Multiple Myeloma Clinical Trial

Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma

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.

View Eligibility Criteria

Eligibility 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

Exclusion Criteria:

primary refractory myeloma
refractory to bortezomib
concomitant anti-cancer therapy (other than 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.

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

249

Study ID:

NCT02654990

Recruitment Status:

Completed

Sponsor:

pharmaand GmbH

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There are 78 Locations for this study

See Locations Near You

Novartis Investigative Site
Fayetteville Arkansas, 72703, United States
Novartis Investigative Site
Los Angeles California, 90017, United States
Novartis Investigative Site
Fort Collins Colorado, 80528, United States
Novartis Investigative Site
Gainesville Florida, 32608, United States
Novartis Investigative Site
Atlanta Georgia, 30322, United States
Novartis Investigative Site
Louisville Kentucky, 40202, United States
Novartis Investigative Site
Boston Massachusetts, 02215, United States
Novartis Investigative Site
Lake Success New York, 11042, United States
Novartis Investigative Site
Morgantown West Virginia, 26506, United States
Novartis Investigative Site
Prahran Victoria, 3181, Australia
Novartis Investigative Site
Hasselt , 3500, Belgium
Novartis Investigative Site
Barretos Sao Paulo, 14784, Brazil
Novartis Investigative Site
Sao Paulo SP, 04537, Brazil
Novartis Investigative Site
Sao Paulo , 05403, Brazil
Novartis Investigative Site
Edmonton Alberta, T6G 1, Canada
Novartis Investigative Site
Kitchener Ontario, N2G 1, Canada
Novartis Investigative Site
Ostrava Poruba Czech Republic, 708 5, Czechia
Novartis Investigative Site
Praha , 12808, Czechia
Novartis Investigative Site
Bayonne Bayonne Cedex, 64109, France
Novartis Investigative Site
Avignon Cedex 9 , 84902, France
Novartis Investigative Site
Grenoble , 38043, France
Novartis Investigative Site
La Roche sur Yon Cedex , 85295, France
Novartis Investigative Site
Lille , 59037, France
Novartis Investigative Site
Metz , 57000, France
Novartis Investigative Site
Nantes Cedex 1 , 44093, France
Novartis Investigative Site
Paris , 75231, France
Novartis Investigative Site
Pessac , 33604, France
Novartis Investigative Site
Bad Saarow , 15526, Germany
Novartis Investigative Site
Bayreuth , 95445, Germany
Novartis Investigative Site
Darmstadt , 64287, Germany
Novartis Investigative Site
Dresden , 01307, Germany
Novartis Investigative Site
Halle Saale , 06120, Germany
Novartis Investigative Site
Hamburg , 22763, Germany
Novartis Investigative Site
Kiel , 24105, Germany
Novartis Investigative Site
Leipzig , 04103, Germany
Novartis Investigative Site
Athens , 115 2, Greece
Novartis Investigative Site
Athens , 115 2, Greece
Novartis Investigative Site
Patras , 265 0, Greece
Novartis Investigative Site
Debrecen HUN, 4032, Hungary
Novartis Investigative Site
Budapest , 1097, Hungary
Novartis Investigative Site
Kaposvar , 7400, Hungary
Novartis Investigative Site
Nyiregyhaza , 4400, Hungary
Novartis Investigative Site
Roma RM, 00161, Italy
Novartis Investigative Site
Rimini RN, 47900, Italy
Novartis Investigative Site
Hwasun , 58128, Korea, Republic of
Novartis Investigative Site
Seoul , 03080, Korea, Republic of
Novartis Investigative Site
Beirut , 16683, Lebanon
Novartis Investigative Site
Beirut , , Lebanon
Novartis Investigative Site
Sidon , 652, Lebanon
VUmc, Hematology, PK2 BR012
Amsterdam , 1081 , Netherlands
Albert Schweitzer ziekenhuis, Hematology
Dordrecht , 3318 , Netherlands
Novartis Investigative Site
Oslo , NO 04, Norway
Novartis Investigative Site
Lublin , 20 09, Poland
Novartis Investigative Site
Torun , 87 10, Poland
Novartis Investigative Site
Warszawa , 02 10, Poland
Novartis Investigative Site
Warszawa , 02 77, Poland
Novartis Investigative Site
Wroclaw , 50 36, Poland
Novartis Investigative Site
Braga , 47102, Portugal
Novartis Investigative Site
Porto , 4200-, Portugal
Novartis Investigative Site
Saint Petersburg , 19102, Russian Federation
Novartis Investigative Site
Saratov , 41001, Russian Federation
Novartis Investigative Site
Malaga Andalucia, 29010, Spain
Novartis Investigative Site
Salamanca Castilla Y Leon, 37007, Spain
Novartis Investigative Site
Barcelona Catalunya, 08035, Spain
Novartis Investigative Site
Barcelona Catalunya, 08036, Spain
Novartis Investigative Site
L'Hospitalet De Llobregat Catalunya, 08907, Spain
Novartis Investigative Site
La Laguna Santa Cruz De Tenerife, 38320, Spain
Novartis Investigative Site
Madrid , 28006, Spain
Novartis Investigative Site
Madrid , 28040, Spain
Novartis Investigative Site
Madrid , 28041, Spain
Novartis Investigative Site
Zaragoza , 50009, Spain
Novartis Investigative Site
Lulea , SE 97, Sweden
Novartis Investigative Site
Lund , SE-22, Sweden
Novartis Investigative Site
Uppsala , SE-75, Sweden
Novartis Investigative Site
Mueang Nonthaburi Muang, 40002, Thailand
Novartis Investigative Site
Bangkok , 10330, Thailand
Novartis Investigative Site
Chiang Mai , 50200, Thailand
Novartis Investigative Site
Ankara , 06100, Turkey
Novartis Investigative Site
Istanbul , 34899, Turkey
Novartis Investigative Site
Izmir , 35340, Turkey

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

249

Study ID:

NCT02654990

Recruitment Status:

Completed

Sponsor:


pharmaand GmbH

How clear is this clinincal trial information?

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