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Exploratory Study on POL6326 in Stem Cell Mobilization

Sponsor
Polyphor Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01105403
Collaborator
(none)
21
Enrollment
1
Location
1
Arm
60
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Apr 1, 2009
Actual Primary Completion Date :
Feb 1, 2014
Actual Study Completion Date :
Apr 1, 2014

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. To evaluate the safety and pharmacokinetics of POL6326 in patients with multiple myeloma [2 months]

    2. To determine the efficacy of POL6326 in reconstitution of immune system after transplantation [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    1. All patients have undergone 3 cycles of chemotherapy, with the last dose of chemotherapy given 3 to 8 weeks before study entry.

    2. Eastern Cooperative Oncology Group (ECOG) performance status of 2.

    3. Life expectancy of >6 months.

    4. 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.

    1. Pregnant or lactating female patients.

    2. Known history of HIV infection or chronic hepatitis B or C infection.

    3. Receipt of immunotherapy, radiation therapy, or any investigational drug within 30 days of study drug administration.

    4. Prior radiotherapy to more than 3 vertebrae.

    5. Active serious bacterial or fungal infections; >grade 3 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).

    6. Receipt of haematopoietic cytokines within 10 days of study drug administration.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Internal Medicine V Heidelberg Germany 69115

    Sponsors and Collaborators

    • Polyphor Ltd.

    Investigators

    • Principal Investigator: Hartmut Goldschmidt, MD, Heidelberg University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Polyphor Ltd.
    ClinicalTrials.gov Identifier:
    NCT01105403
    Other Study ID Numbers:
    • POL-2
    First Posted:
    Apr 16, 2010
    Last Update Posted:
    Apr 23, 2014
    Last Verified:
    Apr 1, 2014
    Keywords provided by Polyphor Ltd.
    Hematopoietic stem cells
    Mobilisation
    Autologous transplantation
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell

    Study Results

    No Results Posted as of Apr 23, 2014