A Phase IIa, Proof of Concept Study to Determine the Degree of Mobilisation of CD34+ Cells Following Administration of POL6326 in Patients with Multiple Myeloma

• Conditions: Multiple Myeloma; MedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma

• Registration Number: EUCTR2008-005046-23-DE
• Lead Sponsor: Polyphor AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 36

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.Historic (i.e. before induction therapy) and/or current 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.Have undergone 3 cycles of induction chemotherapy, with the last dose of IV chemotherapy given 3 to 8 weeks before receipt of POL6326.
5.Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2.
6.Life expectancy of >6 months.
7.Have given their written informed consent to participate in the study
8. Have not previously received G-CSF and not undergone haematopoietic stem cell transplantation.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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, or 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 >2.5 x ULN
•Amylase and lipase >1.5 x ULN
•Serum creatinine >2.0 x ULN
•Prothrombin time (PT) and activated partial thermoplastic 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) Version 3.0.
11.Receipt of haematopoietic cytokines within 10 days of study drug administration.

Patients must be compliant with all inclusion and exclusion criteria to be eligible for inclusion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified