bone marrow cancer multiple myeloma
Conditions
Interventions
There are two different treatments that will be compared in this study.
The first study treatment (treatment A) will be a combination of pomalidomide,
bortezomib, and dexamethasone and the second (tr
each cycle will be 21 days
long. The first cycle will start when subjects take their first dose of study
treatment (Cycle 1 Day 1).
The study will last for 5 years.
Sponsors
Celgene Corporation
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects must satisfy the following criteria to be enrolled in the study: 1. Must be >= 18 years at the time of signing the informed consent form. 2. The subject must understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures. 3. Must be able to adhere to the study visit schedule and other protocol requirements. 4. Subjects must have documented diagnosis of multiple myeloma and have measurable disease by serum or urine protein electrophoresis (sPEP or uPEP): sPEP >= 0.5 g/dL or uPEP >= 200 mg/24 hours. 5. All subjects must have had at least 1 but no greater than 3 prior anti-myeloma regimens. (note: induction with or without bone marrow transplant and with or without maintenance therapy is considered one regimen.) 6. All subjects must have documented disease progression during or after their last anti-myeloma therapy. 7. All subjects must have received prior treatment with a lenalidomide-containing regimen for at least 2 consecutive cycles. 8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. 9. Females of childbearing potential (FCBP*) must agree to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 4 weeks before starting study treatment, while participating in the study treatment phase (including dose interruptions), and for at least 4 weeks after the last dose of POM or 3 months after the last dose of BTZ, whichever is longer, and must agree to regular pregnancy testing during this timeframe. 10. Females must agree to abstain from breastfeeding during study treatment and for at least 4 weeks after study treatment discontinuation. 11. Males must agree to use a latex or synthetic condom during any sexual contact with FCBP while participating in the study treatment phase and for at least 4 weeks after the last dose of POM or 3 months after the last dose of BTZ, whichever is longer, even if he has undergone a successful vasectomy. 12. Males must also agree to refrain from donating sperm while on pomalidomide and for 4 weeks after discontinuation from this study treatment. 13. All subjects must agree to refrain from donating blood while on study treatment and for 4 weeks after discontinuation from this study treatment. 14. All subjects must agree not to share medication.
Exclusion criteria
Exclusion criteria: The presence of any of the following will exclude a subject from enrollment: 1. Subjects who had documented progressive disease during therapy or within 60 days of the last dose of a bortezomib-containing therapy under the 1.3 mg/m2 dose twice weekly dosing schedule 2. Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to randomization 3. Non-secretory multiple myeloma 4. Any of the following laboratory abnormalities: • Absolute neutrophil count (ANC) = 50% of bone marrow nucleated cells are plasma cells • Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L) • Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN) • Serum total bilirubin > 1.5 x ULN 5. Subjects with severe renal impairment (Creatinine Clearance [CrCl] = 5 years with the exception of the following non-invasive malignancies: • 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 (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative. 7. Previous therapy with pomalidomide 8. History of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, bortezomib, boron, mannitol, or dexamethasone 9. >= Grade 3 rash during prior thalidomide or lenalidomide therapy 10. Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide 11. Subjects with any one of the following: • Clinically significant abnormal ECG finding at screening • Congestive heart failure (New York Heart Association Class III or IV) • Myocardial infarction within 12 months prior to starting study treatment • Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris 12. Subjects who received any of the following within the last 14 days of initiation of study treatment: • Plasmapheresis • Major surgery (kyphoplasty is not considered major surgery) • Radiation therapy other than local therapy for myeloma associated bone lesions • Use of any systemic anti-myeloma drug therapy 13. Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of treatment 14. Subjects with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis, and lupus, which likely need additional steroid or immunosuppressive treatments in addition to the study treatment. Includes subjects receiving corticosteroids (> 10 mg/day of prednisone or equivalent) within 3 weeks prior to enrollment. 15. Subjects unable or unwilling to undergo protocol required thromboembolism prophylaxis or herpes zoster prophylaxis will not be eligible to participate in this study 16. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study 17. Any serious medical condition, laboratory abnormality,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint • Progression-Free Survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints • Overall Survival (OS) • Safety (type, frequency, seriousness and severity of AEs, and relationship of AEs to study drug or comparator) • Overall response rate (ORR) (using the International Myeloma Working Group Uniform [IMWG] response criteria) • Duration of response Exploratory Endpoints • ORR (using the European Group for Blood and Marrow Transplantation [EBMT] criteria) • Time to response • Time to progression (TTP) • Efficacy analysis in subgroups • Progression-free survival after next-line therapy (PFS2) • POM concentrations in plasma • Clinical benefits (improvement in hemoglobin value, improvement in renal function, improvement of ECOG performance status, improvement in hypercalcaemia, improvement in non-myeloma immunoglobulins) • The European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients with Multiple Myeloma (EORTC QLQ-MY20) Module, the Cancer QoL Questionnaire for Patients with Cancer (EORTC QLQ-C30) Module, and the descriptive system of the EQ-5D • Minimal Residual Disease (MRD), genomic, molecular/mechanistic and immune biomarkers for only those subjects who give their consent (Optional) | — |
Countries
Netherlands
Outcome results
None listed