Clinical trial NCT01105403: Exploratory Study on POL6326 in Stem Cell Mobilization
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Hematopoietic stem cells
Mobilisation
Autologous transplantation
Lead sponsor: Polyphor Ltd.
Sponsor class: INDUSTRY
First posted: 2010-04-16
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether POL6326 is safe and clinically active to mobilize hematopoietic stem cells followed by transplantation


Eligibility 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. 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. All patients have undergone 3 cycles of chemotherapy, with the last dose of chemotherapy given 3 to 8 weeks before study entry.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 2.
6. Life expectancy of \>6 months.
7. Have given their written informed consent to participate in the study

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, 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 \<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.
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).
11. Receipt of haematopoietic cytokines within 10 days of study drug administration.

Primary outcomes:
measure: To assess the ability of POL6326 to mobilise CD34+ hematopoietic stem cells in patients with primary multiple myeloma
timeFrame: Up to four days
Secondary outcomes:
measure: To evaluate the safety and pharmacokinetics of POL6326 in patients with multiple myeloma
timeFrame: 2 months
measure: To determine the efficacy of POL6326 in reconstitution of immune system after transplantation
timeFrame: 1 year
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Internal Medicine V
Study officials:
affiliation: Heidelberg University
name: Hartmut Goldschmidt, MD
role: PRINCIPAL_INVESTIGATOR
References: