Exploratory Study on POL6326 in Stem Cell Mobilization

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

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

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: POL6326

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69115
    • Department of Internal Medicine V

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CD34+ mobilisation for transplantation	Drug: POL6326; IV infusion of POL6326 followed by apheresis to collect mobilized stem cells from peripheral blood; Other Names: not appicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the ability of POL6326 to mobilise CD34+ hematopoietic stem cells in patients with primary multiple myeloma	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)	Up to four days

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the safety and pharmacokinetics of POL6326 in patients with multiple myeloma	2 months
To determine the efficacy of POL6326 in reconstitution of immune system after transplantation	1 year

Collaborators and Investigators

• Sponsor: Polyphor Ltd.
• Investigators: Principal Investigator: Hartmut Goldschmidt, MD, Heidelberg University

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: April 13, 2010
• First Submitted That Met QC Criteria: April 15, 2010
• First Posted (Estimate): April 16, 2010

Study Record Updates

• Last Update Posted (Estimate): April 23, 2014
• Last Update Submitted That Met QC Criteria: April 22, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Autologous transplantation; Hematopoietic stem cells; Mobilisation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: POL-2