| April 4, 2003 |
| September 22, 2009 |
| February 2003 |
| April 2006 (final data collection date for primary outcome measure) |
| Compare the efficacy of combination thalidomide and dexamethasone treatments [ Time Frame: Years ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00057564 on ClinicalTrials.gov Archive Site |
| |
| |
| |
| Study of Combination Thalidomide Plus Glucocorticoid Therapy Versus Glucocorticoid Therapy Alone as Induction Therapy for Previously Untreated Subjects With Multiple Myeloma |
| A Multicenter Parallel-Group, Placebo Controlled, Randomized, Double-Blind Study of Combination Thalidomide Plus Glucocorticoid Therapy Versus Glucocorticoid Therapy Alone as Induction Therapy for Previously Untreated Subjects With Multiple Myeloma |
Randomized subjects will receive study drug, either thalidomide plus high-dose dexamethasone or placebo identical in appearance to thalidomide plus high-dose dexamethasone, in 4-week cycles. Subjects will remain on study drug until they experience disease progression or until the subject discontinues for any other reason. Subjects will have visits every cycle and all subjects will be followed for survival even after discontinuation from study drug. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Multiple Myeloma |
- Drug: Thalidomide and Dexamethasone
- Drug: Dexamethasone
|
- Active Comparator: Thalidomide & Dexamethasone
- Placebo Comparator: Dexamethasone and placebo
|
| Rajkumar SV, Rosiñol L, Hussein M, Catalano J, Jedrzejczak W, Lucy L, Olesnyckyj M, Yu Z, Knight R, Zeldis JB, Bladé J. Multicenter, randomized, double-blind, placebo-controlled study of thalidomide plus dexamethasone compared with dexamethasone as initial therapy for newly diagnosed multiple myeloma. J Clin Oncol. 2008 May 1;26(13):2171-7. Epub 2008 Mar 24. |
| |
| Active, not recruiting |
| 470 |
| December 2011 |
| April 2006 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Active Multiple Myeloma Stage II or III Durie Salmon
- Measurable levels of myeloma paraprotein in serum or urine
- ECOG performance status of 0, 1, 2
- Women of child bearing potential must agree to abstain for heterosexual intercourse or use 2 methods of contraception, one effective(for example hormonal or tubal ligation) and one barrier(for example latex condom, diaphragm)
- Males must agree to use barrier contraception (latex condoms) when engaging in reproductive activity
Exclusion Criteria:
- Pregnant or lactating females
- Peripheral neuropathy greater than or equal to grade 2 of the NCI CTC.
- Prior history of malignancy unless subject has been free of disease for greater than or equal to 5 years
- Lab abnormality: Absolute neutrophil count less than 1,000 cells/mm cubed
- Lab abnormality: Platelet count less than 50,000 mm cubed
- Lab abnormality: Serum creatinine greater than 3.0 mg/dL
- Lab abnormality: Serum SGOT/AST or SGPT/ALT greater than 3 times the upper limit
- Lab abnormality: Serum total bilirubin greater than 2.0 mg/dL.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Australia, Belgium, Bulgaria, Canada, Germany, Hungary, Ireland, Israel, Italy, Poland, Russian Federation, Spain, Switzerland, Ukraine, United Kingdom |
| |
| NCT00057564 |
| Robert Knight MD, VP Oncology/Hematology, Celgene Corporation |
| THAL-MM-003 |
| Celgene Corporation |
|
| Study Director: |
Robert Knight, MD |
Celgene Corporation |
|
|
| Celgene Corporation |
| September 2009 |
