AzTrials
AzTrials

Multiple MyelomaPhase 3PANORAMA-1NCT01023308

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

A Phase 3 study testing Panobinostat, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Novartis Pharmaceuticals at 210 sites in 34 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Panobinostat, Bortezomib and Dexamethasone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
767 participants
Where
210 sitesin 34 countries
Study dates
21 Dec 2009to 30 Jul 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

210 sites in 34 countries.

210 sites in 34 countries

United States38 sites

  • Novartis Investigative Site

    Amarillo, Texas, 79106

  • Novartis Investigative Site

    Anaheim, California, 92801

  • Novartis Investigative Site

    Athens, Georgia, 30607

  • Novartis Investigative Site

    Atlanta, Georgia, 30322

  • Novartis Investigative Site

    Baltimore, Maryland, 21229

  • Novartis Investigative Site

    Bismarck, North Dakota, 58501

  • Novartis Investigative Site

    Boca Raton, Florida, 33486

  • Novartis Investigative Site

    Boston, Massachusetts, 02215

  • Novartis Investigative Site

    Columbia, Missouri, 65201

  • Novartis Investigative Site

    Concord, California, 94520

  • Novartis Investigative Site

    Dayton, Ohio, 45429

  • Novartis Investigative Site

    Durham, North Carolina, 27710

  • Novartis Investigative Site

    East Orange, New Jersey, 07018-1095

  • Novartis Investigative Site

    East Providence, Rhode Island, 02915

  • Novartis Investigative Site

    Edina, Minnesota, 55435

  • Novartis Investigative Site

    Houston, Texas, 77030

  • Novartis Investigative Site

    Kennewick, Washington, 99336

  • Novartis Investigative Site

    Lake Worth, Florida, 33467

  • Novartis Investigative Site

    Los Angeles, California, 90027

  • Novartis Investigative Site

    Marietta, Georgia, 30060

  • Novartis Investigative Site

    Marywood, Illinois, 60153

  • Novartis Investigative Site

    Miami Shores, Florida, 33138

  • Novartis Investigative Site

    Middletown, Ohio, 45042

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55404

  • Novartis Investigative Site

    Morgantown, West Virginia, 26506

  • Novartis Investigative Site

    Mount Kisco, New York, 10549

  • Novartis Investigative Site

    Nashville, Tennessee, 37203

  • Novartis Investigative Site

    Nashville, Tennessee, 37232

  • Novartis Investigative Site

    New Orleans, Louisiana, 70115

  • Novartis Investigative Site

    Phoenix, Arizona

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania, 15224

  • Novartis Investigative Site

    Quincy, Illinois, 62301

  • Novartis Investigative Site

    Rockville, Maryland, 20850

  • Novartis Investigative Site

    San Diego, California, 92120

  • Novartis Investigative Site

    Seattle, Washington, 98104

  • Novartis Investigative Site

    Southfield, Michigan

  • Novartis Investigative Site

    Stanford, California, 94304

  • Novartis Investigative Site

    Walla Walla, Washington, 33962

Other trials in United States

Germany17 sites

  • Novartis Investigative Site

    Aachen, 52074

  • Novartis Investigative Site

    Bad Saarow, 15526

  • Novartis Investigative Site

    Bamberg, 96049

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Bremen, 28177

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Duisburg, 47166

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Frankfurt, 60590

  • Novartis Investigative Site

    Hamburg, 22763

  • Novartis Investigative Site

    Jena, 07740

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Magdeburg, 39120

  • Novartis Investigative Site

    München, 81737

  • Novartis Investigative Site

    Rostock, 18057

  • Novartis Investigative Site

    Ulm, 89081

  • Novartis Investigative Site

    Würzburg, 97080

Other trials in Germany

Japan14 sites

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 812-8582

  • Novartis Investigative Site

    Higashiibaraki-gun, Ibaraki, 311-3193

  • Novartis Investigative Site

    Hiroshima, 734-8551

  • Novartis Investigative Site

    Kure, Hiroshima, 737-0023

  • Novartis Investigative Site

    Matsuyama, Ehime, 790-8524

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 460-0001

