Clinical Outcomes and Prognostic Factors in Multiple Myeloma Patients

Assiut University

Status

Not yet enrolling

Conditions

Multiple Myeloma

Treatments

Drug: Chemotherapy

Study type

Observational

Funder types

Other

Identifiers

NCT06457464

COPFPMM

Details and patient eligibility

About

Description of the demographic, clinical, and laboratory characteristics of patients with MM admitted to the hematology unit of Assuit University Hospitals.
Determination of treatment outcomes and prognostic factors associated with survival rates.

Full 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:

Clonal bone marrow plasma cells or biopsy-proven bony or extramedullary plasmacytoma and any one of the following myeloma-defining events.
Evidence of one or more end-organ damage that can be attributed to the underlying plasma cell proliferative disorder specifically:
- Hypercalcemia: serum calcium > 0.25mmol/l(>1 mg /dl) higher than the upper limit of normal or > 2.75mmol/l (>11mg/dl).
- Renal insufficiency: creatinine clearance <40 ml per min or serum creatinine >177 µmol (>2 mg/dl) .
- Anaemia : (hemoglobin value of < 10g/dl or hemoglobin > 2g/dl 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 {2015:2025} 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients ≥ 18 years old diagnostic as MM with Eastern Cooperative Oncology Group performance status(ECOG) Performance Status (0-2)

Exclusion criteria

Patients with poor performing status unfit to receive chemotherapy with ECOG PS > 2