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NCT03169361 Clinical Trial

NINLARO Capsules Drug Use-Results Survey (All-Case Surveillance) "Relapsed/Refractory Multiple Myeloma"

Relapsed/Refractory Multiple Myeloma Clinical Trial

Official title:
NINLARO Capsules Drug Use-Results Survey (All-Case Surveillance) "Relapsed/Refractory Multiple Myeloma"

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03169361
Other study ID # C16025
Secondary ID JapicCTI-173592
Status Completed
Phase
First received
Last updated
Start date May 24, 2017
Est. completion date March 8, 2022

Study information
Verified date March 2023
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice.

Description:

The drug being tested in this study is called Ixazomib (NINLARO). Ixazomib is being tested to treat people who have relapsed/refractory multiple myeloma. This study will look at the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice. The study will enroll approximately 480 patients. • Ixazomib 4 mg This multi-center trial will be conducted in Japan.

Recruitment information / eligibility
Status Completed
Enrollment 774
Est. completion date March 8, 2022
Est. primary completion date March 8, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All patients who have been confirmed as administration of the drug. Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ixazomib
Ixazomib capsules

Locations
Country Name City State
Japan Takeda Selected Site Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants Reporting One or More Adverse Events (AEs) An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Up to 24 Week (From start of administration to the end of 6 cycles)
Primary Number of Participants Who Had One or More Adverse Drug Reactions (ADRs) An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction (ADR) refers to AE related to administered drug. Up to 24 Week (From start of administration to the end of 6 cycles)
See also
  Status Clinical Trial Phase
Recruiting NCT05427812 - Phase 1/2 Study of ISB 1442 in Relapsed/Refractory Multiple Myeloma Phase 1/Phase 2
Active, not recruiting NCT04093596 - Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL) Phase 1
Not yet recruiting NCT05498545 - Universal BCMA-targeted LUCAR-B68 Cells in Patients With Relapsed/Refractory Multiple Myeloma Phase 1
Recruiting NCT04973605 - A Phase 1b/2 Study of BGB-11417in Monotherapy and in Various Combinations With Dexamethasone and Carfilzomib in Multiple Myeloma Phase 1/Phase 2
Recruiting NCT05376345 - BCMA-targeted LCAR-BCDR Cells in Patients With Relapsed/Refractory Multiple Myeloma Phase 1
Withdrawn NCT05980507 - An Open Label, Single-arm Clinical Study Evaluating the Safety and Efficacy of ICI201 Infusion in Relapsed/Refractory Multiple Myeloma Phase 1
Active, not recruiting NCT04601935 - A Single-center Exploratory Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of a BCMA-targeted Universal LCAR-BCX Cells in Patients With Relapsed/Refractory Multiple Myeloma Phase 1
Terminated NCT06160609 - Platform Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With aOX40 (GSK3174998) in Participants With RRMM Phase 1/Phase 2
Recruiting NCT03309111 - Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma Phase 1
Recruiting NCT06049290 - A Phase I/II Clinical Trial of LBL-034 in Patients With Relapsed Refractory Multiple Myeloma Phase 1/Phase 2
Recruiting NCT05259839 - A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma Phase 1
Terminated NCT03318861 - Study to Evaluate the Safety and Efficacy of KITE-585 in Participants With Relapsed/Refractory Multiple Myeloma Phase 1
Active, not recruiting NCT03590652 - Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone as Salvage Therapy in Relapsed/Refractory Multiple Myeloma Phase 2
Completed NCT01794520 - Study Evaluating ABT-199 in Participants With Relapsed or Refractory Multiple Myeloma Phase 1/Phase 2
Terminated NCT04142619 - Study Evaluating Safety and Efficacy of UCART Targeting CS1 in Patients With Relapsed/Refractory Multiple Myeloma (MELANI-01) Phase 1
Completed NCT01849848 - Study of SyB L-0501 to Treat Relapsed/Refractory Multiple Myeloma Phase 2
Completed NCT01794507 - A Study Evaluating ABT-199 in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy Phase 1
Recruiting NCT05160584 - A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma
Terminated NCT03287908 - A Study to Assess AMG 701 Montherapy, or in Combination With Pomalidomide, With or Without, Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT03489525 - MEDI2228 in Subjects With Relapsed/Refractory Multiple Myeloma Phase 1

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