Clinical Outcomes and Prognostic Factors in Multiple Myeloma Patients

NCT06457464 | Not Yet Recruiting

• 1 other identifier: COPFPMM
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• variety of drugs used and their responses, and pateints

  examine the current state of multiple myeloma management, including the variety of drugs used and their effectiveness, as well as the outcomes for patients undergoing autologous stem cell transplantation (ASCT).

  baseline

Interventions

Chemotherapy DRUG

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Sample size was calculated using Epi- Info7. According to results of previous study. Based on this percentage, confidence limits of 5% and a confidence level of 90%, the sample needed for the study was estimated to be about 97 patients.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Kyle RA, Gertz MA, Witzig TE, Lust JA, Lacy MQ, Dispenzieri A, Fonseca R, Rajkumar SV, Offord JR, Larson DR, Plevak ME, Therneau TM, Greipp PR. Review of 1027 patients with newly diagnosed multiple myeloma. Mayo Clin Proc. 2003 Jan;78(1):21-33. doi: 10.4065/78.1.21.

  PMID: 12528874 BACKGROUND

• Shin J, Koh Y, Youk J, Kim M, Kim BS, Choi CW, Sung HJ, Park Y, Yoon SS, Kim I. Clinicopathological characteristics of extremely young Korean multiple myeloma patients: therapeutic implications. Korean J Intern Med. 2017 Jul;32(4):722-730. doi: 10.3904/kjim.2016.256. Epub 2017 Jun 26.

  PMID: 28651310 BACKGROUND

• Greipp PR, San Miguel J, Durie BG, Crowley JJ, Barlogie B, Blade J, Boccadoro M, Child JA, Avet-Loiseau H, Kyle RA, Lahuerta JJ, Ludwig H, Morgan G, Powles R, Shimizu K, Shustik C, Sonneveld P, Tosi P, Turesson I, Westin J. International staging system for multiple myeloma. J Clin Oncol. 2005 May 20;23(15):3412-20. doi: 10.1200/JCO.2005.04.242. Epub 2005 Apr 4.

  PMID: 15809451 BACKGROUND

• Richardson PG, Hideshima T, Anderson KC. Bortezomib (PS-341): a novel, first-in-class proteasome inhibitor for the treatment of multiple myeloma and other cancers. Cancer Control. 2003 Sep-Oct;10(5):361-9. doi: 10.1177/107327480301000502.

  PMID: 14581890 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 8, 2024
• First Posted: June 13, 2024
• Study Start: July 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06