A Study of Real-life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma Who Received at Least 3 Prior Lines of Therapy Including Proteasome Inhibitor (PI), Immunomodulatory Drug (IMID), and Cluster of Differentiation 38 (CD38) Monoclonal Antibody Treatment

Multiple Myeloma Clinical Trial

— LocoMMotion  

Official title:

A Prospective, Multinational Study of Real-life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma Who Received at Least 3 Prior Lines of Therapy Including PI, IMID, and CD38 Monoclonal Antibody Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04035226
• Other study ID #: CR108651
• Secondary ID: 68284528MMY4001
• Status: Completed
• Start date: August 2, 2019
• Est. completion date: October 27, 2022

Study information

• Verified date: December 2023
• Source: Janssen-Cilag Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess the safety and clinical response including overall response rate (ORR) of real-life standard-of-care (SOC) treatments under routine clinical practice, over a 24-month period, in patients with relapsed/refractory multiple myeloma (RRMM).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: October 27, 2022
• Est. primary completion date: October 27, 2022
• 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 or are double refractory to a proteasome inhibitor (PI) and an immunomodulatory agent (IMID) (induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen). Patients will have undergone at least 1 complete cycle of treatment for each regimen (unless progressive disease was the best response)
• Must have documented evidence of progressive disease based on study physician's determination of response by the IMWG response criteria on or after the last regimen. Patients with documented evidence of progressive disease within the previous 6 months and who are refractory or nonresponsive to their most recent line of treatment afterwards are also eligible
• 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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• No intervention
No intervention will be administered as a part of this study.

Locations

Country	Name	City	State
Belgium	Grand Hopital de Charleroi, site Notre Dame	Charleroi
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	UZ Leuven	Leuven
Belgium	Ucl de Mont-Godinne	Yvoir
France	Centre Hospitalier du Mans	Le Mans
France	Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez	Lille Cedex
France	CHU de Montpellier, Hopital Saint-Eloi	Montpellier
France	C.H.U. Hotel Dieu - France	Nantes
France	Hopital Saint-Louis	Paris cedex 10
France	Hopital Saint-Antoine	PARIS cedex 12
France	Centre hospitalier Lyon-Sud	Pierre-Bénite
France	CHU Poitiers - Hôpital la Milétrie	Poitiers
France	Pôle IUC Oncopole CHU	Toulouse cedex 9
Germany	Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik	Hamburg
Germany	Universitaetsklinikum Heidelberg	Heidelberg
Germany	Universitaetsklinikum Koelnt	Koeln
Germany	Medizinische Klinik A	Muenster
Germany	Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany	Tübingen
Germany	Universitätsklinikum Würzburg	Würzburg
Italy	U.O. Ematologia con Trapianto- AOU Policlinico di Bari	Bari
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	Azienda Ospedaliera Universitaria Careggi	Firenze
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	Irccs Crob	Rionero in Vulture
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
Italy	A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette	Turin
Netherlands	VU Medisch Centrum	Amsterdam
Netherlands	UMCG	Groningen
Netherlands	Erasmus MC - Satellite	Rotterdam
Poland	Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie	Lublin
Poland	Szpital Kliniczny im. H. Swiecickiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Poznaniu	Poznan
Russian Federation	S.P. Botkin Moscow City Clinical Hospital	Moscow
Russian Federation	Samara Region Clinical Hospital	Samara
Russian Federation	Clinical Research Institute of Hematology and Transfusiology	St-Petersburg
Spain	Inst. Cat. Doncologia-H Duran I Reynals	Barcelona
Spain	Hosp. Puerta Del Mar	Cadiz
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. Mutua Terrassa	Terrassa
Spain	Hosp. Univ. Dr. Peset	Valencia
Spain	Hosp. Clinico Univ. de Valladolid	Valladolid
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United Kingdom	Southmead Hospital	Bristol
United Kingdom	Maidstone Hospital	Kent
United Kingdom	King's College Hospital	London
United Kingdom	St George's Hospital	London
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	The Royal Marsden NHS Trust Sutton	Surrey
United States	Central Care Cancer Center	Bolivar	Missouri
United States	The Ohio State University	Columbus	Ohio
United States	The Cancer Institute at St. Francis Hospital	East Hills	New York
United States	North Shore Hematology Oncology Associates, P.C.	East Setauket	New York
United States	Hunterdon Hematology Oncology	Flemington	New Jersey
United States	Oncology Institute of Hope and Innovation	Glendale	California
United States	Marin Cancer Center	Greenbrae	California
United States	Optum Care	Las Vegas	Nevada
United States	Oncology Hematology Assoc of Central Illinois, P.C. d.b.a. Illinois CancerCare, P.C.	Peoria	Illinois
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Providence Cancer Center	Southfield	Michigan
United States	Asclepes Research	Weeki Wachee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Janssen-Cilag Ltd.	Legend Biotech

