Phase II Study of the Adjunctive Use of Lenalidomide in Patients Undergoing Reduced Intensity Conditioning Allogeneic Transplantation for Multiple Myeloma - Post Transplant Lenalidomide for Multiple Myeloma (Version 1)

niversity Hospitals Birmingham NHS Foundation Trust0 sites40 target enrollmentAugust 18, 2010

ConditionsMultiple Myeloma MedDRA version: 16.1Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864

DrugsRevlimid 5mg, hard capsules

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Multiple Myeloma
Sponsor: niversity Hospitals Birmingham NHS Foundation Trust
Enrollment: 40
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 18, 2010

End Date

May 31, 2018

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversity Hospitals Birmingham NHS Foundation Trust

Eligibility Criteria

Inclusion Criteria

•Inclusion Criteria
•Multiple myeloma subjects who have received a high dose melphalan conditioned autologous transplant in the preceding 180 days and who are in CR1 or VGPR1 after their first line of treatment or CR2 or VGPR2 after treatment of first relapse. CR/VGPR are as defined by International uniform response criteria for Myeloma, 2006 (appendix 1\). VGPR for non\-secretory myeloma is not defined in this criteria. For this study VGPR in non\-secretory myeloma patients is defined as a 90% reduction in plasma cells, provided there were 30% or more plasma cells at diagnosis.
•Patients \>18 years and \=70 years in whom allogeneic transplantation using a reduced intensity conditioning regimen is not contra\-indicated but who are not suitable for conventional allograft
•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\)
•Patients with a HLA identical related or ten/ten antigen (A,B,C,DQ,DR) matched unrelated donor
•Cardiac ejection fraction \> 40%. Or report stating left ventricular function is satisfcatory or normal
•Creatinine clearance \>50 ml/min
•Liver function (AST or ALT) \< 2\.5 x upper limit of normal
•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
•Patients willing and able to comply with the protocol for the duration of the study

Exclusion Criteria

•Patients with allergies or contraindications to receiving fludarabine, Lenalidomide, ciclosporin or ATG
•Patients with a known positive serology for HIV/Hepatitis B/Hepatitis C
•Patients who have undergone a previous allogeneic stem cell transplant
•Patients who have previously progressed on Lenalidomide
•Pregnant or lactating women
•Adults of reproductive potential not willing to comply with the Lenalidomide Risk Minimisation Plan (see below for details)
•Patients with organ allografts
•Any co\-morbidity that, in the investigators opinion, would affect the patient’s participation in this study
•Patients who have taken any other investigational medical product within 4 weeks of starting conditioning therapy