Lonquek for Autologous Stem Cell Mobilization

Sheba Medical Center

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Multiple Myeloma; Lymphoma

Treatments: Drug: Lonquek

Study type: Interventional

Funder types: Other

Identifiers

NCT02488382

SHEBA-14-1852-AN-CTIL

Details and patient eligibility

About

The aim of this study is to evaluate the efficacy and tolerability of Lonquek which is a pegylated (long-acting) version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing sufficient number of stem cells for autologous stem cell transplantation in patients with lymphoma and multiple myeloma.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with confirmed multiple myeloma or Hodgkins or non Hodgkin lymphoma at need of autologous stem cell transplantation.
• Disease must be chemosensitive or stable status to prior therapy before transplant.
• Age between 18 and 65 years inclusive.
• ECOG performance status 0, 1 or 2.
• Written informed consent.
• Adequate birth control in fertile patients.

Exclusion criteria

• Lymphoma patients that did not fulfill the inclusion criteria.
• Patients with factors predicting poor mobilization including >3 lines of previous chemotherapy, extensive irradiation, patients that received stem cell toxicity drugs like Melphalan, Fludarabine, >2 courses of Revlimid, age >65 years, platelets counts <100x109/L, WBC<2.5x109/L or WBC > 35x109/L.
• Previous autologous stem cell transplantation.
• Inability to tolerate peripheral blood stem cell harvest.
• Peripheral venous access not possible.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Lonquek

Experimental group

Description:

treatment with Lonquek for autologous stem cell collection

Treatment:

Drug: Lonquek