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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04348006
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Al-Rasheed University College
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ali M Jawad, PhDBassam F Matti, PhDTareq A Saleh, PhDMahammed S Abbas, PhDMohammed K Al-Qayyim, PhDAlaaldin S Naji, PhDAmmer F Majid, PhDAdil S Al-Oqaby, PhDMazin A Shubir, PhDHawraa D Jumaa, PhDHayder A Fawzi, PhD
Principal Investigator Affiliation Baghdad College of MedicineBaghdad Medical CityBaghdad Medical CityBaghdad Medical CityBaghdad Medical CityBaghdad College of MedicineBaghdad Medical CityBaghdad Medical CityBaghdad Medical CityBaghdad Medical CityAl-Rasheed University College
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Recruiting
Countries Iraq
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Newly Diagnosed Multiple Myeloma
Arms & Interventions

Arms

Experimental: Induction Therapy

Bortezomib will be administered as part of VCD or VRD protocols

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Baghdad, Bab-Almuadham, Iraq

Status

Recruiting

Address

Baghdad Hematology center - Baghdad Medical City

Baghdad, Bab-Almuadham, 12221

Site Contact

Tareq A Saleh, PhD

tariqyamanmed@yahoo.com

07738293183 #964