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Exploratory Study on POL6326 in Stem Cell Mobilization

Primary Purpose

Multiple Myeloma

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

POL6326

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Hematopoietic stem cells, Mobilisation, Autologous transplantation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Department of Internal Medicine V

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CD34+ mobilisation for transplantation

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

To evaluate the safety and pharmacokinetics of POL6326 in patients with multiple myeloma

To determine the efficacy of POL6326 in reconstitution of immune system after transplantation

Full Information

NCT ID

NCT01105403

First Posted

April 13, 2010

Last Updated

April 22, 2014

Sponsor

Polyphor Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01105403

Brief Title

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

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Polyphor Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

Hematopoietic stem cells, Mobilisation, Autologous transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CD34+ mobilisation for transplantation

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

POL6326

Other Intervention Name(s)

not appicable

Intervention Description

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

Primary Outcome Measure Information:

Title

To assess the ability of POL6326 to mobilise CD34+ hematopoietic stem cells in patients with primary multiple myeloma

Description

Time Frame

Up to four days

Secondary Outcome Measure Information:

Title

To evaluate the safety and pharmacokinetics of POL6326 in patients with multiple myeloma

Time Frame

2 months

Title

To determine the efficacy of POL6326 in reconstitution of immune system after transplantation

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hartmut Goldschmidt, MD

Organizational Affiliation

Heidelberg University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Internal Medicine V

City

Heidelberg

ZIP/Postal Code

69115

Country

Germany

12. IPD Sharing Statement

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Exploratory Study on POL6326 in Stem Cell Mobilization

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