Exploratory Study on POL6326 in Stem Cell Mobilization

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01105403
• Other study ID #: POL-2
• Status: Completed
• Phase: Phase 2
• First received: April 13, 2010
• Last updated: April 22, 2014
• Start date: April 2009
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Polyphor Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• POL6326
IV infusion of POL6326 followed by apheresis to collect mobilized stem cells from peripheral blood

Locations

Country	Name	City	State
Germany	Department of Internal Medicine V	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Polyphor Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To evaluate the safety and pharmacokinetics of POL6326 in patients with multiple myeloma		2 months	Yes
Secondary	To determine the efficacy of POL6326 in reconstitution of immune system after transplantation		1 year	No