ISRCTN16228367
Completed
Phase 2
Phase II study of the adjuvant use of lenalidomide in patients undergoing reduced intensity conditioning allogenic transplantation for multiple myeloma
niversity Hospitals Birmingham NHS Foundation Trust (UK)0 sites40 target enrollmentMay 24, 2011
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Haematological Oncology, Myeloma
- Sponsor
- niversity Hospitals Birmingham NHS Foundation Trust (UK)
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Multiple myeloma subjects who have received a high dose melphalan conditioned autologous transplant in the preceding 120 days and who are in CR1/2 or VGPR1/2 as defined by International uniform response criteria for Myeloma, 2006 (Appendix 1\)
- •2\. Patients 18 to 70 years in whom allogeneic transplantation using a reduced intensity conditioning regimen is not contra\-indicated but who are not suitable for conventional allograft
- •3\. Eastern Cooperative Oncology Group (ECOG) status \<2 or an ECOG status of 3 if the reason for a status of 3 is due exclusively to multiple myeloma (e.g. pathological fracture) (Appendix 2\)
- •4\. Patients with a HLA identical sibling or ten/ten antigen (A,B,C,DR,DQ) matched unrelated donor
- •5\. Cardiac ejection fraction \> 40%
- •6\. Measured EDTA Creatinine clearance \>50 ml/min
- •7\. Carbon Monoxide Diffusing Capacity (DLCO) \>50%
- •8\. Liver function (AST or ALT) \< 2\.5 x upper limit of normal
- •9\. Patients able to give written informed consent prior to allogeneic transplant, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
- •10\. Patients willing and able to comply with the protocol for the duration of the study
Exclusion Criteria
- •1\. Patients with allergies or contraindications to receiving Fludarabine, Lenalidomide, ciclosporin or ATG
- •2\. Pregnant or lactating women
- •3\. Adults of reproductive potential not willing to comply with the Lenalidomide Risk Minimisation Plan
- •4\. Patients with organ allografts
- •5\. Any co\-morbidity that, in the investigators opinion, would affect the patient?s participation in this study
- •6\. Patient who have taken any other investigational medical product within 4 weeks of starting conditioning therapy
- •Added 10/07/2017:
- •7\. Patients with known positive serology for HIV/Hepatitis B/Hepatitis C
- •8\. Patients who have undergone a previous allogeneic stem cell transplant
- •9\. Patients who have previously progressed on Lenalidomide
Outcomes
Primary Outcomes
Not specified
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