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
- Conditions
- Multiple Myeloma
- Interventions
- Other: No intervention
- Registration Number
- NCT04035226
- Lead Sponsor
- Janssen-Cilag Ltd.
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 254
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Relapsed/refractory Multiple Myeloma No intervention Patients with relapsed/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 will be observed.
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR) Up to 24 months 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.
- Secondary Outcome Measures
Name Time Method Time to Next Treatment [TTNT] Up to 24 months Time to next treatment is defined as the time from diagnosis to the start of the next-line treatment.
Complete Response (CR) Rate Up to 24 months CR rate is defined as the percentage of patients who achieve a complete response (CR) or better according to IMWG response criteria.
Minimal Residual Disease (MRD) Negative Rate Up to 24 months Minimal residual disease (MRD) negative rate is defined as the percentage of patients with negative MRD status according to IMWG response criteria.
Clinical Benefit Rate (CBR) Up to 24 months CBR is defined as the percentage of patients with clinical benefit. CBR = ORR (sCR + CR + VGPR + PR) + minimal response (MR).
Time to Response Up to 24 months 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.
Duration of Response Up to 24 months 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).
Time to Progression on the Next Line of Subsequent Antimyeloma Therapy or Death (PFS2) Up to 24 months 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.
Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Up to 24 months 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.
Stringent Complete Response (sCR) Rate Up to 24 months sCR rate is defined as the percentage of patients who achieve a stringent complete response (sCR) according to IMWG response criteria.
Progression-free Survival (PFS) Up to 24 months 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.
Change from Baseline in Health-related Quality of Life (HRQoL) using EQ-5D-5L Questionnaire Score Baseline up to 24 months 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).
Very Good Partial Response (VGPR) Rate Up to 24 months VGPR rate is defined as the percentage of patients who achieve a VGPR or better according to IMWG response criteria.
Overall Survival (OS) Up to 24 months 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.
Change from Baseline in Health-related Quality of Life (HRQoL) using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Scale Score Baseline up to 24 months 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.
Change from Baseline in Health-related Quality of Life (HRQoL) using European Organization for Research and Treatment of Cancer (EORTC) QLQ-MY20 Scale Score Baseline up to 24 months 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).
Number of Patients with Adverse Events (AEs) Up to 24 months 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.
Trial Locations
- Locations (75)
Hosp. Puerta Del Mar
🇪🇸Cadiz, Spain
The Ohio State University
🇺🇸Columbus, Ohio, United States
Universita degli Studi di Padova - Azienda Ospedaliera di Pa
🇮🇹Padova, Italy
Università di Roma La Sapienza
🇮🇹Roma, Italy
Oncology Hematology Assoc of Central Illinois, P.C. d.b.a. Illinois CancerCare, P.C.
🇺🇸Peoria, Illinois, United States
Marin Cancer Center
🇺🇸Greenbrae, California, United States
Asclepes Research
🇺🇸Weeki Wachee, Florida, United States
Oncology Institute of Hope and Innovation
🇺🇸Glendale, California, United States
Providence Cancer Center
🇺🇸Southfield, Michigan, United States
Central Care Cancer Center
🇺🇸Bolivar, Missouri, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Hunterdon Hematology Oncology
🇺🇸Flemington, New Jersey, 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
Optum Care
🇺🇸Las Vegas, Nevada, United States
Grand Hopital de Charleroi, site Notre Dame
🇧🇪Charleroi, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Ucl de Mont-Godinne
🇧🇪Yvoir, Belgium
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
Centre hospitalier Lyon-Sud
🇫🇷Pierre-Bénite, France
C.H.U. Hotel Dieu - France
🇫🇷Nantes, France
Hopital Saint-Louis
🇫🇷Paris cedex 10, France
Hopital Saint-Antoine
🇫🇷PARIS cedex 12, France
Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik
🇩🇪Hamburg, Germany
CHU Poitiers - Hôpital la Milétrie
🇫🇷Poitiers, France
Pôle IUC Oncopole CHU
🇫🇷Toulouse cedex 9, France
Universitaetsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Universitaetsklinikum Koelnt
🇩🇪Koeln, Germany
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
Medizinische Klinik A
🇩🇪Muenster, Germany
U.O. Ematologia con Trapianto- AOU Policlinico di Bari
🇮🇹Bari, Italy
Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany
🇩🇪Tübingen, Germany
Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi
🇮🇹Bologna, Italy
U.O. Ematologia Istituto Tumori Giovanni Paolo II
🇮🇹Bari, Italy
Azienda Ospedaliera Universitaria Careggi
🇮🇹Firenze, Italy
Policlinico di Catania
🇮🇹Catania, Italy
Ospedale Villa Sofia-Cervello
🇮🇹Palermo, Italy
IRCCS Azienda Ospedaliera San Martino - IST
🇮🇹Genova, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
🇮🇹Meldola, Italy
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
Irccs Crob
🇮🇹Rionero in Vulture, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
🇮🇹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, Italy
VU Medisch Centrum
🇳🇱Amsterdam, Netherlands
UMCG
🇳🇱Groningen, Netherlands
Erasmus MC - Satellite
🇳🇱Rotterdam, Netherlands
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
🇵🇱Lublin, Poland
Szpital Kliniczny im. H. Swiecickiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Poznaniu
🇵🇱Poznan, Poland
Samara Region Clinical Hospital
🇷🇺Samara, Russian Federation
S.P. Botkin Moscow City Clinical Hospital
🇷🇺Moscow, Russian Federation
Clinical Research Institute of Hematology and Transfusiology
🇷🇺St-Petersburg, Russian Federation
Hosp. de Jerez de La Frontera
🇪🇸Jerez de la Frontera, Spain
Inst. Cat. Doncologia-H Duran I Reynals
🇪🇸Barcelona, Spain
Hosp. Univ. 12 de Octubre
🇪🇸Madrid, Spain
Hosp. de Leon
🇪🇸Leon, 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, Spain
Southmead Hospital
🇬🇧Bristol, United Kingdom
Birmingham Heartlands Hospital
🇬🇧Birmingham, 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 Kingdom
Hosp. Univ. Ramon Y Cajal
🇪🇸Madrid, Spain