Refractory or refractory multiple myeloma (MM) in patients with moderate or severely impaired renal function. MedDRA version: 14.1 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Product Name: Pomalidomide
Product Code: CC-4047
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pomalidomide
CAS Number: 19171-19-8
Other descriptive name: POMALIDOMIDE
Concentration unit: mg
Sponsors
Celgene Corporation
Eligibility
Sex/Gender
All
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. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted. 3. 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 had at least 1 prior antimyeloma regimen including lenalidomide and documented progression as per the IMWG uniform response criteria (Durie, 2006) during or after the last antimyeloma regimen. Induction therapy followed by ASCT and consolidation/ maintenance will be considered as one regimen. 6. Subjects must have an impaired renal function with an estimated GFR of =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: The presence of any of the following will exclude a subject from enrollment 1. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 2. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. 3. Renal insufficiency due to other reasons than multiple myeloma or due to hypocalcaemia only. 4. Any of the following laboratory abnormalities: a. Absolute neutrophil count (ANC) 14 mg/dL (> 3.5 mmol/L) d. Hemoglobin 3.0 x upper limit of normal (ULN) f. Serum total bilirubin > 2.0 mg/dL (34.2 µmol/L); or > 3.0 x ULN for subjects with hereditary benign hyperbilirubinemia 5. Prior history of malignancies, other than MM, unless the subject has been free of the disease for = 5 years; exceptions include the following: a. Basal or squamous cell carcinoma of the skin b. Carcinoma in situ of the cervix or breast c. Incidental histological finding of prostate cancer (TNM stage of T1a or T1b) 6. Previous therapy with pomalidomide. 7. Hypersensitivity to thalidomide, lenalidomide, or dexamethasone (this includes = Grade 3 rash during prior thalidomide or lenalidomide therapy). 8. Peripheral neuropathy = Grade 2. 9. 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. 10. Subjects who are planning for or who are eligible for stem cell transplant. 11. Subjects with any one of the following: a. Congestive heart failure (NY Heart Association Class III or IV) b. Myocardial infarction within 12 months prior to starting study treatment c. 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: a. Major surgery (kyphoplasty is not considered major surgery) b. Use of any antimyeloma drug therapy 13. Use of any investigational agents within 28 days or five half-lives (whichever is longer) of treatment. 14. Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide. 15. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment. 16. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subjects from signing the informed consent form. 17. Pregnant or breastfeeding females. 18. Known human immunodeficiency virus (HIV) positivity, active infectious hepatitis A, B, or C or chronic hepatitis B or C. 19. Any condition that confounds the ability to interpret data from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate efficacy of the combination of pomalidomide and low-dose dexamethasone in subjects with RRMM and impaired renal function.;Secondary Objective: - Evaluate renal efficacy of the combination of pomalidomide and low-dose dexamethasone in subjects with various degrees of renal impairment. - Evaluate safety and tolerability of the combination of pomalidomide and low-dose dexamethasone in subjects with RRMM and impaired renal function. - Evaluate the pharmacokinetics of pomalidomide in subjects with various degrees of renal impairment.;Primary end point(s): Overall response rate (ORR) according to the International Myeloma Working Group (IMWG) criteria;Timepoint(s) of evaluation of this end point: At Day 1 of each Cycle starting at Cycle 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Assessment of renal response. 2) Time to Myeloma response, time to renal response, duration of response (DOR), progression-free survival (PFS), time to progression (TTP), overall survival (OS). 3) Adverse events (AEs) assessment (type, frequency, seriousness, severity, relationship to pomalidomide and/or dexamethasone and outcomes) including second primary malignancy (SPM). 4) Pharmacokinetics (PK) of pomalidomide in subjects with RRMM and impaired renal function (moderate to severe renal impairment).;Timepoint(s) of evaluation of this end point: a) Assessment of renal response, Time to myeloma response, Time to renal response, PFS and TTP will be assesssed at Day 1 of each Cycle starting at Cycle 2 b) Duration of response - depending on when a response occurs c) OS – continuously during the trial as well as during FU d) AEs – continuously during the trial as well as during FU e) PK – Please see page 34 of the protocol | — |
Countries
France, Germany, Greece, Italy, Netherlands, Spain, United Kingdom
Contacts
Public ContactClinicalTrialDisclosure
Celgene Corporation
Outcome results
None listed