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Sponsors and Collaborators: |
Celgene Corporation Parexel |
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Information provided by: | Celgene Corporation |
ClinicalTrials.gov Identifier: | NCT00405756 |
Phase III randomised study to compare MPR with MP in newly diagnosed Multiple Myeloma subjects who are 65 years old or older.
Condition | Intervention | Phase |
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Newly Diagnosed Multiple Myeloma |
Drug: Lenalidomide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled, 3 Arm Parallel-Group Study to Determine the Efficacy and Safety of Lenalidomide (Revlimid) in Combination With Melphalan and Prednisone Versus Placebo Plus Melphalan and Prednisone in Subjects With Newly Diagnosed Multiple Myeloma Who Are 65 Years of Age or Older |
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
MM diagnostic criteria (all 3 required)
Before starting study drug:
Female Subjects:
FCBP must have two negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to starting study drug. The first pregnancy test must be performed within 10-14 days prior to the start of study drug and the second pregnancy test must be performed within 24 hours prior to the start of study drug. The subject may not receive study drug until the Investigator has verified that the results of these pregnancy tests are negative.
Male Subjects:
Must agree to use a latex condom during any sexual contact with FCBP** while participating in this study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy.
Will be warned that sharing study drug is prohibited and will be counselled about pregnancy precautions and potential risks of fetal exposure.
Must agree to abstain from donating semen or sperm during study participation and for at least 28 days after discontinuation from the study.
During study participation and for 28 days following discontinuation from the study:
All Subjects:
No more than a 28-day supply of study drug will be dispensed at a time.
Female Subjects:
FCBP with regular cycles must agree to have pregnancy tests weekly for the first 28 days of study participation and then every 28 days while on study, at study discontinuation, and at day 28 following discontinuation from the study. If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days and then every 14 days while on study, at study discontinuation, and at days 14 and 28 following discontinuation from the study.
In addition to the required pregnancy testing, the Investigator must confirm with FCBP that she is continuing to use two reliable methods of birth control at each visit. Counselling about pregnancy precautions and the potential risks of fetal exposure must be conducted at a minimum of every 28 days. During counselling, subjects must be reminded to not share study drug and to not donate blood.
Pregnancy testing and counselling must be performed if a subject misses her period or if her pregnancy test or her menstrual bleeding is abnormal. Study drug treatment must be discontinued during this evaluation.
Females must agree to abstain from breastfeeding during study participation and for at least 28 days after the discontinuation from the study.
Male Subjects:
Counselling about the requirement for latex condom use during sexual contact with females of childbearing potential and the potential risks of fetal exposure must be conducted at a minimum of every 28 days. During counselling, subjects must be reminded to not share study drug and to not donate blood, sperm, or semen.
If pregnancy or a positive pregnancy test does occur in a study subject or the partner of a study subject during study participation, study drug must be immediately discontinued.
Exclusion Criteria
Any of the following laboratory abnormalities:
Absolute neutrophil count (ANC) < 1,500 cells/mL (1.5 x 109/L) Platelet count < 75,000 cells/mL (75 x 109/L) for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; but platelet count <30,000/mL for subjects in whom ³ 50% of bone marrow nucleated cells are plasma cells Haemoglobin < 8.0 g/dL (80 g/L) Serum creatinine > 2.5 mg/dL (221 µmol/L) Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for greater than or equal to 3 years.
Exceptions include the following:
Basal cell carcinoma of the skin Squamous cell carcinoma of the skin Carcinoma in situ of the cervix Carcinoma in situ of the breast Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
Contact: Robert Knight, MD | rknight@celgene.com |
Principal Investigator: | Attonio Palumbo | Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista |
Study ID Numbers: | CC-5013-MM-015 |
Study First Received: | November 29, 2006 |
Last Updated: | January 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00405756 |
Health Authority: | Denmark: Ministry of Research, Denmark by law |
Newly Diagnosed Multiple Myeloma Celgene CC-5013 Revlimid |
Lenalidomide Melphalan Prednisone Elderly |
Melphalan Prednisone Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Lenalidomide Vascular Diseases |
Paraproteinemias Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Glucocorticoids Hormones Pharmacologic Actions Neoplasms Therapeutic Uses Cardiovascular Diseases |