A Study of Real-Life Current Standards of Care in Participants With Relapsed and/or Refractory Multiple Myeloma
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Interventions
- Other: No intervention
- Registration Number
- NCT05160584
- Lead Sponsor
- Janssen Pharmaceutica N.V., Belgium
- Brief Summary
The purpose of this study is to assess in real-life clinical practice, over a 24-month period, the effectiveness and safety and patient-reported outcomes (PROs) associated with standard of care (SOC) antimyeloma treatments in participants with previously treated relapsed and/or refractory multiple myeloma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
For Period 1, 2 and 3
- Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic criteria
- 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
- Participants must sign an informed consent form (ICF) indicating that he or she understands the purpose and observational nature of the study and is willing to participate. Consent is to be obtained prior to the initiation of any study-related data collection
- For Period 1 and 2: 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
- 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
- Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level 1.0 g/dL or urine M-protein level 200 mg/24 hours; or Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
- Period 1: Received as part of previous therapy a PI, an IMiD, and an anti-CD38 antibody (prior exposure can be from different monotherapy or combination regimens)
- Period 2: Received as part of previous therapy a PI, an IMiD, an anti-CD38 antibody, and BCMA-targeted therapy (prior exposure can be from different monotherapy or combination regimens)
- For period 3: Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level .5 g/dL or urine M-protein level 200 mg/24 hours; or Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with Relapsed/Refractory Multiple Myeloma No intervention Participants with relapsed/refractory multiple myeloma (RRMM) receiving antimyeloma treatment as standard of care (SOC) under routine clinical practice will be observed. The primary data source will be medical records of each participant.
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR) Up to 35 months 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).
- Secondary Outcome Measures
Name Time Method Very Good Partial Response (VGPR) Rate Up to 35 months VGPR rate is defined as the percentage of participants who achieve a VGPR or better response according to IMWG response criteria.
Complete Response (CR) Rate Up to 35 months CR rate is defined as the percentage of participants who achieve a CR or better response according to IMWG response criteria.
Stringent Complete Response (sCR) Rate Up to 35 months sCR rate is defined as the percentage of participants who achieve a sCR according to IMWG response criteria.
Minimal Residual Disease (MRD) Negative Rate Up to 35 months MRD negative rate is defined as the percentage of participants with negative MRD status according to IMWG response criteria.
Clinical Benefit Rate (CBR) Up to 35 months CBR is defined as the percentage of participants with clinical benefit. CBR=ORR (sCR + CR + VGPR + PR) + minimal response (MR).
Duration of Response (DOR) Up to 35 months 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.
Time to Response (TTR) Up to 35 months 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.
Time to Best Response Up to 35 months Time to best response is defined as the time between the date of Day 1 of Cycle 1 and best objective response.
Time to Next Treatment (TTNT) Up to 35 months TTNT is defined as the time from diagnosis to the start of the next-line treatment.
Progression-free Survival (PFS) Up to 35 months 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.
Time to Progression on the Next Line of Subsequent Antimyeloma Therapy or Death, Whichever Occurs First (PFS2) Up to 35 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.
Overall Survival (OS) Up to 35 months 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.
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 Baseline up to 35 months 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.
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) Baseline up to 35 months 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).
Period 1 and 2: Change from Baseline in Health-related Quality of Life (HRQoL) (Symptoms, Functioning, and Well-being) Assessed by EORTC QLQ-IL39 Baseline up to 35 months 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).
Number of Participants with Adverse Events (AEs) Up to 35 months 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.
Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Up to 35 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.
Period 3: Number of Participants Reporting Oral Toxicities Using Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Up to 35 months PRO-CTCAE consist of 1-8 questions of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference of the AEs. The following items were selected for inclusion for patients with multiple myeloma: nausea, vomiting, diarrhea, shortness of breath, rash, dizziness, headache, taste changes, and fatigue/tiredness/lack of energy.
Period 3: Number of Participants Reporting Oral Toxicity Symptoms Using the Epstein Taste Survey (ETS) Up to 35 months The Epstein Taste Survey consists of 17 items from the full 71 item PRO instrument, specific to taste changes. Developed for use in patients with head and neck cancer.
Period 3: Percentage of Participants with Overall Response to Subsequent Therapies Up to 35 months 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). Overall response for subsequent therapies, including BCMA-targeted therapies after treatment with talquetamab will be reported.
Trial Locations
- Locations (60)
LKH Leoben
🇦🇹Leoben, Austria
Heinrich-Braun-Klinikum gGmbH
🇩🇪Zwickau, Germany
University Hospital of Alexandroupolis
🇬🇷Alexandroupoli, Greece
Alexandra Hospital
🇬🇷Athens, Greece
Anticancer Hospital of Thessaloniki Theageneio
🇬🇷Thessaloniki, Greece
Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany
🇩🇪Tubingen, Germany
Hosp. Univ. Virgen de Las Nieves
🇪🇸Granada, Spain
Hosp. Clinico Univ. de Valencia
🇪🇸Valencia, Spain
Hosp. Univ. Dr. Peset
🇪🇸Valencia, Spain
Universitatsklinikum Wurzburg
🇩🇪Wuerzburg, Germany
Krankenhaus der barmherzigen Schwestern
🇦🇹Wien, Austria
UZ Leuven
🇧🇪Leuven, Belgium
Ucl de Mont-Godinne
🇧🇪Yvoir, Belgium
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, France
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
St. Barbara-Klinik Hamm GmbH
🇩🇪Hamm, Germany
Universitaetsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Staedtisches Klinikum Karlsruhe gGmbH
🇩🇪Karlsruhe, Germany
Universitaetsklinikum Leipzig
🇩🇪Leipzig, Germany
Universitaetsklinikum Koeln
🇩🇪Koeln, Germany
MVZ Mitte-Onkologische Schwerpunktpraxis
🇩🇪Leipzig, Germany
U.O. Ematologia Istituto Tumori Giovanni Paolo II
🇮🇹Bari, Italy
Hosp. de Jerez de La Frontera
🇪🇸Jerez de la Frontera, Spain
Hosp. de Leon
🇪🇸Leon, Spain
Hosp. Univ. Ramon Y Cajal
🇪🇸Madrid, Spain
Hosp. Univ. 12 de Octubre
🇪🇸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
Southmead Hospital
🇬🇧Bristol, United Kingdom
Kings College Hospital
🇬🇧London, United Kingdom
Hosp. Clinico Univ. de Valladolid
🇪🇸Valladolid, Spain
St George's Hospital
🇬🇧London, United Kingdom
Maidstone Hospital
🇬🇧Maidstone, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
The Royal Marsden NHS Trust Sutton
🇬🇧Surrey, United Kingdom
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
Università di Roma La Sapienza
🇮🇹Roma, 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
VU Medisch Centrum
🇳🇱Amsterdam, Netherlands
UMCG
🇳🇱Groningen, Netherlands
Inst. Cat. Doncologia-H Duran I Reynals
🇪🇸Barcelona, Spain
Hosp. de Cabuenes
🇪🇸Gijón, Spain
University College Hospital
🇬🇧London, United Kingdom