ACTRN12616000777493
Completed
Phase 2
Safety and tolerability of lenalidomide consolidation post allogeneic stem cell transplant for patients with high risk multiple myeloma failing to achieve stringent Complete Response
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Myeloma
- Sponsor
- Alfred Health
- Enrollment
- 3
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pre allo\-SCT
- •1\. Age \>18 years of age
- •2\. Diagnosis of multiple myeloma as per IMWG criteria:
- •a. Clonal plasma cells greater than 10%
- •b. Presence of serum and/or urinary monoclonal protein (except in patients with true non\-secretory multiple myeloma), and
- •c. Evidence of end\-organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically
- •i.\[C] Hypercalcaemia: serum calcium greater than or equal to 11\.5mg/100ml or
- •ii.\[R] Renal insufficiency: serum creatinine \> 173 micro mol/l or
- •iii.\[A] Anaemia: normocytic, normochromic with a haemoglobin value of \>20g/l below the lower limit of normal or a haemoglobin value \<100g/l or
- •iv.\[B] Bone lesions: lytic lesions, severe osteopenia or pathologic fractures.
Exclusion Criteria
- •Post allo\-SCT
- •1\. Current active graft versus host disease (acute or chronic) requiring immunosuppression
- •2\. Prior acute graft versus host disease grade II\-IV
- •3\. Received donor lymphocyte infusion (DLI) within 8 weeks of commencing study drug
- •4\. Uncontrolled medical illness or infections
- •5\. Relapsed/progressive myeloma
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Safety And Efficacy Of Lenalidomide As Maintenance Therapy In Patients With Newly Diagnosed Multiple Myeloma Following A Tandem Autologous-Allogeneic Transplant - MM-ALLO-06-07_BISPatients With Newly Diagnosed Multiple MyelomaMedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myelomaEUCTR2008-004529-41-ITFONDAZIONE NEOPLASIE SANGUE ONLUS12
Active, not recruiting
Not Applicable
Feasibility and efficacy of Lenalidomide maintenance after salvage immuno-chemotherapy induction in relapsed or refractory mantle cell lymphoma - a phase II study of the European MCL Networkpatients with relapsed or refractory mantle cell lymphoma after or not eligible for myeloablative treatmentMedDRA version: 12.0Level: PTClassification code 10026800Term: Mantle cell lymphoma recurrentMedDRA version: 12.0Level: PTClassification code 10026801Term: Mantle cell lymphoma refractoryEUCTR2008-000678-19-DEKlinikum der Universität München, Klinikum Großhadern60
Active, not recruiting
Phase 1
Pilot safety/tolerability study of Lenalidomide administered as monotherapy and in combination with standard chemotherapy for Acute Myeloid Leukaemia/high-risk myelodysplastic syndrome with structural abnormalities of chromosome 5 - AML Len5EUCTR2008-004891-28-GBeeds Teaching Hospitals Trust14
Terminated
Phase 1
Lenalidomide in Combination With Microtransplantation as Post-remission Therapy in AMLAcute Myeloid Leukemia (AML)Acute Myelocytic LeukemiaAcute Myelogenous LeukemiaAcute Granulocytic LeukemiaAcute Non-Lymphocytic LeukemiaNCT02255162Massachusetts General Hospital8
Active, not recruiting
Not Applicable
Evaluation of efficacy and safety of Lenalidomide (Revlimid) in patients with POEMS Syndrome - ONC-2008-002POEMS SYNDROMEMedDRA version: 9.1Level: SOCClassification code 10029205EUCTR2008-003202-33-ITISTITUTO CLINICO HUMANITAS