Multiple Myeloma MedDRA version: 16.1 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Revlimid 5mg, hard capsules
Pharmaceutical Form: Capsule, hard
Sponsors
University Hospitals Birmingham NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion 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) =65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of Lenalidomide given after reduced intensity conditioned stem cell transplant on progression-free survival at 2 years in myeloma ;Secondary Objective: To assess the safety and tolerability of adjuvant Lenalidomide use early after reduced intensity conditioned transplantation To define the potential benefit of combining Lenalidomide with a reduced intensity allograft ;Primary end point(s): Progression Free Survival at 2 years post entry into the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Progression Free Survival at 3 years post-transplantation • Disease Free Survival at 3 years post-transplantation • Toxicity profile of adjunctive Lenalidomide based on CTCAE criteria • Tolerability of adjunctive Lenalidomide • Response to RIC transplantation in combination with adjunctive Lenalidomide defined by the International uniform response criteria for multiple myeloma (Appendix 1)at 3 years post-transplantation • Donor engraftment based on linage-specific chimerism at 2 years post-transplantation • Day +100 and 1 year non-relapse mortality rates • Graft Versus Host Disease based on Glucksberg criteria • Overall survival at 1, 2 and 3 years post-transplant • Second primary malignancy incidence at 3 years post-transplant • Further treatment requirements | — |
Countries
United Kingdom
Outcome results
None listed