Multiple Myeloma MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Product Name: POL6326
Product Code: POL6326
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: POL6326
CAS Number: 1051366-32-5
Concentration unit: mg/ml milligram(s)/mil
Sponsors
Polyphor AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have multiple myeloma in Stage II or III, according to the criteria of Durie and Salmon 2. Male or female between 18 and 70 years of age, inclusive. Male and females capable of reproduction must agree to use adequate contraceptive measures (e.g. condom, intrauterine device, oral contraceptive) until 3 months after termination of treatment. 3. Historic (i.e. before induction therapy) and/or current Measurable disease, defined by one of the following: • Serum M protein =1.0 g/dL by protein electrophoresis • Quantifiable immunoglobulin levels and/or urinary M protein excretion =200 mg/24 hours. 4. Have undergone 3 cycles of induction chemotherapy, with the last dose of IV chemotherapy given 3 to 8 weeks before receipt of POL6326. 5. Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2. 6. Life expectancy of >6 months. 7. Have given their written informed consent to participate in the study 8. Have not previously received G-CSF and not undergone haematopoietic stem cell transplantation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Have non secretory myeloma and/or plasma cell leukaemia. 2. History of other malignancies during the past 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, or cervical carcinoma, or localised prostate carcinoma. 3. Any other clinically significant medical conditions. 4. History of cardiac disease NHYA classification =3 5. Insufficient bone marrow, liver and renal function as assessed by the following clinical laboratory evaluations: • Haemoglobin 1.5 x upper limit of normal (ULN) • Alanine aminotransferase (ALT) and alkaline phosphatase >2.5 x ULN • Amylase and lipase >1.5 x ULN • Serum creatinine >2.0 x ULN • Prothrombin time (PT) and activated partial thermoplastic time (APTT) >1.5 x ULN 6. Pregnant or lactating female patients. 7. Known history of HIV infection or chronic hepatitis B or C infection. 8. Receipt of immunotherapy, radiation therapy, or any investigational drug within 30 days of study drug administration. 9. Prior radiotherapy to more than 3 vertebrae. 10. Active serious bacterial or fungal infections; =grade 3 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. 11. Receipt of haematopoietic cytokines within 10 days of study drug administration. Patients must be compliant with all inclusion and exclusion criteria to be eligible for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the ability of POL6326 to mobilise CD (cluster of differentiation) 34+ cells in newly-diagnosed patients with multiple myeloma following intravenous (IV) infusion of POL6326 after pre treatment with three cycles of standard induction with a bortezomib or thalidomide based induction therapy, including adriamycin and/or dexamethasone, such as bortezomib + dexamethasone (PD), bortezomib + adriamycin + dexamethasone (PAD), thalidomide + dexamethasone (TD) or thalidomide + adriamycin + dexamethasone (TAD).;Secondary Objective: •To determine the safety and tolerability of POL6326 following 2-hour IV infusions in patients with multiple myeloma. •To determine th2-hour IV infusions e pharmacokinetic profile of POL6326 in plasma following 2-hour infusions in patients with multiple myeloma. •To determine efficacy in terms of haematopoietic reconstitution after high-dose melphalan following transplantation using stem cells mobilised by POL6326. ;Primary end point(s): The primary efficacy endpoint is: • Percentage of patients achieving the minimal number of CD34+ cells (=2 x 106/kg Body Weight:BW) collected during one to three cycles of apheresis which are considered necessary and safe to proceed with autotransplantation. The secondary efficacy endpoints are: • The degree of CD34+ mobilisation in peripheral blood following 2 hour infusion of POL6326. Successful mobilisation is defined as =2 fold increase in CD34+ count or a count of at least 2-5 CD34+/µl following infusion of POL6326 and prior to apheresis compared to baseline (pre infusion). • Number of CD34+ cells collected during each cycle of apheresis. • The number of apheresis cycles and volume of apheresis required to obtain the minimal number of CD34+ cells necessary for autotransplantation (=2 x 106/kg BW). • The number of tumour cells in apheresis product collected following the first dose of POL6326 compared with the number of tumour cells in product collected in the first apheresis cy | — |
Countries
Germany
Outcome results
None listed