A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma

Relapsed/Refractory Multiple Myeloma Clinical Trial

— MoMMent  

Official title:

A Prospective, Multinational Study of Real-Life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05160584
• Other study ID #: CR109118
• Secondary ID: 64407564MMY4001
• Status: Recruiting
• 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
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2026
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic criteria

• Received at least 3 prior lines of therapy (induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen). Undergone at least 1 complete cycle of treatment for each line of therapy, unless progressive disease (PD) was the best response to the line of therapy

• Have an Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1

• Must not be pregnant or must not plan to become pregnant within the study period

• Must have documented evidence of progressive disease based on participating physician's determination of response by the IMWG response criteria on or after the last regimen. Participants with documented evidence of progressive disease within the previous 6 months and who are refractory or non-responsive to their most recent line of treatment afterwards are also eligible

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed/Refractory Multiple Myeloma

Intervention

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

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
Belgium	Ucl de Mont-Godinne	Yvoir
France	CHRU de Lille Hopital Claude Huriez	Lille
France	CHU de Montpellier, Hopital Saint-Eloi	Montpellier Cedex 5
France	CHU de Nantes hotel Dieu	Nantes Cedex 1
France	Centre hospitalier Lyon-Sud	Pierre-Bénite
France	Pôle IUC Oncopole CHU	Toulouse cedex 9
Germany	Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin	Berin
Germany	Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden	Dresden
Germany	Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik	Hamburg
Germany	Universitaetsklinikum Heidelberg	Heidelberg
Germany	Universitaetsklinikum Koeln	Koeln
Germany	Universitaetsklinikum Leipzig	Leipzig
Germany	Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany	Tubingen
Germany	Universitatsklinikum Wurzburg	Wuerzburg
Italy	U.O. Ematologia Istituto Tumori Giovanni Paolo II	Bari
Italy	Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi	Bologna
Italy	Policlinico di Catania	Catania
Italy	IRCCS Azienda Ospedaliera San Martino - IST	Genova
Italy	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori	Meldola
Italy	Universita degli Studi di Padova Azienda Ospedaliera di Pa	Padova
Italy	Ospedale Villa Sofia-Cervello	Palermo
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	Fondazione Policlinico Universitario A Gemelli IRCCS	Roma
Italy	Università di Roma La Sapienza	Roma
Italy	IRCCS Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo
Italy	Ospedale Cardinale G. Panico	Tricase
Netherlands	VU Medisch Centrum	Amsterdam
Netherlands	UMCG	Groningen
Spain	Inst. Cat. Doncologia-H Duran I Reynals	Barcelona
Spain	Hosp. de Cabuenes	Gijón
Spain	Hosp. de Jerez de La Frontera	Jerez de la Frontera
Spain	Hosp. de Leon	Leon
Spain	Hosp. Univ. 12 de Octubre	Madrid
Spain	Hosp. Univ. Ramon Y Cajal	Madrid
Spain	Hosp. Univ. Son Espases	Palma
Spain	Clinica Univ. de Navarra	Pamplona
Spain	Hosp Clinico Univ de Salamanca	Salamanca
Spain	Hosp. Univ. Marques de Valdecilla	Santander
Spain	Hosp. Clinico Univ. de Santiago	Santiago de Compostela
Spain	Hosp. Clinico Univ. de Valladolid	Valladolid
United Kingdom	Southmead Hospital	Bristol
United Kingdom	King s College Hospital	London
United Kingdom	St George's Hospital	London
United Kingdom	University College Hospital	London
United Kingdom	Maidstone Hospital	Maidstone
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	The Royal Marsden NHS Trust Sutton	Surrey

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