a type of bone marrow cancer multiple myeloma
Conditions
Interventions
All subjects will be treated with open label Pomalidomide (POM). POM will be
supplied as Investigational Product by Celgene Corporation as 1 mg, 2 mg, 3 mg,
and 4 mg capsules for oral administration
Sponsors
Celgene Corporation
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Must be * 18 years at the time of signing the informed consent document (ICD).;2. The subject must understand and voluntarily sign an ICD prior to any study related assessments/procedures being conducted.;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 (serum M-protein * 0.5 g/dL or urine M-protein * 200 mg/24 hours).;5. Subjects must have undergone prior treatment with * 2 treatment lines of anti-myeloma therapy. Induction therapy followed by ASCT and consolidation/maintenance will be considered as one line. A new treatment line is always started after progressive disease.;6. Subjects must have either refractory or relapsed and refractory disease defined as documented disease progression during or within 60 days of completing their last myeloma therapy. Primary refractory: Subjects who have never achieved any response better than PD to any previous line of anti-myeloma therapy. Relapsed and refractory: Subjects who have relapsed after having achieved at least stable disease for at least two cycles of treatment to at least one prior regimen and then developed PD on or within 60 days of completing their last myeloma therapy.;7. All subjects must have received at least 2 consecutive cycles of prior treatment that included lenalidomide and bortezomib, either alone or in combination regimens. All subjects must have failed both lenalidomide and bortezomib and medical records must be available that provide documentation of the following criteria for refractoriness that make the subject eligible for the study. -All subjects must have failed treatment with the last lenalidomide-containing regimen in one of the following ways: * Documented PD during or within 60 days of completing last treatment with lenalidomide, regardless of the response achieved, or * In case of prior response (* partial response - PR) to lenalidomide and PD > 60 days, subjects must have relapsed within 6 months after the last dose of treatment with lenalidomide-containing regimens. -All subjects must have failed treatment with the last bortezomib-containing regimen in one of the following ways: * Documented PD during or within 60 days of completing treatment with bortezomib, regardless of the response achieved, or * In case of prior response (* PR) to bortezomib and PD > 60 days, subjects must have relapsed within 6 months after the last dose of treatment with bortezomib-containing regimens Or for non-progressive subjects: * Subjects who have less than MR response and have developed intolerance/toxicity after a minimum of two cycles of a bortezomib-containing regimen. Toxicity such as > grade 2 peripheral neuropathy or * grade 2 painful neuropathy. Peripheral neuropathy must resolve to grade 1 prior to study entry.;8. Subjects must have received adequate prior alkylator therapy in one of the following ways: -As part of a stem cell transplant; or -A minimum of 4 consecutive cycles of an alkylator based therapy; or -Progression on treatment with an alkylator; provided that the subject received at least 2 cycles of an alkylator-containing therapy.;9. ECOG performance status score of 0, 1, or 2.;10. 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
Exclusion criteria
Exclusion criteria: 1. Any of the following laboratory abnormalities: -Absolute neutrophil count 14 mg/dL (> 3.5 mmol/L). -Hemoglobin 3.0 x upper limit of normal (ULN). -Serum total bilirubin > 2.0 mg/dL (34.2 *mol/L); or > 3.0 x ULN for subjects with hereditary benign hyperbilirubinemia.;2. Prior history of malignancies, other than MM, unless the subject has been free of the disease for * 5 years. Exceptions include the following: -Basal or squamous cell carcinoma of the skin -Carcinoma in situ of the cervix or breast -Incidental histological finding of prostate cancer (TNM stage of T1a or T1b).;3. Previous therapy with POM.;4. Hypersensitivity to thalidomide, lenalidomide, or DEX (this includes * Grade 3 rash during prior thalidomide or lenalidomide therapy).;5. Peripheral neuropathy * Grade 2.;6. Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant less than 12 months prior to initiation of study treatment and who have not discontinued immunosuppressive treatment for at least 4 weeks prior to initiation of study treatment and are currently dependent on such treatment.;7. Subjects who are planning for or who are eligible for stem cell transplant.;8. Subjects with any one of the following: -Congestive heart failure (NY 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.;9. Subjects who received any of the following within the last 14 days of initiation of study treatment: -Major surgery (kyphoplasty is not considered major surgery) -Use of any anti-myeloma drug therapy.;10. Use of any investigational agents within 28 days or five half-lives (whichever is longer) of treatment, unless approved by the Sponsor.;11. Incidence of gastrointestinal disease that may significantly alter the absorption of POM.;12. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment.;13. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subjects from signing the ICD or participating in the study.;14. Pregnant or breastfeeding females.;15. Known human immunodeficiency virus (HIV) positivity, active infectious hepatitis A, B or C or chronic hepatitis B or C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: Adverse events (AEs) assessment (type, frequency, seriousness, severity, relationship to POM and/or DEX and outcomes), including second primary malignancies (SPM). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: - POM exposure - POM population pharmacokinetics and exposure-response - Overall response rate (ORR) - Time to response - Duration of response (DoR) - Progression-free survival (PFS) - Time to progression (TTP) - Overall survival (OS) Exploratory Endpoints: - Evaluation of markers that might predict response to POM - Evaluation of markers that might predict resistance to POM - Analysis of pharmacodynamic markers for POM | — |
Countries
Netherlands
Outcome results
None listed