Multiple MyelomaPhase 3NCT00056160
CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
A Phase 3 study testing CC-5013 and Dexamethasone in people with Multiple Myeloma, run by Celgene at 49 sites in 2 countries.
Trial summary
Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase. 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 and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 49 sitesin 2 countries
- Study dates
- 1 Jan 2003to 1 Oct 2008
- 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.
- No more than 3 previous anti-myeloma regimens
- No high-dose dexamethasone (total monthly dose of dexamethasone greater than 200 mg) within 6 months of study randomization.
- Measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample).
Who cannot join
- Prior development of disease progression during high-dose dexamethasone containing therapy.
- Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm cubed
- Laboratory abnormalities: Platelet count less than 75,000/mm cubed
- Laboratory abnormalities: Serum creatinine greater than 2.5 mg/dL
- Laboratory abnormalities: Serum glutamic oxaloacetic transaminase (SGOT, aspartate transaminase [AST]) or serum glutamic pyruvic transaminase (SGPT, alanine transaminase [ALT])greater than 3.0 x upper limit of normal
- Laboratory abnormalities: Serum total bilirubin greater than 2.0 mg/dL
Show all 9Show fewer
- Prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for greater than or equal to 5 years.
- Known hypersensitivity to thalidomide or dexamethasone.
- Development of a desquamating rash while taking thalidomide.
Trial locations and contacts
49 sites in 2 countries.
49 sites in 2 countries
United States44 sites
University Of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
Medical College of Georgia
Augusta, Georgia, 30912-3125
Johns Hopkins Medicine Department of Oncology
Baltimore, Maryland, 21231
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Roswell Park Cancer Institute
Buffalo, New York, 14263
Charleston Hematology/Oncology P.A.
Charleston, South Carolina, 29403
Medical University of SC
Charleston, South Carolina, 29425
Northwestern University Med Ctr
Chicago, Illinois, 60611-2927
Rush Cancer Institute Section of Hematology
Chicago, Illinois, 60612-3824
Cleveland Clinic Myeloma Program
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
Karmanos Cancer Institute
Detroit, Michigan, 48201
City of Hope National Medical Center
Duarte, California, 91010
Duke University Medical Center
Durham, North Carolina, 27710
University of Florida
Gainesville, Florida, 32610
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Clinical Research Consultants, Inc.
Hoover, Alabama, 35216
MD Anderson Cancer Center
Houston, Texas, 77030-4009
Indiana Cancer Research Institute
Indianapolis, Indiana, 46202-5254
University of Iowa Hospital Clinic
Iowa City, Iowa, 52242
Mayo Clinic- Jacksonville
Jacksonville, Florida, 32224
UCLA School of Medicine
Los Angeles, California, 90095
Loyola University Medical Center
Maywood, Illinois, 60153
University of Miami
Miami, Florida, 33136
Froedtert Hospital/BMT Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3522
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203-1632
Yale University School of Medicine
New Haven, Connecticut, 06520
Ocshner Clinical Foundation
New Orleans, Louisiana, 70121
St. Vincent's Comprehensive Cancer Center
New York, New York, 10011
New York Presbyterian Hospital
New York, New York, 10021
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Kaiser Permanente Northwest Region Center for Health Research
Portland, Oregon, 97227
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
UCSF California
San Francisco, California, 94143
Oncology Hematology Consultants
Sarasota, Florida, 34239
Washington University School of Medicine- Sherman Cancer Center
St Louis, Missouri, 63110
Stanford University Medical Center, Division of Hematology
Stanford, California, 94305-5112
SUNY Upstate Medical University
Syracuse, New York, 13210
H Lee Moffitt Cancer Center
Tampa, Florida, 33612-9497
MBCCOP Our Lady of Mercy Cancer Center New York Medical College
The Bronx, New York, 10466
South Carolina Oncology Group
West Columbia, South Carolina, 29169
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157-1023
Canada5 sites
Cross Cancer Institute
Edmonton, Alberta, T6G1Z2
Hospital Charles LeMoyne
Greenfield Park, Quebec, J4V2H1
Dalhousie University
Halifax, Nova Scotia, B3H2Y9
McGill University
Montreal, Quebec, PQH2W1S6
Princess Margaret Hospital
Toronto, Ontario, M5J2M9
About this study
Official title: A Multicenter, Randomized, Parallel-Group, Double-blind, Placebo-controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.
Read the detailed description
This was a phase 3, multicenter, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of CC-5013 plus oral pulse high-dose dexamethasone and oral pulse high-dose dexamethasone therapy alone in subjects with relapsed or refractory multiple myeloma. Eligible subjects were randomized in a 1:1 ratio to 1 of 2 treatment groups: Subjects in the CC-5013/Dex treatment group took 25 mg of CC-5013 orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle; Subjects in the Placebo/Dex treatment group took 1 placebo capsule on Days 1 to 28 of each 28-day cycle. Subjects in both treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.
- Conditions
- Multiple Myeloma
- Being tested
- CC-5013, Dexamethasone
- Keywords
- Multiple Myeloma, Refractory and Relapsed, Revlimid, CC5013
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-5013Drug
Also called lenalidomide, Revlimid
Subjects in the CC-5013/Dex treatment group took 25 mg of lenalidomide orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle.
