CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
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| ClinicalTrials.gov Identifier: NCT00056160 |
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Recruitment Status :
Completed
First Posted : March 7, 2003
Results First Posted : March 3, 2010
Last Update Posted : October 19, 2017
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Sponsor:
Celgene
Information provided by (Responsible Party):
Celgene
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma | Drug: CC-5013 Drug: Dexamethasone | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 353 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | January 1, 2003 |
| Actual Primary Completion Date : | November 1, 2005 |
| Actual Study Completion Date : | October 1, 2008 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
| Arm | Intervention/treatment |
|---|---|
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Experimental: CC-5013/Dex
CC-5013 (lenalidomide) plus oral high-dose dexamethasone
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Drug: CC-5013
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.
Other Names:
Drug: Dexamethasone 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.
Other Name: Decadron |
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Experimental: Placebo/Dex
Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
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Drug: Dexamethasone
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.
Other Name: Decadron |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Overall Survival [ Time Frame: 170 weeks (median overall survival of CC-5013/Dex treatment group) ]Overall survival was calculated as the time from randomization to death from any cause.
- Myeloma Response [ Time Frame: Up to Unblinding (07 Jun 2005) ]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.
- 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) ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056160
Locations
Show 49 study locations
Sponsors and Collaborators
Celgene
Investigators
| Study Director: | Robert Knight, MD | Celgene Corporation |
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Celgene |
| ClinicalTrials.gov Identifier: | NCT00056160 |
| Other Study ID Numbers: |
CC-5013-MM-009 |
| First Posted: | March 7, 2003 Key Record Dates |
| Results First Posted: | March 3, 2010 |
| Last Update Posted: | October 19, 2017 |
| Last Verified: | September 2017 |
Keywords provided by Celgene:
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Multiple Myeloma Refractory and Relapsed Revlimid CC5013 |
Additional relevant MeSH terms:
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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 |
Lenalidomide Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Immunologic Factors Angiogenesis Inhibitors Angiogenesis Modulating Agents |