Exploratory Study on POL6326 in Stem Cell Mobilization

NCT01105403 | Completed Phase 2 DMC

• 1 other identifier: POL-2
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Myeloma

Keywords

Hematopoietic stem cells; Mobilisation; Autologous transplantation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

Study Arms (1)

CD34+ mobilisation for transplantation

EXPERIMENTAL

Drug: POL6326

Interventions

POL6326 DRUG

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

Also known as: not appicable

CD34+ mobilisation for transplantation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Polyphor Ltd.: lead

Study Sites (1)

Department of Internal Medicine V

Heidelberg, 69115, Germany

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

balixafortide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Hartmut Goldschmidt, MD

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 16, 2010
• Study Start: April 1, 2009
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 23, 2014

Record last verified: 2014-04

Locations

DE (1)