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Assessment of Bortezomib (Alvocade ®) Efficacy and Safety in Newly Diagnosed Multiple Myeloma Patients

NCT04348006 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2023-04-28

No results posted yet for this study

Summary

Bortezomib considered the standard of care for treating multiple myeloma patients, the aim was to assess the safety and efficacy of newly approved drug (Alvocade ®) in Iraq, in newly diagnosed patients.

Conditions

  • Newly Diagnosed Multiple Myeloma

Interventions

DRUG

Bortezomib 3.5 MG

VCD protocol * V, Alvocade®: Day 1, 4, 8, 11 (1.3 mg/m2 SC) * C, Cyclophosphamide: 300 mg/m2 IV over 30 min (day 1, 8, 15) * D, Dexamethasone oral: 40mg (days 1 to 4) VRD protocol: * V, Alvocade®: Day 1, 4, 8, 11 (1.3 mg/m2 SC) * R, Lenalid® cap 25 mg po (day 1 to 21) * D, Dexamethasone oral: 40mg (days 1 to 4)

Sponsors & Collaborators

  • Baghdad Medical City

    collaborator OTHER

  • Al-Rasheed University College

    lead OTHER

Principal Investigators

  • Ali M Jawad, PhD · Baghdad college of medicine

  • Bassam F Matti, PhD · Baghdad Medical City

  • Tareq A Saleh, PhD · Baghdad Medical City

  • Mahammed S Abbas, PhD · Baghdad Medical City

  • Mohammed K Al-Qayyim, PhD · Baghdad Medical City

  • Alaaldin S Naji, PhD · Baghdad college of medicine

  • Ammer F Majid, PhD · Baghdad Medical City

  • Adil S Al-Oqaby, PhD · Baghdad Medical City

  • Mazin A Shubir, PhD · Baghdad Medical City

  • Hawraa D Jumaa, PhD · Baghdad Medical City

  • Hayder A Fawzi, PhD · Al-Rasheed University College

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2021-07-30
Completion
2021-07-30

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04348006 on ClinicalTrials.gov