Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05160584
Other study ID # CR109118
Secondary ID 64407564MMY4001
Status Recruiting
Phase
First received
Last updated
Start date November 18, 2021
Est. completion date December 31, 2026

Study information

Verified date June 2024
Source Janssen Pharmaceutica N.V., Belgium
Contact Study Contact
Phone 844-434-4210
Email Participate-In-This-Study@its.jnj.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to assess in real-life clinical practice, over a 24-month period, the effectiveness and safety of current standard of care (SOC) antimyeloma treatments in participants with previously treated relapsed and/or refractory multiple myeloma.


Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
There is no interventional treatment component for participants with RRMM in this study.

See more »

Sponsors (1)

Lead Sponsor Collaborator
Janssen Pharmaceutica N.V., Belgium

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Response Rate (ORR) Overall Response Rate is defined as the percentage of participants who achieve a partial response (PR) or better response according to the International Myeloma Working Group (IMWG) response criteria, as assessed by Response Review Committee (RRC). Up to 35 months
Secondary Very Good Partial Response (VGPR) Rate VGPR rate is defined as the percentage of participants who achieve a VGPR or better response according to IMWG response criteria. Up to 35 months
Secondary Complete Response (CR) Rate CR rate is defined as the percentage of participants who achieve a CR or better response according to IMWG response criteria. Up to 35 months
Secondary Stringent Complete Response (sCR) Rate sCR rate is defined as the percentage of participants who achieve a sCR according to IMWG response criteria. Up to 35 months
Secondary Minimal Residual Disease (MRD) Negative Rate MRD negative rate is defined as the percentage of participants with negative MRD status according to IMWG response criteria. Up to 35 months
Secondary Clinical Benefit Rate (CBR) CBR is defined as the percentage of participants with clinical benefit. CBR=ORR (sCR + CR + VGPR + PR) + minimal response (MR). Up to 35 months
Secondary Duration of Response (DOR) DOR is defined as time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease as defined in the IMWG criteria. Up to 35 months
Secondary Time to Response (TTR) TTR is defined as the time between the date of Day 1 of Cycle 1 and the first clinical response evaluation that the participant has met all criteria for PR or better response. Up to 35 months
Secondary Time to Best Response Time to best response is defined as the time between the date of Day 1 of Cycle 1 and best objective response. Up to 35 months
Secondary Time to Next Treatment (TTNT) TTNT is defined as the time from diagnosis to the start of the next-line treatment. Up to 35 months
Secondary Progression-free Survival (PFS) PFS is defined as the time from the date of Day 1 of Cycle 1 to the date of first documented disease progression (as defined in the IMWG response criteria) or death due to any cause, whichever occurs first. Up to 35 months
Secondary Time to Progression on the Next Line of Subsequent Antimyeloma Therapy or Death, Whichever Occurs First (PFS2) PFS2 is defined as the time from the date of Day 1 of Cycle 1 to progression on the next line of subsequent antimyeloma therapy or death, whichever occurs first. Up to 35 months
Secondary Overall Survival (OS) OS is the duration from the date of Day 1 of Cycle 1 to the date of the participant's death or study completion, whichever occurs first. Up to 35 months
Secondary Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score The EORTC-QLQ-C30 Version 3 includes 30 items in 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. Baseline up to 35 months
Secondary Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L) The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). Baseline up to 35 months
Secondary Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EORTC QLQ-IL39 EORTC QLQ-IL39 (four single items from the EORTC QLQMY20) will be performed to assess emotional health status (feel restless or agitated, thinking about your illness, worried about dying, worried about health in the future) on scale of 1 (not at all) to 4 (very much). Baseline up to 35 months
Secondary Number of Participants with Adverse Events (AEs) An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Up to 35 months
Secondary Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Severity of AEs has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death related to adverse event. Up to 35 months
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
Completed 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
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
Recruiting NCT05862012 - Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma Phase 1
Completed NCT03489525 - MEDI2228 in Subjects With Relapsed/Refractory Multiple Myeloma Phase 1