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Italy,  Netherlands,  Poland,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	ORR is defined as the percentage of patients who achieve a partial response (PR) or better according to the international myeloma working group (IMWG) response criteria.	Up to 24 months
Secondary	Very Good Partial Response (VGPR) Rate	VGPR rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria.	Up to 24 months
Secondary	Complete Response (CR) Rate	CR rate is defined as the percentage of patients who achieve a complete response (CR) or better according to IMWG response criteria.	Up to 24 months
Secondary	Stringent Complete Response (sCR) Rate	sCR rate is defined as the percentage of patients who achieve a stringent complete response (sCR) according to IMWG response criteria.	Up to 24 months
Secondary	Minimal Residual Disease (MRD) Negative Rate	Minimal residual disease (MRD) negative rate is defined as the percentage of patients with negative MRD status according to IMWG response criteria.	Up to 24 months
Secondary	Clinical Benefit Rate (CBR)	CBR is defined as the percentage of patients with clinical benefit. CBR = ORR (sCR + CR + VGPR + PR) + minimal response (MR).	Up to 24 months
Secondary	Duration of Response	Duration of response 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 (according to IMWG criteria).	Up to 24 months
Secondary	Time to Response	Time to response is defined as the time between the date of Day 1 of Cycle 1 and the first clinical response evaluation that the patient has met all criteria for PR or better response.	Up to 24 months
Secondary	Time to Next Treatment [TTNT]	Time to next treatment is defined as the time from diagnosis to the start of the next-line treatment.	Up to 24 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 (according to IMWG response criteria) or death due to any cause, whichever occurs first.	Up to 24 months
Secondary	Time to Progression on the Next Line of Subsequent Antimyeloma Therapy or Death (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 24 months
Secondary	Overall Survival (OS)	Overall survival is the duration from the date of Day 1 of Cycle 1 to the date of the patient's death or study completion, whichever occurs first.	Up to 24 months
Secondary	Change from Baseline in Health-related Quality of Life (HRQoL) using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Scale Score	The EORTC QLQ-C30 version 3 includes 30 items in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single symptom items. The responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater health-related quality-of-life (HRQoL), better functioning, and more (worse) symptoms.	Baseline up to 24 months
Secondary	Change from Baseline in Health-related Quality of Life (HRQoL) using European Organization for Research and Treatment of Cancer (EORTC) QLQ-MY20 Scale Score	The EORTC QLQ-MY20 was designed to use alongside the EORTC QLQ-C30 to address issues of more relevance to myeloma patients. Four single items from the EORTC QLQ-MY20 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 24 months
Secondary	Change from Baseline in Health-related Quality of Life (HRQoL) using EQ-5D-5L Questionnaire Score	EuroQol Five Dimension (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 24 months
Secondary	Number of Patients with Adverse Events (AEs)	An AE is any untoward medical occurrence in a patient participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	Up to 24 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 24 months