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Trial · Interventional

CompletedPhase 2Registry data

Exploratory Study on POL6326 in Stem Cell Mobilization

NCTNCT01105403 (opens ClinicalTrials.gov in a new tab)Other idPOL-2
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
21 participants (actual)
Sponsor
Polyphor Ltd. · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Germany

Start
Apr 2009
Primary completion
Feb 2014
Completion
Apr 2014
First posted
16 Apr 2010 (estimated)
Last update posted
23 Apr 2014 (estimated)
Conditions
Multiple Myeloma

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2009201020112012201320142015
  1. Ph 2

    Exploratory Study on POL6326 in Stem Cell Mobilization

    NCT01105403

    Apr 2009 to Apr 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • POL6326Drug

Arms1

  • Experimental

    CD34+ mobilisation for transplantation

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Up to four days

    Registry description

    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 outcomes(2)

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

    Time frame · 2 months

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

    Time frame · 1 year

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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