Multiple Myeloma Clinical Trial
Official title:
Lonquek (Lipegfilgrastim) for Stem Cell Mobilization of Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma and Lymphoma
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.
| Status | Recruiting |
| Enrollment | 24 |
| Est. completion date | July 2020 |
| Est. primary completion date | July 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Chaim Sheba Medical Center | Tel-Hashomer |
| Lead Sponsor | Collaborator |
|---|---|
| Sheba Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mobilisation success rate | Mobilisation success rate is defined as the mobilisation of a peripheral blood stem cell graft containing >2x106 CD34+ cells/kg in = 4 apheresis sessions. | 4 weeks | |
| Secondary | engraftment after transplantation | Time until recovery of blood counts after transplantation | 100 days | |
| Secondary | Safety | Number of participants with adverse events | 100 days |
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