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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

Phase 2
18 Years
70 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

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

Inclusion Criteria:

1. Have multiple myeloma in Stage II or III, according to the criteria of Durie and

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

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.

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome 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)

Outcome Time Frame:

Up to four days

Safety Issue:


Principal Investigator

Hartmut Goldschmidt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Heidelberg


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

April 2009

Completion Date:

December 2013

Related Keywords:

  • Multiple Myeloma
  • Hematopoietic stem cells
  • Mobilisation
  • Autologous transplantation
  • Multiple Myeloma
  • Neoplasms, Plasma Cell