Newly Diagnosed Multiple MyelomaPhase 4MMNCT04348006
Assessment of Bortezomib (Alvocade ®) Efficacy and Safety in Newly Diagnosed Multiple Myeloma Patients
A Phase 4 study testing Bortezomib 3.5 MG in people with Newly Diagnosed Multiple Myeloma, run by Al-Rasheed University College at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Newly Diagnosed Multiple Myeloma
- What is being tested?
- Bortezomib 3.5 MG
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIraq
- Study dates
- 1 Mar 2020to 30 Jul 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosis Multiple myeloma with CRAB (C: hypercalcemia, R: renal impairment, A: anemia, and B: bone lesions)
- Age above 18 years old
Who cannot join
- Age below 18 years
- Smoldering MM
Trial locations and contacts
1 site in 1 country.
Iraq1 site
Baghdad Hematology center - Baghdad Medical City
Baghdad, Bab-Almuadham, 12221
About this study
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
- Being tested
- Bortezomib 3.5 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bortezomib 3.5 MGDrug
Also called Cyclophosphamide, Dexamethasone, lenalidomide
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)
| Study group | Role | What they receive |
|---|---|---|
| Induction Therapy | Experimental | Bortezomib will be administered as part of VCD or VRD protocols Receives: Drug: Bortezomib 3.5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment the safety of Alvocade® therapy
Monitoring the rate of any adverse effect/event that will occur during the induction therapy
Measured: During 6 months
Assessment the effecacy of Alvocade® therapy
Assessment of overall response rate (ORR) of treatment after completion of induction protocol
Measured: At end of 6 months
Secondary outcomes (3)
First assessment response
Assessment of response rate after 2 cycle from starting treatment protocol
Measured: At end of 2 months
Second assessment response
Assessment of response rate after 4 cycle from starting treatment protocol
Measured: 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)
Measured: At end of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start1 Mar 2020
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Why it stopped: No patients were enrolled in the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Rasheed University College
- Sponsor type
- University, hospital or other
- Collaborators
- Baghdad Medical City
- Responsible party
- Sponsor
- Investigators
- Ali M Jawad, PhD, Principal investigator, University of BaghdadBassam F Matti, PhD, Principal investigator, Baghdad Medical CityTareq A Saleh, PhD, Study chair, Baghdad Medical CityMahammed S Abbas, PhD, Study director, Baghdad Medical CityMohammed K Al-Qayyim, PhD, Principal investigator, Baghdad Medical CityAlaaldin S Naji, PhD, Principal investigator, University of BaghdadAmmer F Majid, PhD, Principal investigator, Baghdad Medical CityAdil S Al-Oqaby, PhD, Principal investigator, Baghdad Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348006
- Sponsor's protocol ID
- AR200103
- Other IDs
- SEANM
- Acronym
- MM
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2020
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bortezomib (Alvocade ®) Efficacy and Safety in Newly Diagnosed Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT04348006
- Acronym / sponsor ID
- MM / AR200103
- Conditions
- Newly Diagnosed Multiple Myeloma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients were enrolled in the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Al-Rasheed University CollegeUniversity, hospital or other
- Collaborators
- Baghdad Medical City
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Induction Therapy | Experimental | Drug: Bortezomib 3.5 MGBortezomib will be administered as part of VCD or VRD protocols |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Newly diagnosis Multiple myeloma with CRAB (C: hypercalcemia, R: renal impairment, A: anemia, and B: bone lesions)
- Age above 18 years old
Key exclusion criteria (2 listed)
- Age below 18 years
- Smoldering MM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bortezomib 3.5 MGAlso: Cyclophosphamide, Dexamethasone, lenalidomideVCD 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) | Drug | Induction Therapy |
Primary outcome
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
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
3 secondary outcomes
First assessment response
Time frame: At end of 2 months
Second assessment response
Time frame: At end of 4 months
Third assessment response
Time frame: At end of 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali M Jawad, PhD principal investigator
University of Baghdad
Bassam F Matti, PhD principal investigator
Baghdad Medical City
Tareq A Saleh, PhD study chair
Baghdad Medical City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bortezomib 3.5 MG in people with Newly Diagnosed Multiple Myeloma, run by Al-Rasheed University College at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment the safety of Alvocade® therapy (time frame: During 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.