Multiple MyelomaPhase 3NCT00424047
A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
A Phase 3 study testing CC-5013 plus dexamethasone in people with Multiple Myeloma, run by Celgene at 69 sites in 15 countries.
Trial summary
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." 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?
- CC-5013 plus dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 351 participants
- Where
- 69 sitesin 15 countries
- Study dates
- 1 Jan 2003to 12 Nov 2013
- 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
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
69 sites in 15 countries.
69 sites in 15 countries
Australia9 sites
Box Hill Hospital
Box Hill, VIC 3128
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Peter MacCallum Cancer Centre Divsion of Haematology/Medical Oncology
East Melbourne, Victoria, 3006
Frankston Hospital Oncology Research
Frankston, VIC 3199
Royal Brisbane Hospital
Herston, QLD4029
The Royal Melbourne Hospital
Parkville, 3050
The Alfred Hospital
Prahran, Victoria, 3121
Mater Public Hospital
South Brisbane, QLD 4101
Border Medical Oncology
Wodonga, Victoria, 3690
Germany9 sites
Universitaetsklinikum Charite
Berlin, 13125
Universitatsklinik ChariteMedizinische Fakultaet der HumboldtUniversitaet zu Berlin
Berlin, 13353
Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
Düsseldorf, 40225
Universitaetsklinkum Erlangen
Erlangen, 91054
Klininkum der Johann-Wolfgang-Goethe-Universtat
Frankfurt am Main, 60590
Universitaetsklinikum Heidelberg Medizinische Klinik und Poliklinik V
Heidelberg, 69120
Klinikum der Univeristact Muenchen
München, 80336
Universitatsklinik Muenster Medizinische Klinik A
Münster, 48129
Universitaetsklinikum Tuebingen
Tübingen, 72076
Ukraine8 sites
Cherkassy Regional Oncology Center
Cherkassy, 18009
Dnepropetrovsk City Clinical Hospital #4
Dnipro, 49044
Kiev Bone Marrow Transplantation Center Bone Marrow Department
Kiev, 03115
Institute of Hematology and Transfusiology of the UAMS Department of blood diseases
Kiev, 04060
Institute of Blood Pathology and Transfusion Medicine of the UAMS Hematology Department
Lviv, 79044
Institute of Blood Pathology and Transfusion Medicine of the UAMS
Lviv, 79044
Odess Regional Clinical Hospital
Odesa, 65025
Zhitomir Regional Clinical Hospital
Zhytomyr, 10003
France7 sites
Centre Hospitalier Lyon Sud
Chemin Grand Revoyet, 69495 Pierre Benite cedex
Hopital Claude Huriez
Lille, 59037
Centre Hospitalier Hotel-Dieu
Nantes
Hopital Saint-Loius
Paris, 75010
Chu de Bordeaux Groupe Hospitalier Sud
Pessac, 33640
CHU Purpan
Toulouse, TSA 40031-31059
CHU Nancy - Hopital Brabois
Vandœuvre-lès-Nancy, 54511
Italy7 sites
Policlinico Sant'Orsola-Malpighi
Bologna, 40138
Azienda Ospedaliera San Martino
Genova, 16132
Ospedale Niguarda Ca Granda
Milan, 20162
Policlinico San Matteo
Pavia, 27100
Univerita La Sapien
Roma, 00161
Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
Torio, 10126
Policlinico Universitario a Gesttione diretta di Udine
Udine, 33100
Spain6 sites
Hospital Clinic
Barcelona, 08036
Hospital Universitario de la Princessa
Madrid, 28006
Hospital Doce de Octubre
Madrid, 28041
Clinica Universitaria de Navarra
Pamplona, 31080
Hospital Universitario de Salamanca
Salamanca, 37007
Hospital Universtario Marques de Valdecilla
Santander, 39008
Ireland4 sites
Belfast City HospitalHaematology Department
Belfast, BT9 7AB
Hope Directorate Haematology Oncology Service St. James Hospital
Dublin
University Hospital GalwayHaematology Department
Galway, Co. Galway
MidWestern Regional Hospital
Limerick
Israel4 sites
Rambam Medical Center
Haifa, 31096
Hadassah University Hospital
Jerusalem
Tel Aviv Sourasky Medical Center Department of Hematology
Tel Aviv, 64239
The Chaim Sheba Medical Center
Tel HaShomer, 52621
Poland3 sites
Institute of Internal Diseases University of Medicine
Gdansk, 80-211
University School of Medicine
Lublin, 20-290
Institute of Haematology and Blood Transfusion
Warsaw, 00-957
Switzerland3 sites
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, 1011
Kantonsspital St. Gallen
Sankt Gallen
Universitätsspital Zürich
Zurich, 8091
United Kingdom3 sites
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED
University College Hospital Trust
London, Bloomsbury, WC1E 6AU
Haematology Dept, 4th Floor Thomas Guy House
London, SE1 9RT
Austria2 sites
University Hospital of Salzburg St Johanns Spital
Salzburg, A -5020
Wilhelminenspital
Vienna, 1160
Sweden1 site
Sahlgrenska University Hospital Department of Hematology and Coagulation
Gothenburg, S-413 45
About this study
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.
