A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
This study is ongoing, but not recruiting participants.
Sponsor:
Celgene Corporation
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00424047
First received: January 17, 2007
Last updated: September 19, 2012
Last verified: September 2012
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Purpose
To compare the efficacy of oral CC-5013 in combination with oral pulse high-dose dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for subjects with relapsed or refractory multiple myeloma."
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: CC-5013 plus dexamethasone Drug: Dexamethasone plus Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Official Title is A Multi-center, Randomized, Parallel-group, Double-blind, Placebo Controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma. |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Lenalidomide
U.S. FDA Resources
Further study details as provided by Celgene Corporation:
Primary Outcome Measures:
- Time to tumor progression (TTP) [ Time Frame: Up to 23 months ] [ Designated as safety issue: No ]Time from randomization to the first documentation of progressive disease based on the Myeloma response determination criteria developed by Bladé et al 1998
Secondary Outcome Measures:
- Number of patients who survived [ Time Frame: Up to 23 months ] [ Designated as safety issue: Yes ]Time from randomization to death from any cause
- Number of participants with adverse events [ Time Frame: Up to 23 months ] [ Designated as safety issue: Yes ]Number of participants with adverse events
- Myeloma response rate [ Time Frame: Up to 23 months ] [ Designated as safety issue: No ]Myeloma response determination criteria developed by Bladé et al 1998
- Time to first symptomatic skeletal-related event (SRE) (clinical need for radiation or surgery to bone) [ Time Frame: Up to 23 months ] [ Designated as safety issue: No ]Time for randomization to the date of the first occurred of a symptomatic SRE (clinical need for radiotherapy or surgery to bone)
- Time to first worsening on the Eastern Cooperative Oncology Group (ECOG) performance scale [ Time Frame: Up to 23 months ] [ Designated as safety issue: No ]Time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization
| Estimated Enrollment: | 351 |
| Study Start Date: | January 2003 |
| Estimated Study Completion Date: | December 2013 |
| Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CC-5013 plus dexamethasone
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.
|
Drug: CC-5013 plus dexamethasone
25 mg daily for 21 days every 28 days.
Other Names:
|
|
Experimental: Dexamethasone plus placebo
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.
|
Drug: Dexamethasone plus Placebo
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.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424047
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Hide Study LocationsLocations
| Australia, New South Wales | |
| Royal Prince Alfred Hospital | |
| Camperdown, New South Wales, Australia, 2050 | |
| Australia, Victoria | |
| Peter MacCallum Cancer Centre Divsion of Haematology/Medical Oncology | |
| East Melbourne, Victoria, Australia, 3006 | |
| The Alfred Hospital | |
| Prahran, Victoria, Australia, 3121 | |
| Border Medical Oncology | |
| Wodonga, Victoria, Australia, 3690 | |
| Australia | |
| Box Hill Hospital | |
| Box Hill, Australia, VIC 3128 | |
| Frankston Hospital Oncology Research | |
| Frankston, Australia, VIC 3199 | |
| Royal Brisbane Hospital | |
| Herston, Australia, QLD4029 | |
| The Royal Melbourne Hospital | |
| Parkville, Australia, 3050 | |
| Mater Public Hospital | |
| South Brisbane, Australia, QLD 4101 | |
| Austria | |
| University Hospital of Salzburg St Johanns Spital | |
| Salzburg, Austria, A -5020 | |
| Wilhelminenspital | |
| Vienna, Austria, 1160 | |
| Belgium | |
| CHU Saint-Luc | |
| Brussel, Belgium, 1200 | |
| UZ Gasthuisberg | |
| Leuven, Belgium, 3000 | |
| France | |
| Centre Hospitalier Lyon Sud | |
| Chemin Grand Revoyet, France, 69495 Pierre Benite cedex | |
| Hopital Claude Huriez | |
| Lille, France, 59037 | |
| Centre Hospitalier Hotel-Dieu | |
| Nantes, France | |
| Hopital Saint-Loius | |
| Paris, France, 75010 | |
| Chu de Bordeaux Groupe Hospitalier Sud | |
| Pessac, France, 33640 | |
| CHU Purpan | |
| Toulouse cedex 9, France, TSA 40031-31059 | |
| CHU Nancy - Hopital Brabois | |
| Vandoeuvre, France, 54511 | |
| Germany | |
| Universitatsklinik ChariteMedizinische Fakultaet der HumboldtUniversitaet zu Berlin | |
| Berlin, Germany, 13353 | |