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 467-8602

  • Novartis Investigative Site

    Niigata, 951-8566

  • Novartis Investigative Site

    Ōgaki, Gifu, 503-8502

  • Novartis Investigative Site

    Okayama, Okayama-ken, 701-1192

  • Novartis Investigative Site

    Osaka, 545-8586

  • Novartis Investigative Site

    Shibukawa, Gunma, 377-8511

  • Novartis Investigative Site

    Shibuya City, Tokyo, 150-8935

  • Novartis Investigative Site

    Suita, Osaka, 565 0871

Other trials in Japan

Italy12 sites

  • Novartis Investigative Site

    Lecce, LE, 73100

  • Novartis Investigative Site

    Milan, MI, 20133

  • Novartis Investigative Site

    Naples, 80131

  • Novartis Investigative Site

    Pagani, SA, 84016

  • Novartis Investigative Site

    Pavia, PV, 27100

  • Novartis Investigative Site

    Pescara, PE, 65124

  • Novartis Investigative Site

    Pisa, PI, 56126

  • Novartis Investigative Site

    Reggio Calabria, RC, 89124

  • Novartis Investigative Site

    Roma, RM, 00144

  • Novartis Investigative Site

    Roma, RM, 00161

  • Novartis Investigative Site

    San Giovanni Rotondo, FG, 71013

  • Novartis Investigative Site

    Verona, VR, 37134

Other trials in Italy

China11 sites

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100730

  • Novartis Investigative Site

    Beijing, 100020

  • Novartis Investigative Site

    Beijing, 100044

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310003

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210029

  • Novartis Investigative Site

    Nanning, Guangxi, 530021

  • Novartis Investigative Site

    Shanghai, 200003

  • Novartis Investigative Site

    Shanghai, 200025

  • Novartis Investigative Site

    Suzhou, Jiangsu, 215006

  • Novartis Investigative Site

    Tianjin, Tianjin Municipality, 300020

Other trials in China

South Korea10 sites

  • Novartis Investigative Site

    Busan, 49201

  • Novartis Investigative Site

    Busan, 602739

  • Novartis Investigative Site

    Incheon, 405 760

  • Novartis Investigative Site

    Jeollanam-do, Jeollanam-do, 519763

  • Novartis Investigative Site

    Seoul, Seocho Gu, 06591

  • Novartis Investigative Site

    Seoul, 03080

  • Novartis Investigative Site

    Seoul, 03722

  • Novartis Investigative Site

    Seoul, 06351

  • Novartis Investigative Site

    Suwon, Gyeonggi-do, 16499

  • Novartis Investigative Site

    Taegu, 41944

Other trials in South Korea

Spain10 sites

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036

  • Novartis Investigative Site

    Barcelona, 08041

  • Novartis Investigative Site

    Córdoba, Andalusia, 14004

  • Novartis Investigative Site

    Donostia / San Sebastian, Basque Country, 20080

  • Novartis Investigative Site

    Pamplona, Navarre, 31008

  • Novartis Investigative Site

    Salamanca, Castille and León, 37007

  • Novartis Investigative Site

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

  • Novartis Investigative Site

    Santiago de Compostela, Galicia, 15706

  • Novartis Investigative Site

    Seville, Andalusia, 41013

  • Novartis Investigative Site

    Valencia, Valencia, 46026

Other trials in Spain

France9 sites

  • Novartis Investigative Site

    Blois, 41016

  • Novartis Investigative Site

    Dijon, 21034

  • Novartis Investigative Site

    Lille, 59037

  • Novartis Investigative Site

    Limoges, 87042

  • Novartis Investigative Site

    Nantes, 44035

  • Novartis Investigative Site

    Paris, 75231

  • Novartis Investigative Site

    Pierre-Bénite, 69310

  • Novartis Investigative Site

    Strasbourg, 67085

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Brazil8 sites

  • Novartis Investigative Site

    Barretos, São Paulo, 14784 400

  • Novartis Investigative Site

    Brasília, Federal District, 70710-904

  • Novartis Investigative Site

    Campinas, São Paulo, 13083-970

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 20.211-030

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 20551-030

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 22640-102

  • Novartis Investigative Site

    São Paulo, São Paulo, 01224-000

  • Novartis Investigative Site

    São Paulo, São Paulo, 05403 000

Other trials in Brazil

United Kingdom8 sites

