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

Sponsor
Al-Rasheed University College (Other)
Overall Status
Unknown status
CT.gov ID
NCT04348006
Collaborator
Baghdad Medical City (Other)
30
Enrollment
1
Location
1
Arm
17
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Bortezomib 3.5 MG
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Assessment of Bortezomib (Alvocade ®) Efficacy and Safety in Newly Diagnosed Multiple Myeloma Patients
Actual Study Start Date :
Mar 1, 2020
Anticipated Primary Completion Date :
Jul 30, 2021
Anticipated Study Completion Date :
Jul 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Induction Therapy

Bortezomib will be administered as part of VCD or VRD protocols

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)
Other Names:
  • Cyclophosphamide
  • Dexamethasone
  • lenalidomide

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assessment the safety of Alvocade® therapy [During 6 months]

      Monitoring the rate of any adverse effect/event that will occur during the induction therapy

    2. Assessment the effecacy of Alvocade® therapy [At end of 6 months]

      Assessment of overall response rate (ORR) of treatment after completion of induction protocol

    Secondary Outcome Measures

    1. First assessment response [At end of 2 months]

      Assessment of response rate after 2 cycle from starting treatment protocol

    2. Second assessment response [At end of 4 months]

      Assessment of response rate after 4 cycle from starting treatment protocol

    3. Third assessment response [At end of 6 months]

      Third assessment response after 6th cycle protocol (if there is no response or get less than VGPR after 4th cycle)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Newly diagnosis Multiple myeloma with CRAB (C: hypercalcemia, R: renal impairment, A: anemia, and B: bone lesions)

    • Age above 18 years old

    Exclusion Criteria:

    • Age below 18 years

    • Smoldering MM

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baghdad Hematology center - Baghdad Medical City Baghdad Bab-Almuadham Iraq 12221

    Sponsors and Collaborators

    • Al-Rasheed University College
    • Baghdad Medical City

    Investigators

    • Principal Investigator: Ali M Jawad, PhD, Baghdad College of Medicine
    • Principal Investigator: Bassam F Matti, PhD, Baghdad Medical City
    • Study Chair: Tareq A Saleh, PhD, Baghdad Medical City
    • Study Director: Mahammed S Abbas, PhD, Baghdad Medical City
    • Principal Investigator: Mohammed K Al-Qayyim, PhD, Baghdad Medical City
    • Principal Investigator: Alaaldin S Naji, PhD, Baghdad College of Medicine
    • Principal Investigator: Ammer F Majid, PhD, Baghdad Medical City
    • Principal Investigator: Adil S Al-Oqaby, PhD, Baghdad Medical City
    • Principal Investigator: Mazin A Shubir, PhD, Baghdad Medical City
    • Principal Investigator: Hawraa D Jumaa, PhD, Baghdad Medical City
    • Principal Investigator: Hayder A Fawzi, PhD, Al-Rasheed University College

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Al-Rasheed University College
    ClinicalTrials.gov Identifier:
    NCT04348006
    Other Study ID Numbers:
    • AR200103
    • SEANM
    First Posted:
    Apr 15, 2020
    Last Update Posted:
    Apr 15, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Dexamethasone
    Cyclophosphamide
    Lenalidomide
    Bortezomib

    Study Results

    No Results Posted as of Apr 15, 2020