| Universitaetsklinikum Charite | |
| Berlin, Germany, 13125 | |
| Universitaetsklinikum Dusseldorf Klinik fuer Haematologie | |
| Dusseldorf, Germany, 40225 | |
| Universitaetsklinkum Erlangen | |
| Erlangen, Germany, 91054 | |
| Klininkum der Johann-Wolfgang-Goethe-Universtat | |
| Frankfurt am Main, Germany, 60590 | |
| Universitaetsklinikum Heidelberg Medizinische Klinik und Poliklinik V | |
| Heidelberg, Germany, 69120 | |
| Universitatsklinik Muenster Medizinische Klinik A | |
| Muenster, Germany, 48129 | |
| Klinikum der Univeristact Muenchen | |
| Munchen, Germany, 80336 | |
| Universitaetsklinikum Tuebingen | |
| Tubingen, Germany, 72076 | |
| Greece | |
| "Alexandras" General Hospital of Athens | |
| Athens, Greece, 11538 | |
| Ireland | |
| University Hospital GalwayHaematology Department | |
| Galway, Co. Galway, Ireland | |
| Belfast City HospitalHaematology Department | |
| Belfast, Ireland, BT9 7AB | |
| Hope Directorate Haematology Oncology Service St. James Hospital | |
| Dublin 8, Ireland | |
| MidWestern Regional Hospital | |
| Limerick, Ireland | |
| Israel | |
| Rambam Medical Center | |
| Haifa, Israel, 31096 | |
| Hadassah University Hospital | |
| Jerusalem, Israel | |
| Tel Aviv Sourasky Medical Center Department of Hematology | |
| Tel Aviv, Israel, 64239 | |
| The Chaim Sheba Medical Center | |
| Tel Hashomer, Israel, 52621 | |
| Italy | |
| Policlinico Sant'Orsola-Malpighi | |
| Bologna, Italy, 40138 | |
| Azienda Ospedaliera San Martino | |
| Genova, Italy, 16132 | |
| Ospedale Niguarda Ca Granda | |
| Milano, Italy, 20162 | |
| Policlinico San Matteo | |
| Pavia, Italy, 27100 | |
| Univerita La Sapien | |
| Roma, Italy, 00161 | |
| Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista | |
| Torio, Italy, 10126 | |
| Policlinico Universitario a Gesttione diretta di Udine | |
| Udine, Italy, 33100 | |
| Poland | |
| Institute of Internal Diseases University of Medicine | |
| Gdansk, Poland, 80-211 | |
| University School of Medicine | |
| Lublin, Poland, 20-290 | |
| Institute of Haematology and Blood Transfusion | |
| Warsaw, Poland, 00-957 | |
| Spain | |
| Hospital Clinic | |
| Barcelona, Spain, 08036 | |
| Hospital Doce de Octubre | |
| Madrid, Spain, 28041 | |
| Hospital Universitario de la Princessa | |
| Madrid, Spain, 28006 | |
| Clinica Universitaria de Navarra | |
| Pamplona, Spain, 31080 | |
| Hospital Universitario de Salamanca | |
| Salamanca, Spain, 37007 | |
| Hospital Universtario Marques de Valdecilla | |
| Santander, Spain, 39008 | |
| Sweden | |
| Sahlgrenska University Hospital Department of Hematology and Coagulation | |
| Goteborg, Sweden, S-413 45 | |
| Switzerland | |
| Centre Hospitalier Universitaire Vaudois (CHUV) | |
| Lausanne, Switzerland, 1011 | |
| Kantonsspital St. Gallen | |
| St. Gallen, Switzerland | |
| Universitätsspital Zürich | |
| Zürich, Switzerland, 8091 | |
| Ukraine | |
| Cherkassy Regional Oncology Center | |
| Cherkassy, Ukraine, 18009 | |
| Dnepropetrovsk City Clinical Hospital #4 | |
| Dnepropetrovsk, Ukraine, 49044 | |
| Kiev Bone Marrow Transplantation Center Bone Marrow Department | |
| Kiev, Ukraine, 03115 | |
| Institute of Hematology and Transfusiology of the UAMS Department of blood diseases | |
| Kiev, Ukraine, 04060 | |
| Institute of Blood Pathology and Transfusion Medicine of the UAMS | |
| Lviv, Ukraine, 79044 | |
| Institute of Blood Pathology and Transfusion Medicine of the UAMS Hematology Department | |
| Lvov, Ukraine, 79044 | |
| Odess Regional Clinical Hospital | |
| Odessa, Ukraine, 65025 | |
| Zhitomir Regional Clinical Hospital | |
| Zhitomir, Ukraine, 10003 | |
| United Kingdom | |
| University College Hospital Trust | |
| London, Bloomsbury, United Kingdom, WC1E 6AU | |
| Bristol Haematology and Oncology Centre | |
| Bristol, United Kingdom, BS2 8ED | |
| Haematology Dept, 4th Floor Thomas Guy House | |
| London, United Kingdom, SE1 9RT | |
Sponsors and Collaborators
Celgene Corporation
Investigators
| Study Director: | Robert Knight, MD | Celgene Corporation |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00424047 History of Changes |
| Other Study ID Numbers: | CC-5013-MM-010 |
| Study First Received: | January 17, 2007 |
| Last Updated: | September 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Celgene Corporation:
|
Multiple Myeloma Celgene Revlimid CC-5013 |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Dexamethasone acetate |
Dexamethasone Dexamethasone 21-phosphate Lenalidomide BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones |
ClinicalTrials.gov processed this record on May 22, 2013