  • Novartis Investigative Site

    Aberdeen, Scotland, AB25 2ZN

  • Novartis Investigative Site

    Glasgow, Scotland, G12 0YN

  • Novartis Investigative Site

    London, EC1A 7BE

  • Novartis Investigative Site

    London, SE5 9RS

  • Novartis Investigative Site

    London, W12 0HS

  • Novartis Investigative Site

    London, WC1E 6HX

  • Novartis Investigative Site

    Manchester, M20 4BX

  • Novartis Investigative Site

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Australia6 sites

  • Novartis Investigative Site

    Franston, Victoria, 3199

  • Novartis Investigative Site

    Herston, Queensland, 4029

  • Novartis Investigative Site

    Nedlands, Western Australia, 6009

  • Novartis Investigative Site

    Perth, Western Australia, 6000

  • Novartis Investigative Site

    St Leonards, New South Wales, 2065

  • Novartis Investigative Site

    Woolloongabba, Queensland, 4102

Other trials in Australia

Norway6 sites

  • Novartis Investigative Site

    Bergen, NO-5021

  • Novartis Investigative Site

    Fredrikstad, NO-1603

  • Novartis Investigative Site

    Kristiansand, NO-4605

  • Novartis Investigative Site

    Oslo, 0407

  • Novartis Investigative Site

    Skien, NO-3710

  • Novartis Investigative Site

    Trondheim, 7006

Other trials in Norway

Canada5 sites

  • Novartis Investigative Site

    Greenfield Park, Quebec, J4V 2H1

  • Novartis Investigative Site

    Halifax, Nova Scotia, B3H 1V7

  • Novartis Investigative Site

    Hamilton, Ontario, L8V 5C2

  • Novartis Investigative Site

    Montreal, Quebec, H1T 2M4

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Denmark5 sites

  • Novartis Investigative Site

    Aalborg, DK-9100

  • Novartis Investigative Site

    Aarhus, DK-8000

  • Novartis Investigative Site

    Copenhagen, DK-2100

  • Novartis Investigative Site

    Odense, DK 5000

  • Novartis Investigative Site

    Vejle, DK-7100

Other trials in Denmark

Sweden5 sites

  • Novartis Investigative Site

    Gothenburg, SE-413 45

  • Novartis Investigative Site

    Linköping, SE-581 85

  • Novartis Investigative Site

    Luleå, SE-971 80

  • Novartis Investigative Site

    Stockholm, SE-118 83

  • Novartis Investigative Site

    Uppsala, SE-751 85

Other trials in Sweden

Israel4 sites

  • Novartis Investigative Site

    Jerusalem, 91120

  • Novartis Investigative Site

    Kfar Saba, 4428164

  • Novartis Investigative Site

    Petah Tikva, 49100

  • Novartis Investigative Site

    Ramat Gan, 5265601

Other trials in Israel

Taiwan4 sites

  • Novartis Investigative Site

    Kaohsiung City, 83301

  • Novartis Investigative Site

    Taichung, 40447

  • Novartis Investigative Site

    Taipei, 10048

  • Novartis Investigative Site

    Taoyuan, 333

Other trials in Taiwan

Argentina3 sites

  • Novartis Investigative Site

    Buenos Aires, C1114AAN

  • Novartis Investigative Site

    Córdoba, X5000JHQ

  • Novartis Investigative Site

    La Plata, Buenos Aires, B1900AWT

Other trials in Argentina

Belgium3 sites

  • Novartis Investigative Site

    Brussels, 1200

  • Novartis Investigative Site

    Hasselt, 3500

  • Novartis Investigative Site

    Jette, Brussels Capital, 1090

Other trials in Belgium

Czechia3 sites

  • Novartis Investigative Site

    Brno-Bohunice, Czech Republic, 625 00

  • Novartis Investigative Site

    Olomouc, CZE, 775 20

  • Novartis Investigative Site

    Prague, Czech Republic, 128 08

Other trials in Czechia

Hong Kong3 sites

  • Novartis Investigative Site

    Hong Kong

  • Novartis Investigative Site

    Hong Kong SAR

  • Novartis Investigative Site

    New Territories, Hong Kong

Other trials in Hong Kong

Netherlands3 sites

  • Novartis Investigative Site

    Rotterdam, 3015 CE

  • Novartis Investigative Site

    Rotterdam

  • Novartis Investigative Site

    Utrecht, 3584 CX

Other trials in Netherlands

Thailand3 sites

  • Novartis Investigative Site

    Bangkok, 10330

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Bangkok, 10700

Other trials in Thailand

Turkey (Türkiye)3 sites

  • Novartis Investigative Site

    Adana, 01330

  • Novartis Investigative Site

    Ankara, 06100

  • Novartis Investigative Site

    Istanbul, TUR, 34098

Other trials in Turkey (Türkiye)

