Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06457464
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-08
Brief Title:
Clinical Outcomes and Prognostic Factors in Multiple Myeloma Patients
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Clinical Outcomes and Prognostic Factors in Patients With Multiple Myeloma in Assuit University Hospitals Prospective and Retrospective Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 Description of the demographic clinical and laboratory characteristics of patients with MM admitted to the hematology unit of Assuit University Hospitals
2 Determination of treatment outcomes and prognostic factors associated with survival rates
2 Determination of treatment outcomes and prognostic factors associated with survival rates
Detailed Description:
Multiple Myeloma MM plasma cell myeloma represents a malignant proliferation of plasma cells derived from B cells Its median age of diagnosis is 52-61 years but is less common under 40 years Males are affected more than females
Diagnostic criteria for Multiple Myeloma
1 Clonal bone marrow plasma cells or biopsy-proven bony or extramedullary plasmacytoma and any one of the following myeloma-defining events
2 Evidence of one or more end-organ damage that can be attributed to the underlying plasma cell proliferative disorder specifically
Hypercalcemia serum calcium 025mmoll1 mg dl higher than the upper limit of normal or 275mmoll 11mgdl
Renal insufficiency creatinine clearance 40 ml per min or serum creatinine 177 µmol 2 mgdl
Anaemia hemoglobin value of 10gdl or hemoglobin 2gdl below the lower limit of normal
Bone lesions one or more osteolytic lesions on skeletal radiography CT or PET CT Any one or more of the following biomarkers of malignancy
Clonal bone marrow plasma cells percentage 60
Involved uninvolved serum-free light chain ratio 100
1 focal lesion on MRI studies It causes many organ dysfunctions and symptoms such as renal failure bony pains or fractures anemia susceptibility to infection hypercalcemia neurologic symptoms and manifestation of hyperviscosity It is characterized by the development of osteolytic lesions in the bone and involves the activation of osteoclasts with simultaneous suppression of new bone formation of osteoblast inhibition Bone pain is the most common symptom Other presentations are anemia hypercalcemia renal failure weight loss Rare features are cord compression and CNS involvement
The MM stage at presentation was documented according to the International Staging System ISS scoring and Durie-Salmon
Over the last few decades the management of MM has included chemotherapy combination regimens including VCD Velcade cyclophosphamide and dexamethasone or MP combination melphalan and prednisolone or VRD Velcade lenalidomide dexamethasone or VDT Velcade thalidomide dexamethasone or CRD Cyclophosphamide lenalidomide dexamethasone or CDT Cyclophosphamide thalidomide dexamethasone
Then Follow-up will be for the patients after receiving their treatment for at least 18 months regarding response and survival analysis and the novel therapies have significantly improved outcomes Autologous stem cell transplantation ASCT is an essential treatment strategy in the management of MM in young and fit patients
In this study we will present data of MM patients at the hematology unit in Assuit University hospitals from the year 20152025 including the demographic details clinical presentations laboratory features treatment provided response and outcomes We intended to explore the current situation of MM management including the variety of drugs used and their responses and patients undergoing ASCT and its outcome
Diagnostic criteria for Multiple Myeloma
1 Clonal bone marrow plasma cells or biopsy-proven bony or extramedullary plasmacytoma and any one of the following myeloma-defining events
2 Evidence of one or more end-organ damage that can be attributed to the underlying plasma cell proliferative disorder specifically
Hypercalcemia serum calcium 025mmoll1 mg dl higher than the upper limit of normal or 275mmoll 11mgdl
Renal insufficiency creatinine clearance 40 ml per min or serum creatinine 177 µmol 2 mgdl
Anaemia hemoglobin value of 10gdl or hemoglobin 2gdl below the lower limit of normal
Bone lesions one or more osteolytic lesions on skeletal radiography CT or PET CT Any one or more of the following biomarkers of malignancy
Clonal bone marrow plasma cells percentage 60
Involved uninvolved serum-free light chain ratio 100
1 focal lesion on MRI studies It causes many organ dysfunctions and symptoms such as renal failure bony pains or fractures anemia susceptibility to infection hypercalcemia neurologic symptoms and manifestation of hyperviscosity It is characterized by the development of osteolytic lesions in the bone and involves the activation of osteoclasts with simultaneous suppression of new bone formation of osteoblast inhibition Bone pain is the most common symptom Other presentations are anemia hypercalcemia renal failure weight loss Rare features are cord compression and CNS involvement
The MM stage at presentation was documented according to the International Staging System ISS scoring and Durie-Salmon
Over the last few decades the management of MM has included chemotherapy combination regimens including VCD Velcade cyclophosphamide and dexamethasone or MP combination melphalan and prednisolone or VRD Velcade lenalidomide dexamethasone or VDT Velcade thalidomide dexamethasone or CRD Cyclophosphamide lenalidomide dexamethasone or CDT Cyclophosphamide thalidomide dexamethasone
Then Follow-up will be for the patients after receiving their treatment for at least 18 months regarding response and survival analysis and the novel therapies have significantly improved outcomes Autologous stem cell transplantation ASCT is an essential treatment strategy in the management of MM in young and fit patients
In this study we will present data of MM patients at the hematology unit in Assuit University hospitals from the year 20152025 including the demographic details clinical presentations laboratory features treatment provided response and outcomes We intended to explore the current situation of MM management including the variety of drugs used and their responses and patients undergoing ASCT and its outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None