Exploratory Study on POL6326 in Stem Cell Mobilization

Polyphor

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: POL6326

Study type: Interventional

Funder types: Industry

Identifiers

NCT01105403

POL-2

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

CD34+ mobilisation for transplantation

Experimental group

Treatment:

Drug: POL6326