Exploratory Study on POL6326 in Stem Cell Mobilization
This study is currently recruiting participants.
Verified March 2013 by Polyphor Ltd.
Information provided by (Responsible Party):
First received: April 13, 2010
Last updated: March 30, 2013
Last verified: March 2013
The purpose of this study is to determine whether POL6326 is safe and clinically active to mobilize hematopoietic stem cells followed by transplantation
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase IIa, Proof of Concept Study is to Determine the Degree of Mobilisation of CD34+ Cells Following Administration of POL6326 in Patients With Multiple Myeloma
Primary Outcome Measures:
- To assess the ability of POL6326 to mobilise CD34+ hematopoietic stem cells in patients with primary multiple myeloma [ Time Frame: Up to four days ] [ Designated as safety issue: No ]
Number of patients achieving the minimal number of CD34+ cells (≥2 x 10 mill/kg BW) collected during one to four cycles of apheresis which are considered necessary and safe to proceed with autotransplantation
Number of apheresis cycles required to obtain the minimal number of CD34+ cells necessary for autotransplantation (≥2 x 10 mill/kg BW)
Secondary Outcome Measures:
- To evaluate the safety and pharmacokinetics of POL6326 in patients with multiple myeloma [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- To determine the efficacy of POL6326 in reconstitution of immune system after transplantation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
Experimental: CD34+ mobilisation for transplantation
IV infusion of POL6326 followed by apheresis to collect mobilized stem cells from peripheral blood
Other Name: not appicable
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Have multiple myeloma in Stage II or III, according to the criteria of Durie and Salmon.
- 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.
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.
- All patients have undergone 3 cycles of chemotherapy, with the last dose of chemotherapy given 3 to 8 weeks before study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2.
- Life expectancy of >6 months.
- Have given their written informed consent to participate in the study
- Have non-secretory myeloma and/or plasma cell leukaemia.
- History of other malignancies during the past 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma, or localised prostate carcinoma.
- Any other clinically significant medical conditions.
- History of cardiac disease NHYA classification ≥3.
Insufficient bone marrow, liver and renal function as assessed by the following clinical laboratory evaluations:
Haemoglobin <9.0 g/L. Absolute neutrophil count <1500/µL. Platelet count <50000/µL. Total bilirubin >1.5 x upper limit of normal (ULN). Alanine aminotransferase (ALT) and alkaline phosphatase (AP) >2.5 x ULN. Amylase and lipase >1.5 x ULN. Serum creatinine >2.0 x ULN. Prothrombin time (PT) and activated partial thrombo-plastin time (aPTT) >1.5 x ULN.
- Pregnant or lactating female patients.
- Known history of HIV infection or chronic hepatitis B or C infection.
- Receipt of immunotherapy, radiation therapy, or any investigational drug within 30 days of study drug administration.
- Prior radiotherapy to more than 3 vertebrae.
- Active serious bacterial or fungal infections; >grade 3 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
- Receipt of haematopoietic cytokines within 10 days of study drug administration.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105403
|Department of Internal Medicine V
|Heidelberg, Germany, 69115 |
|Contact: Hartmut Goldschmidt, MD |
|Principal Investigator: Hartmut Goldschmidt, MD |
||Hartmut Goldschmidt, MD
||University of Heidelberg
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 13, 2010
||March 30, 2013
||Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by Polyphor Ltd.:
Hematopoietic stem cells
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 19, 2013
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases