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

Primary Purpose

Newly Diagnosed Multiple Myeloma

Status

Withdrawn

Phase

Phase 4

Locations

Iraq

Study Type

Interventional

Intervention

Bortezomib 3.5 MG

About this trial

This is an interventional treatment trial for Newly Diagnosed Multiple Myeloma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Baghdad Hematology center - Baghdad Medical City

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Induction Therapy

Arm Description

Bortezomib will be administered as part of VCD or VRD protocols

Outcomes

Primary Outcome Measures

Assessment the safety of Alvocade® therapy

Monitoring the rate of any adverse effect/event that will occur during the induction therapy

Assessment the effecacy of Alvocade® therapy

Assessment of overall response rate (ORR) of treatment after completion of induction protocol

Secondary Outcome Measures

First assessment response

Assessment of response rate after 2 cycle from starting treatment protocol

Second assessment response

Assessment of response rate after 4 cycle from starting treatment protocol

Third assessment response

Third assessment response after 6th cycle protocol (if there is no response or get less than VGPR after 4th cycle)

Full Information

NCT ID

NCT04348006

First Posted

April 13, 2020

Last Updated

April 26, 2023

Sponsor

Al-Rasheed University College

Collaborators

Baghdad Medical City

1. Study Identification

Unique Protocol Identification Number

NCT04348006

Brief Title

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

Acronym

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Withdrawn

Why Stopped

No patients were enrolled in the study

Study Start Date

March 1, 2020 (Actual)

Primary Completion Date

July 30, 2021 (Anticipated)

Study Completion Date

July 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Al-Rasheed University College

Collaborators

Baghdad Medical City

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Newly Diagnosed Multiple Myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Induction Therapy

Arm Type

Experimental

Arm Description

Bortezomib will be administered as part of VCD or VRD protocols

Intervention Type

Drug

Intervention Name(s)

Bortezomib 3.5 MG

Other Intervention Name(s)

Cyclophosphamide, Dexamethasone, lenalidomide

Intervention Description

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)

Primary Outcome Measure Information:

Title

Assessment the safety of Alvocade® therapy

Description

Monitoring the rate of any adverse effect/event that will occur during the induction therapy

Time Frame

During 6 months

Title

Assessment the effecacy of Alvocade® therapy

Description

Assessment of overall response rate (ORR) of treatment after completion of induction protocol

Time Frame

At end of 6 months

Secondary Outcome Measure Information:

Title

First assessment response

Description

Assessment of response rate after 2 cycle from starting treatment protocol

Time Frame

At end of 2 months

Title

Second assessment response

Description

Assessment of response rate after 4 cycle from starting treatment protocol

Time Frame

At end of 4 months

Title

Third assessment response

Description

Third assessment response after 6th cycle protocol (if there is no response or get less than VGPR after 4th cycle)

Time Frame

At end of 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: