Exploratory Study on POL6326 in Stem Cell Mobilization

Phase 2

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: POL6326

• Registration Number: NCT01105403
• Lead Sponsor: Polyphor Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-04-13
• Study First Submitted QC: 2010-04-15
• Study First Posted: 2010-04-16
• Primary Completion: 2014-02
• Status Verified: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2014-04-22
• Last Update Posted: 2014-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD34+ mobilisation for transplantation	POL6326	-

Primary Outcome Measures

Name	Time	Method
To assess the ability of POL6326 to mobilise CD34+ hematopoietic stem cells in patients with primary multiple myeloma	Up to four days	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

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Internal Medicine V; 🇩🇪 Heidelberg, Germany