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."
- Conditions
- Multiple Myeloma
- Being tested
- CC-5013 plus dexamethasone, Dexamethasone plus Placebo
- Keywords
- Multiple Myeloma, Celgene, Revlimid, CC-5013
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-5013 plus dexamethasoneDrug
Also called Revlimid, lenalidomide
25 mg daily for 21 days every 28 days.
Dexamethasone plus PlaceboDrug
Also called Dexamethasone, 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.
| Study group | Role | What they receive |
|---|---|---|
| CC-5013 plus dexamethasone | Experimental | 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. Receives: Drug: CC-5013 plus dexamethasone |
| Dexamethasone plus placebo | Experimental | 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. Receives: Drug: Dexamethasone plus Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kaplan-Meier Estimate of Time to Tumor Progression (TTP)
Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
Measured: From randomization up to cut-off date of 03 August 2005; up to 24 months
Kaplan-Meier Estimate of Time to Tumor Progression (TTP) (Later Cut-off Date of 02 Mar 2008)
Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
Measured: From randomization up to cut-off date of 02 March 2008; up to 51 months
Secondary outcomes (8)
Kaplan-Meier Estimate of Overall Survival (OS)
OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
Measured: Randomization to data cut off of 03 August 2005; up to 24 months
Kaplan-Meier Estimate of Overall Survival (OS) (Later Cut-off Date of 02 March 2008)
OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
Measured: Randomization to data cut off of 02 March 2008; up to 51 months
Summary of Myeloma Response Rates Based on Best Response Assessment
Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.
Measured: Randomization to 03 August 2005; up to 24 months
Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008)
Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.
Measured: Randomization to data cut-off of 02 Mar 2008; up to 51 months
Number of Participants With Adverse Events (AE)
An AE is any sign, symptom, illness, or diagnosis that appears or worsens during the course of the study. Treatment-emergent AEs (TEAEs) are any AE occurring or worsening on or after the first treatment of the study drug and within 30 days after the last cycle end date of study drug. A serious AE = any AE which results in death; is life-threatening; requires or prolongs existing inpatient hospitalization; results in persistent or significant disability is a congenital anomaly/birth defect; constitutes an important medical event.
The severity of AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE, Version 2.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.
Measured: From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 25 June 2013; up to 90 months
Time to First Symptomatic Skeletal-related Event (SRE) (Clinical Need for Radiation or Surgery to Bone)
Time from randomization to the date of the first occurrence of a symptomatic SRE (clinical need for radiotherapy or surgery to bone).
Measured: Up to unblinding data cut off of 03 August 2005; up to 24 months
Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented.
Measured: Randomization to cut off date of 03 August 2005; up to 24 months
Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Later Cut-off Date of 02 March 2008)
The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented.
Measured: Randomization to cut off date of 02 March 2008; up to 51 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study start1 Jan 2003
- Primary completion1 Nov 2005
- Study completion12 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Knight, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424047
- Sponsor's protocol ID
- CC-5013-MM-010
- Status last verified
- Sep 2017
- First submitted
- 17 Jan 2007
- Last updated
- 19 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, San Miguel J, Hellmann A, Facon T, Foa R, Corso A, Masliak Z, Olesnyckyj M, Yu Z, Patin J, Zeldis JB, Knight RD; Multiple Myeloma (010) Study Investigators. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007 Nov 22;357(21):2123-32. doi: 10.1056/NEJMoa070594.
PubMed 18032762San-Miguel JF, Dimopoulos MA, Stadtmauer EA, Rajkumar SV, Siegel D, Bravo ML, Olesnyckyj M, Knight RD, Zeldis JB, Harousseau JL, Weber DM. Effects of lenalidomide and dexamethasone treatment duration on survival in patients with relapsed or refractory multiple myeloma treated with lenalidomide and dexamethasone. Clin Lymphoma Myeloma Leuk. 2011 Feb;11(1):38-43. doi: 10.3816/CLML.2010.n.120.
PubMed 21273172Zangari M, Tricot G, Polavaram L, Zhan F, Finlayson A, Knight R, Fu T, Weber D, Dimopoulos MA, Niesvizky R, Fink L. Survival effect of venous thromboembolism in patients with multiple myeloma treated with lenalidomide and high-dose dexamethasone. J Clin Oncol. 2010 Jan 1;28(1):132-5. doi: 10.1200/JCO.2009.23.0169. Epub 2009 Nov 9.