Austria2 sites

  • Novartis Investigative Site

    Linz, A-4010

  • Novartis Investigative Site

    Vienna, A-1090

Other trials in Austria

Egypt2 sites

  • Novartis Investigative Site

    Alexandria, 21131

  • Novartis Investigative Site

    Giza, 11451

Other trials in Egypt

Finland2 sites

  • Novartis Investigative Site

    HUS Helsinki, FIN-00029

  • Novartis Investigative Site

    Turku, FIN-20521

Other trials in Finland

Greece2 sites

  • Novartis Investigative Site

    Athens, 115 28

  • Novartis Investigative Site

    Thessaloniki, GR, 570 10

Other trials in Greece

Poland2 sites

  • Novartis Investigative Site

    Warsaw, 02 776

  • Novartis Investigative Site

    Warsaw, 02-097

Other trials in Poland

Russia2 sites

  • Novartis Investigative Site

    Saint Petersburg, 191024

  • Novartis Investigative Site

    Saratov, 410028

Other trials in Russia

South Africa2 sites

  • Novartis Investigative Site

    Parktown, 2193

  • Novartis Investigative Site

    Pretoria, 0027

Other trials in South Africa

Lebanon1 site

  • Novartis Investigative Site

    Beirut, 6301

Other trials in Lebanon

Mexico1 site

  • Novartis Investigative Site

    San Luis Potosí City, 78218

Other trials in Mexico

Singapore1 site

  • Novartis Investigative Site

    Singapore, 169608

Other trials in Singapore

About this study

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

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.

Being tested
Panobinostat, Bortezomib, Dexamethasone, Placebo
Keywords
Myeloma, DACi, Bortezomib, Combination, Panobinostat, LBH589D, relapsed, Velcade®, Combination,
Medical subject headings
Multiple Myeloma, Neoplasms, Plasma Cell, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PanobinostatDrug

    Also called LBH589

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

  • BortezomibDrug

    Also called (Velcade®)

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

  • DexamethasoneDrug

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

  • PlaceboDrug

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

Study groups in NCT01023308
Study groupRoleWhat they receive
Panobinostat + Bortezomib + DexamethasoneExperimentalNot described
Receives: Drug: Panobinostat; Drug: Bortezomib; Drug: Dexamethasone
Placebo + Bortezomib + DexamethasonePlacebo comparatorNot described
Receives: Drug: Bortezomib; Drug: Dexamethasone; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 45 months

  2. 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.

    Measured: 45 months

Secondary outcomes (9)

  1. 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

    Measured: 45 months

  2. 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

    Measured: 45 months

  3. 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

    Measured: 45 months

  4. 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.

    Measured: 45 months

  5. 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.

    Measured: 45 months

  6. 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.

    Measured: 45 months

  7. 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.

    Measured: 12, 24 and 48 weeks

  8. 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.

    Measured: 12, 24 and 48 weeks

  9. 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.

    Measured: 12, 24 and 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2009 (estimated)
  2. Study start21 Dec 2009
  3. Primary completion30 Jul 2015
  4. Study completion30 Jul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
767 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01023308
Sponsor's protocol ID
CLBH589D2308
Other IDs
2009-015507-52, 2009
Acronym
PANORAMA-1
Status last verified
Mar 2020
First submitted
30 Nov 2009
Last updated
17 Mar 2020

Publications

  • 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.

    PubMed 27751707

  • 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.

    PubMed 27677481

  • 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.

    PubMed 26631116

  • 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.

    PubMed 25242045

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Panobinostat, Bortezomib and Dexamethasone in people with Multiple Myeloma, run by Novartis Pharmaceuticals at 210 sites in 34 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 210 sites in United States, Germany, Japan, Italy, China and 29 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 45 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01023308, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.

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