Status:
COMPLETED
MTD, Safety, and Efficacy of Pomalidomide (CC-4047) Alone or With Low-dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma
Lead Sponsor:
Celgene Corporation
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the maximum tolerated dose and effectiveness of the study drug (CC-4047) Alone Or in Combination With Low-dose Dexamethasone as treatment for patients with re...
Detailed Description
The Phase 1 segment of the study was designed to determine the maximum tolerated dose (MTD) of single-agent pomalidomide, which was to be determined in the first cycle of treatment. Following completi...
Eligibility Criteria
Inclusion
- Must be greater than or equal to 18 years at the time of signing the informed consent form
- Must be able to adhere to the study visit schedule and other protocol requirements
- Have a documented diagnosis of multiple myeloma and have relapsed and refractory disease. Patients must have received at least 2 prior therapies. Patients must have relapsed after having achieved at least stable disease for at least one cycle of treatment to at least one prior regimen and then developed PD. Patients must also have documented evidence of PD during or within 60 days (measured from the end of the last cycle) of completing treatment with the last anti-myeloma drug regimen used just prior to study entry (refractory disease)
- Patients must have also undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of bortezomib (either in separate regimens or within the same regimen)
- Measurable levels of myeloma paraprotein in serum (greater than or equal to 0.5 g/dL) or urine (greater than or equal 0.2 g/dL excreted in a 24 hour collection sample)
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Females of childbearing potential (FCBP) \[An FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months)\] must agree to refrain from becoming pregnant for 28 days prior to initiation of study drug, while on study drug and for 28 days after discontinuation of study drug and must agree to regular pregnancy testing during this timeframe.
- All patients must also agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study
- Males must agree to use a latex condom during any sexual contact with FCBP while participating in the study and for 28 days following discontinuation from this study even if he has undergone a successful vasectomy. Males must also agree to refrain from donating blood, semen or sperm during the above referenced timeframe.
- All patients must agree not to share medication with another person.
Exclusion
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form.
- Any serious concurrent medical conditions that may make the patient non-evaluable or put the patient's safety at risk.
- Pregnant or lactating females
- Any of the following laboratory abnormalities:
- Absolute neutrophil count (ANC) \< 1,000 cells/mm3
- Platelet count \< 75,000/mm3 for patients in whom \< 50% of bone marrow nucleated cells are plasma cells; or a platelet count \< 30,000/mm3 for patients in whom ≥ 50% of bone marrow nucleated cells are plasma cells
- Serum creatinine \> 3.0 mg/dL
- Serum glutamic oxaloacetic transaminase/Aspartate transaminase (SGOT/AST) or Serum Glutamic Pyruvate Transaminase/Alanine transaminase (SGPT/ALT) \> 3.0 X upper limit of normal (ULN)
- Serum total bilirubin \> 2.0 mg/dL
- Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:
- Basal or squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix or breast
- Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
- Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection
- Hypersensitivity to thalidomide, lenalidomide, or dexamethasone
- Peripheral neuropathy ≥ Grade 2
- Use of any anti-myeloma drug therapy within 14 days of the initiation of study drug treatment or use of any experimental non-drug therapy within 28 days of the initiation of study drug treatment
- Radiation therapy within 14 days of initiation of study drug treatment Inability or unwillingness to comply with birth control requirements
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
259 Patients enrolled
Trial Details
Trial ID
NCT00833833
Start Date
June 1 2008
End Date
September 1 2015
Last Update
April 27 2016
Active Locations (19)
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1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
2
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
4
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322