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

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ClinicalTrials.gov Identifier: NCT04348006
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : April 15, 2020
Sponsor:
Collaborator:
Baghdad Medical City
Information provided by (Responsible Party):
Al-Rasheed University College

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
Newly Diagnosed Multiple Myeloma Drug: Bortezomib 3.5 MG Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 1, 2020
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Bortezomib

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




Primary Outcome Measures :
  1. Assessment the safety of Alvocade® therapy [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At end of 2 months ]
    Assessment of response rate after 2 cycle from starting treatment protocol

  2. Second assessment response [ Time Frame: At end of 4 months ]
    Assessment of response rate after 4 cycle from starting treatment protocol

  3. Third assessment response [ Time Frame: 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)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04348006


Contacts
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Contact: Tareq A Saleh, PhD 07738293183 ext 964 tariqyamanmed@yahoo.com
Contact: Hayder A Fawzi, PhD 07722629743 ext +964 hayder.adnan2010@gmail.com

Locations
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Iraq
Baghdad Hematology center - Baghdad Medical City Recruiting
Baghdad, Bab-Almuadham, Iraq, 12221
Contact: Tareq A Saleh, PhD    07738293183 ext 964    tariqyamanmed@yahoo.com   
Contact: Bassam F Matti, PhD    07702052345 ext 964    bassam_francis@yahoo.com   
Principal Investigator: Tareq A Saleh, PhD         
Principal Investigator: Bassam F Matti, PhD         
Sub-Investigator: Mohammed K Al-Qayyim, PhD         
Principal Investigator: Mahammed S Abbas, PhD         
Principal Investigator: Alaaldin S Naji, PhD         
Principal Investigator: Ammer F Majid, PhD         
Principal Investigator: Adil S Al-Oqaby, PhD         
Principal Investigator: Mazin A Shubir, PhD         
Sub-Investigator: Hawraa D Jumaa, PhD         
Principal Investigator: Ali M Jawad, PhD         
Sponsors and Collaborators
Al-Rasheed University College
Baghdad Medical City
Investigators
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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
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Responsible Party: Al-Rasheed University College
ClinicalTrials.gov Identifier: NCT04348006    
Other Study ID Numbers: AR200103
SEANM ( Registry Identifier: Baghdad Hematology Center Ethical committee )
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Cyclophosphamide
Lenalidomide
Bortezomib
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents