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

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.

Study Overview

• Status: Withdrawn
• Conditions: Newly Diagnosed Multiple Myeloma
• Intervention / Treatment: Drug: Bortezomib 3.5 MG

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Tareq A Saleh, PhD; Phone Number: 964 07738293183; Email: tariqyamanmed@yahoo.com
• Study Contact Backup: Name: Hayder A Fawzi, PhD; Phone Number: +964 07722629743; Email: hayder.adnan2010@gmail.com

Study Locations

• Iraq
  • Bab-Almuadham
    • Baghdad, Bab-Almuadham, Iraq, 12221
      • Baghdad Hematology center - Baghdad Medical City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: Dexamethasone; Cyclophosphamide; lenalidomide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment the safety of Alvocade® therapy	Monitoring the rate of any adverse effect/event that will occur during the induction therapy	During 6 months
Assessment the effecacy of Alvocade® therapy	Assessment of overall response rate (ORR) of treatment after completion of induction protocol	At end of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First assessment response	Assessment of response rate after 2 cycle from starting treatment protocol	At end of 2 months
Second assessment response	Assessment of response rate after 4 cycle from starting treatment protocol	At end of 4 months
Third assessment response	Third assessment response after 6th cycle protocol (if there is no response or get less than VGPR after 4th cycle)	At end of 6 months

Collaborators and Investigators

• Sponsor: Al-Rasheed University College
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Anticipated): July 30, 2021
• Study Completion (Anticipated): July 30, 2021

Study Registration Dates

• First Submitted: April 13, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Dexamethasone; Cyclophosphamide; Lenalidomide; Bortezomib
• Other Study ID Numbers: AR200103; SEANM (Registry Identifier: Baghdad Hematology Center Ethical committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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