A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Celgene, Revlimid, CC-5013
Eligibility Criteria
Inclusion Criteria:
- Prior or current diagnosis Durie-Salmon stage II or III multiple myeloma.
- Measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0,1, or 2
- Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug
Exclusion Criteria:
- Prior development of disease progression during high-dose dexamethasone containing therapy
- Pregnant or lactating females
- The development of a desquamating rash while taking thalidomide
- Use of any standard/experimental anti-myeloma therapy within 28 days of randomization or use of any experimental non-drug therapy within 56 days of initiation of drug treatment
- Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm3
- Laboratory abnormalities: Platelet count < 75,000/mm3
- Laboratory abnormalities: Serum creatinine > 2.5 mg/dL
- Laboratory abnormalities: Serum Serum glutamic oxaloacetic transaminase (SGOT)/Aspartate aminotransferase (AST) or Serum glutamic pyruvic transaminase (SGPT)/Alanine aminotransferase (ALT) > 3.0 x upper limit of normal
- Laboratory abnormalities: Serum total bilirubin > 2.0 mg/dL
- Prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for ≥ 3 years.
Sites / Locations
- Royal Prince Alfred Hospital
- Peter MacCallum Cancer Centre Divsion of Haematology/Medical Oncology
- The Alfred Hospital
- Border Medical Oncology
- Box Hill Hospital
- Frankston Hospital Oncology Research
- Royal Brisbane Hospital
- The Royal Melbourne Hospital
- Mater Public Hospital
- University Hospital of Salzburg St Johanns Spital
- Wilhelminenspital
- CHU Saint-Luc
- UZ Gasthuisberg
- Centre Hospitalier Lyon Sud
- Hopital Claude Huriez
- Centre Hospitalier Hotel-Dieu
- Hopital Saint-Loius
- Chu de Bordeaux Groupe Hospitalier Sud
- CHU Purpan
- CHU Nancy - Hopital Brabois
- Universitaetsklinikum Charite
- Universitatsklinik ChariteMedizinische Fakultaet der HumboldtUniversitaet zu Berlin
- Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
- Universitaetsklinkum Erlangen
- Klininkum der Johann-Wolfgang-Goethe-Universtat
- Universitaetsklinikum Heidelberg Medizinische Klinik und Poliklinik V
- Universitatsklinik Muenster Medizinische Klinik A
- Klinikum der Univeristact Muenchen
- Universitaetsklinikum Tuebingen
- "Alexandras" General Hospital of Athens
- University Hospital GalwayHaematology Department
- Belfast City HospitalHaematology Department
- Hope Directorate Haematology Oncology Service St. James Hospital
- MidWestern Regional Hospital
- Rambam Medical Center
- Hadassah University Hospital
- Tel Aviv Sourasky Medical Center Department of Hematology
- The Chaim Sheba Medical Center
- Policlinico Sant'Orsola-Malpighi
- Azienda Ospedaliera San Martino
- Ospedale Niguarda Ca Granda
- Policlinico San Matteo
- Univerita La Sapien
- Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
- Policlinico Universitario a Gesttione diretta di Udine
- Institute of Internal Diseases University of Medicine
- University School of Medicine
- Institute of Haematology and Blood Transfusion
- Hospital Clinic
- Hospital Universitario de la Princessa
- Hospital Doce de Octubre
- Clinica Universitaria de Navarra
- Hospital Universitario de Salamanca
- Hospital Universtario Marques de Valdecilla
- Sahlgrenska University Hospital Department of Hematology and Coagulation
- Centre Hospitalier Universitaire Vaudois (CHUV)
- Kantonsspital St. Gallen
- Universitätsspital Zürich
- Cherkassy Regional Oncology Center
- Dnepropetrovsk City Clinical Hospital #4
- Kiev Bone Marrow Transplantation Center Bone Marrow Department
- Institute of Hematology and Transfusiology of the UAMS Department of blood diseases
- Institute of Blood Pathology and Transfusion Medicine of the UAMS
- Institute of Blood Pathology and Transfusion Medicine of the UAMS Hematology Department
- Odess Regional Clinical Hospital
- Zhitomir Regional Clinical Hospital
- University College Hospital Trust
- Bristol Haematology and Oncology Centre
- Haematology Dept, 4th Floor Thomas Guy House
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
CC-5013 plus dexamethasone
Dexamethasone plus placebo
Arm A: Oral CC-5013 is initiated on Day 1 of Cycle 1 at a dose of 25 mg daily for 21 days every 28 days. Therefore, the subject will take a placebo identical in appearance to the CC-5013 capsule for week 4 of every 28 days. Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral CC-5013 placebo capsules will be administered for 28 days of every cycle.
Arm B: Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral placebo capsules will be administered for 28 days of every cycle.