DexamethasoneDrug
Also called Decadron
Subjects in the CC-5013/Dex and Placebo/Dex treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.
| Study group | Role | What they receive |
|---|---|---|
| CC-5013/Dex | Experimental | CC-5013 (lenalidomide) plus oral high-dose dexamethasone Receives: Drug: CC-5013; Drug: Dexamethasone |
| Placebo/Dex | Experimental | Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Tumor Progression (TTP)
Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123.
Measured: 60 weeks (median Time To Progression of CC-5013/Dex treatment group)
Secondary outcomes (3)
Overall Survival
Overall survival was calculated as the time from randomization to death from any cause.
Measured: 170 weeks (median overall survival of CC-5013/Dex treatment group)
Myeloma Response
The overall confirmed response that was maintained for ≥6 weeks. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.
Measured: Up to Unblinding (07 Jun 2005)
Time to First Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (Best Score=0, Fully Active, Able to Carry on All Pre-disease Performance Without Restriction; Worst Score=5, Dead.)
The time to first worsening on the ECOG Performance Scale was calculated as the time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization.
Measured: 30 weeks (mean time to first worsening of ECOG performance status for CC-5013/Dex treatment group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2003 (estimated)
- Study start1 Jan 2003
- Primary completion1 Nov 2005
- Study completion1 Oct 2008
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
- 353 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
- NCT00056160
- Sponsor's protocol ID
- CC-5013-MM-009
- Status last verified
- Sep 2017
- First submitted
- 6 Mar 2003
- Last updated
- 19 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, Siegel D, Borrello I, Rajkumar SV, Chanan-Khan AA, Lonial S, Yu Z, Patin J, Olesnyckyj M, Zeldis JB, Knight RD; Multiple Myeloma (009) Study Investigators. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007 Nov 22;357(21):2133-42. doi: 10.1056/NEJMoa070596.
PubMed 18032763San-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
- A Multicenter, 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
- NCT00056160
- Acronym / sponsor ID
- CC-5013-MM-009
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Refractory and Relapsed, Revlimid, CC5013
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2003 (actual)
- Primary completion
- 1 Nov 2005 (actual)
- Study completion
- 1 Oct 2008 (actual)
- First posted
- 7 Mar 2003 (estimated)
- Results
- Posted 3 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.
Detailed description
This was a phase 3, multicenter, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of CC-5013 plus oral pulse high-dose dexamethasone and oral pulse high-dose dexamethasone therapy alone in subjects with relapsed or refractory multiple myeloma. Eligible subjects were randomized in a 1:1 ratio to 1 of 2 treatment groups: Subjects in the CC-5013/Dex treatment group took 25 mg of CC-5013 orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle; Subjects in the Placebo/Dex treatment group took 1 placebo capsule on Days 1 to 28 of each 28-day cycle. Subjects in both treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.
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/Dex | Experimental | Drug: CC-5013, Drug: DexamethasoneCC-5013 (lenalidomide) plus oral high-dose dexamethasone |
| Placebo/Dex | Experimental | Drug: DexamethasonePlacebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone |
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.
- No more than 3 previous anti-myeloma regimens
- No high-dose dexamethasone (total monthly dose of dexamethasone greater than 200 mg) within 6 months of study randomization.
- Measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample).
Key exclusion criteria (9 listed)
- Prior development of disease progression during high-dose dexamethasone containing therapy.
- Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm cubed
- Laboratory abnormalities: Platelet count less than 75,000/mm cubed
- Laboratory abnormalities: Serum creatinine greater than 2.5 mg/dL
- Laboratory abnormalities: Serum glutamic oxaloacetic transaminase (SGOT, aspartate transaminase [AST]) or serum glutamic pyruvic transaminase (SGPT, alanine transaminase [ALT])greater than 3.0 x upper limit of normal
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-5013Also: lenalidomide, RevlimidSubjects in the CC-5013/Dex treatment group took 25 mg of lenalidomide orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle. | Drug | CC-5013/Dex |
| DexamethasoneAlso: DecadronSubjects in the CC-5013/Dex and Placebo/Dex treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles. | Drug | CC-5013/Dex, Placebo/Dex |
Primary outcome
Time to Tumor Progression (TTP)
Time frame: 60 weeks (median Time To Progression of CC-5013/Dex treatment group)
Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123.
3 secondary outcomes
Overall Survival
Time frame: 170 weeks (median overall survival of CC-5013/Dex treatment group)
Myeloma Response
Time frame: Up to Unblinding (07 Jun 2005)
Time to First Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (Best Score=0, Fully Active, Able to Carry on All Pre-disease Performance Without Restriction; Worst Score=5, Dead.)
Time frame: 30 weeks (mean time to first worsening of ECOG performance status for CC-5013/Dex treatment group)
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 18032763Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, Siegel D, Borrello I, Rajkumar SV, Chanan-Khan AA, Lonial S, Yu Z, Patin J, Olesnyckyj M, Zeldis JB, Knight RD; Multiple Myeloma (009) Study Investigators. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007 Nov 22;357(21):2133-42. doi: 10.1056/NEJMoa070596.
- 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
49 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CC-5013 and Dexamethasone in people with Multiple Myeloma, run by Celgene at 49 sites in 2 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 9 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 49 sites in United States, Canada. 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 3 Mar 2010). 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?
Time to Tumor Progression (TTP) (time frame: 60 weeks (median Time To Progression of CC-5013/Dex treatment group)). 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 NCT00056160, 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.