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

NCT04348006 | Withdrawn Phase 4 DMC

• 2 other identifiers: AR200103SEANM
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• First assessment response

  At end of 2 months

• Second assessment response

  At end of 4 months

• Third assessment response

  At end of 6 months

Study Arms (1)

Induction Therapy

EXPERIMENTAL

Bortezomib will be administered as part of VCD or VRD protocols

Drug: Bortezomib 3.5 MG

Interventions

Bortezomib 3.5 MG DRUG

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)

Also known as: Cyclophosphamide, Dexamethasone, lenalidomide

Induction Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosis Multiple myeloma with CRAB (C: hypercalcemia, R: renal impairment, A: anemia, and B: bone lesions)
• Age above 18 years old

You may not qualify if:

• Age below 18 years
• Smoldering MM

Sponsors & Collaborators

• Al-Rasheed University College: lead
• Baghdad Medical City: collaborator

Study Sites (1)

Baghdad Hematology center - Baghdad Medical City

Baghdad, Bab-Almuadham, 12221, Iraq

Location

MeSH Terms

Interventions

Bortezomib; Cyclophosphamide; Dexamethasone; Lenalidomide

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ali M Jawad, PhD

  University of Baghdad

  PRINCIPAL INVESTIGATOR

• Bassam F Matti, PhD

  Baghdad Medical City

  PRINCIPAL INVESTIGATOR

• Tareq A Saleh, PhD

  Baghdad Medical City

  STUDY CHAIR

• Mahammed S Abbas, PhD

  Baghdad Medical City

  STUDY DIRECTOR

• Mohammed K Al-Qayyim, PhD

  Baghdad Medical City

  PRINCIPAL INVESTIGATOR

• Alaaldin S Naji, PhD

  University of Baghdad

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 15, 2020
• Study Start: March 1, 2020
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

IR (1)