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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

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


Inclusion Criteria:



1. Patient has a previous diagnosis of multiple myeloma.

2. Patient requires retreatment for multiple myeloma

3. Patient has measurable M component in serum or urine at study screening

Exclusion Criteria:

1. Patient who has progressed under all prior lines of anti MM therapy

2. 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

3. 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

4. Patient received prior treatment with DAC inhibitors including panobinostat

5. Patient has impaired cardiac function, or a prolonged QTc interval at screening ECG

6. Patient taking medications with relative risk of prolonging the QT interval or
inducing Torsade de pointes

7. 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

To compare 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.

Outcome Time Frame:

30 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLBH589D2308

NCT ID:

NCT01023308

Start Date:

December 2009

Completion Date:

March 2014

Related Keywords:

  • Multiple Myeloma
  • Myeloma
  • DACi
  • Bortezomib
  • Combination,
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Duke University Medical Center Durham, North Carolina  27710
Dana Farber Cancer Institute Boston, Massachusetts  02115
Kaiser Permanente Sacramento, California  
Dayton CCOP Dayton, Ohio  45429
Associates in Oncology/Hematology, P.C. Kensington, Maryland  20895
Sarah Cannon Research Institute Nashville, Tennessee  37203
Emory University School of Medicine/Winship Cancer Institute Atlanta, Georgia  30322
Northeast Georgia Cancer Care Athens, Georgia  30607
Bay Area Cancer Research Concord, California  94520
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center New Orleans, Louisiana  70115
Quincy Medical Group Quincy, Illinois  62301
Hubert H. Humphrey Cancer Center - Coon Rapids Coon Rapids, Minnesota  55433
Pharma Resource East Providence, Rhode Island  02915
Medical Specialist of Palm Beaches Lake Worth, Florida  33467
Loyola University Chicago Maywood, Illinois  60153
Western Pennsylvania Cancer Institute /Western Penn Hospital Western Pann. Cancer Inst. Pittsburgh, Pennsylvania  15224
West Virginia University/ Mary Babb Randolph Cancer Center Morgantown, West Virginia  26506
Legacy Pharma Research Bismarck, North Dakota  58501
Missouri Cancer Associates Dept.ofMissouriCancerAssoc. Columbia, Missouri  65201
Cancer Center of the High Plains Amarillo, Texas  79106
Arizona Oncology Associates Tucson (Carondelet & Wilmot) Phoenix, Arizona  
Rau, Subramanyam Anaheim, California  92801
Southern California Permanente Medical Group SC Los Angeles, California  90027
Stanford University Medical Center School of Medicine Stanford, California  94304
Innovative Medical Research of South Florida Dept.ofInnovativeMedResearch Miami Shores, Florida  33138
NorthWest Georgia Oncology Centers NW Georgia Oncology Centers PC Marietta, Georgia  30060
St. Agnes Hospital Healthcare Cancer Center Baltimore, Maryland  21229
Newland Medical Associates, PC Newland Medical - Southfield Southfield, Michigan  
Minnesota Oncology Hematology, P.A. Minnesota Oncology Hematology, Minneapolis, Minnesota  55404
East Orange VA Medical Center SC East Orange, New Jersey  07018-1095
Mount Kisco Medical Group Mt. Kisco, New York  10549
Signal Point Hematology Oncology, Inc. Middletown, Ohio  45042
Vanderbilt Univeristy SC Nashville, Tennessee  37232
MD Anderson Cancer Center/University of Texas MD Anderson CC Houston, Texas  77030
Columbia Basin Hematology SC Kennewick, Washington  99336
Swedish Cancer Institute SC Seattle, Washington  98104
St. Mary Medical Center Walla Walla, Washington  33962
Kaiser Permanente - California Southern Kaiser Permanente SCPMG San Diego, California  
Boca Raton Community Hospital SC Boca Raton, Florida  33486