Phase II study of the adjuvant use of lenalidomide in patients undergoing reduced intensity conditioning allogenic transplantation for multiple myeloma
- Conditions
- Haematological Oncology, MyelomaCancerMyeloma
- Registration Number
- ISRCTN16228367
- Lead Sponsor
- niversity Hospitals Birmingham NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
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
11. Agree to abstain from donating blood (and semen in male subjects) while taking study drug therapy and for 28 days following discontinuation of study drug therapy
12. Agree not to share study drug with another person and to return all unused study drug to the investigator or pharmacist
13. Male or female
14. Upper age limit 70 years
15. Lower age limit 18 years
Updated 10/07/2017: upper age limit changed from 65 to 70 years.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Progression free survival at 2 years post transplant<br> 2. Timepoint(s): 2 years post transplant<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Day +100 and 1 year non-relapse mortality, timepoint(s): day 100 and year 1<br> 2. Disease free survival at 1 and 2 years post transplant, timepoint(s): Markers of disease assessed at months 1, 3, 6, 9, 12, 15, 18, 21 and 24 post transplant<br> 3. Donor engraftment, timepoint(s): lineage-specific chimerism assessed at months 1, 3, 6, 9, 12, 15, 18, 21 and 24 post-transplant<br> 4. GVHD, timepoint(s): GVHD will be monitored continuously until 2 years post transplant<br> 5. Overall survival at years 1 and 2 post transplant, timepoint(s): will be monitored continuously until 24 months post-transplant<br>