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A Study to Compare MPR With MP in Newly Diagnosed Multiple Myeloma Subjects 65 Years Old or Older
This study is currently recruiting participants.
Verified by Celgene Corporation, March 2007
Sponsors and Collaborators: Celgene Corporation
Parexel
Information provided by: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00405756
  Purpose

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
Newly Diagnosed Multiple Myeloma
Drug: Lenalidomide
Phase III

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
Drug Information available for: Prednisone Melphalan Melphalan hydrochloride Sarcolysin Lenalidomide CC 5013
U.S. FDA Resources
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

Further study details as provided by Celgene Corporation:

Estimated Enrollment: 450
Study Start Date: January 2007
Estimated Study Completion Date: December 2012
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Must understand and voluntarily sign an informed consent form
  2. Age greater than or equal to 65 years at the time of signing the informed consent
  3. Newly diagnosed with symptomatic multiple myeloma as defined by the 3 criteria below:

MM diagnostic criteria (all 3 required)

  1. Monoclonal plasma cells in the bone marrow greater than or equal to 10% and/or presence of a biopsy-proven plasmacytoma
  2. Monoclonal protein present in the serum and/or urine
  3. Myeloma-related organ dysfunction (at least one of the following)* [C] Calcium elevation in the blood (serum calcium >10.5mg/dl or upper limit of normal) [R] Renal insufficiency (serum creatinine >2mg/dl) [A] Anaemia (haemoglobin <10g/dl or 2g < normal) [B] Lytic bone lesions or osteoporosis+ AND have measurable disease as defined by the following; IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level greater than or equal to 1.0 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours IgA multiple myeloma: Serum M-protein level greater than or equal to 0.5 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours IgD multiple myeloma: Serum M-protein level greater than or equal to 0.05 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours Light chain multiple myeloma: Serum M-protein level greater than or equal to 1.0 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours
  4. Karnofsky performance status greater than or equal to 60%.
  5. Able to adhere to the study visit schedule and other protocol requirements.
  6. Females of childbearing potential (FCBP**) must agree to use two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual intercourse during the time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device [IUD], hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods, if needed.

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

  1. Previous treatment with antimyeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 28 days [4 weeks] of randomisation]).
  2. Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds experimental the ability to interpret data from the study.
  3. Pregnant or lactating females.
  4. Radiotherapy within 28 days (4 weeks) of randomisation.
  5. Plasmapheresis within 28 days (4 weeks) of randomisation.
  6. 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)

  7. 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)

  8. Neuropathy of ³ grade 2 severity.
  9. Known HIV positivity or active infectious hepatitis, type A, B or C.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00405756

Contacts
Contact: Robert Knight, MD rknight@celgene.com

  Show 87 Study Locations
Sponsors and Collaborators
Celgene Corporation
Parexel
Investigators
Principal Investigator: Attonio Palumbo Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
  More Information

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

Keywords provided by Celgene Corporation:
Newly Diagnosed Multiple Myeloma
Celgene
CC-5013
Revlimid
Lenalidomide
Melphalan
Prednisone
Elderly

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009