PubMed 19901114Wang M, Dimopoulos MA, Chen C, Cibeira MT, Attal M, Spencer A, Rajkumar SV, Yu Z, Olesnyckyj M, Zeldis JB, Knight RD, Weber DM. Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure. Blood. 2008 Dec 1;112(12):4445-51. doi: 10.1182/blood-2008-02-141614. Epub 2008 Sep 17.
PubMed 18799726
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00424047
- Acronym / sponsor ID
- CC-5013-MM-010
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Celgene, Revlimid, CC-5013
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2003 (actual)
- Primary completion
- 1 Nov 2005 (actual)
- Study completion
- 12 Nov 2013 (actual)
- First posted
- 18 Jan 2007 (estimated)
- Results
- Posted 4 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CC-5013 plus dexamethasone | Experimental | Drug: CC-5013 plus dexamethasoneArm 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. |
| Dexamethasone plus placebo | Experimental | Drug: Dexamethasone plus PlaceboArm 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC-5013 plus dexamethasoneAlso: Revlimid, lenalidomide25 mg daily for 21 days every 28 days. | Drug | CC-5013 plus dexamethasone |
| Dexamethasone plus PlaceboAlso: Dexamethasone, PlaceboOral 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 |
Primary outcome
Kaplan-Meier Estimate of Time to Tumor Progression (TTP)
Time frame: From randomization up to cut-off date of 03 August 2005; up to 24 months
Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
Kaplan-Meier Estimate of Time to Tumor Progression (TTP) (Later Cut-off Date of 02 Mar 2008)
Time frame: From randomization up to cut-off date of 02 March 2008; up to 51 months
Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
8 secondary outcomes
Kaplan-Meier Estimate of Overall Survival (OS)
Time frame: Randomization to data cut off of 03 August 2005; up to 24 months
Kaplan-Meier Estimate of Overall Survival (OS) (Later Cut-off Date of 02 March 2008)
Time frame: Randomization to data cut off of 02 March 2008; up to 51 months
Summary of Myeloma Response Rates Based on Best Response Assessment
Time frame: Randomization to 03 August 2005; up to 24 months
Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008)
Time frame: Randomization to data cut-off of 02 Mar 2008; up to 51 months
Number of Participants With Adverse Events (AE)
Time frame: From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 25 June 2013; up to 90 months
Time to First Symptomatic Skeletal-related Event (SRE) (Clinical Need for Radiation or Surgery to Bone)
Time frame: Up to unblinding data cut off of 03 August 2005; up to 24 months
Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Time frame: Randomization to cut off date of 03 August 2005; up to 24 months
Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Later Cut-off Date of 02 March 2008)
Time frame: Randomization to cut off date of 02 March 2008; up to 51 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18032762Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, San Miguel J, Hellmann A, Facon T, Foa R, Corso A, Masliak Z, Olesnyckyj M, Yu Z, Patin J, Zeldis JB, Knight RD; Multiple Myeloma (010) Study Investigators. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007 Nov 22;357(21):2123-32. doi: 10.1056/NEJMoa070594.
- Derived from this study: PubMed 21273172San-Miguel JF, Dimopoulos MA, Stadtmauer EA, Rajkumar SV, Siegel D, Bravo ML, Olesnyckyj M, Knight RD, Zeldis JB, Harousseau JL, Weber DM. Effects of lenalidomide and dexamethasone treatment duration on survival in patients with relapsed or refractory multiple myeloma treated with lenalidomide and dexamethasone. Clin Lymphoma Myeloma Leuk. 2011 Feb;11(1):38-43. doi: 10.3816/CLML.2010.n.120.
- Derived from this study: PubMed 19901114Zangari M, Tricot G, Polavaram L, Zhan F, Finlayson A, Knight R, Fu T, Weber D, Dimopoulos MA, Niesvizky R, Fink L. Survival effect of venous thromboembolism in patients with multiple myeloma treated with lenalidomide and high-dose dexamethasone. J Clin Oncol. 2010 Jan 1;28(1):132-5. doi: 10.1200/JCO.2009.23.0169. Epub 2009 Nov 9.
- Derived from this study: PubMed 18799726Wang M, Dimopoulos MA, Chen C, Cibeira MT, Attal M, Spencer A, Rajkumar SV, Yu Z, Olesnyckyj M, Zeldis JB, Knight RD, Weber DM. Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure. Blood. 2008 Dec 1;112(12):4445-51. doi: 10.1182/blood-2008-02-141614. Epub 2008 Sep 17.
- Link to CSR synopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Knight, MD study director
Celgene Corporation
69 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CC-5013 plus dexamethasone in people with Multiple Myeloma, run by Celgene at 69 sites in 15 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 4 inclusion and 10 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 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in Australia, Germany, Ukraine, France, Italy and 10 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. 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 4 Mar 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?
Kaplan-Meier Estimate of Time to Tumor Progression (TTP) (time frame: From randomization up to cut-off date of 03 August 2005; up to 24 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 NCT00424047, 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 19 Oct 2017.