, Yoon SS, Beksac M, Dimopoulos MA, Elghandour A, Jedrzejczak WW, Gunther A, Nakorn TN, Siritanaratkul N, Corradini P, Chuncharunee S, Lee JJ, Schlossman RL, Shelekhova T, Yong K, Tan D, Numbenjapon T, Cavenagh JD, Hou J, LeBlanc R, Nahi H, Qiu L, Salwender H, Pulini S, Moreau P, Warzocha K, White D, Blade J, Chen W, de la Rubia J, Gimsing P, Lonial S, Kaufman JL, Ocio EM, Veskovski L, Sohn SK, Wang MC, Lee JH, Einsele H, Sopala M, Corrado C, Bengoudifa BR, Binlich F, Richardson PG. Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: a multicentre, randomised, double-blind phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1195-206. doi: 10.1016/S1470-2045(14)70440-1. Epub 2014 Sep 18. Erratum In: Lancet Oncol. 2015 Jan;16(1):e6.

Results Reference

derived

Links:

URL

http://NovartisClinicalTrials.com

Description

Related Info

Learn more about this trial

Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma

We'll reach out to this number within 24 hrs

Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma (PANORAMA-1)

Multiple Myeloma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial