Treatment for Elderly Fit Newly Diagnosed Multiple Myeloma Patients Aged Between 65 and 80 Years
NCT ID: NCT03742297
Last Updated: 2022-09-14
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE3
Total Enrollment
462 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-10-22
Study Completion Date
2031-01-31
Brief Summary
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The study is designed as a randomized, controlled, open-label, assessor blind, multicenter superiority trial with three parallel groups, and primary endpoint of immunophenotypic complete responses at 18 months after randomization. Block randomization will be performed with a 1:1:1 allocation ratio.
Patients will be randomized up front to 3 arms. Patients will receive "standard" PETHEMA arm for fit elderly VMP x 9 + Rd x 9 (arm 1, control arm), a KRd regimen (arm 2a) (18 cycles) or a Carfilzomib-lenalidomida-dexametasona regimen combined with DARATUMUMAB (arm 2b) (18 cycles).
Patients will be randomized up front to 3 arms. Patients will receive "standard" PETHEMA arm for fit elderly VMP x 9 + Rd x 9 (arm 1, control arm), a KRd regimen (arm 2a) (18 cycles) or a Carfilzomib-lenalidomida-dexametasona regimen combined with DARATUMUMAB (arm 2b) (18 cycles).
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Detailed Description
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After 18 cycles, patients not having received daratumumab before (arm 1 and 2a), will receive consolidation with 4 cycles of Lenalidomida-dexamethasone at low dose-DARATUMUMAB.
At this point (after 22 months on treatment for the VMP-Rd and KRd arm and after 18 months of the Carfilzomib-lenalidomida-dexametasona-DARATUMUMAB arm) patients will be stratified according MRD status by flow and in both MRD- and MRD+ groups, patients will be randomized with a 1:1 allocation ratio to:
1. no further treatment or
2. continuous treatment with DARATUMUMAB-R (daratumumab plus lenalidomide up to 2 years and then lenalidomide continuous until progression).
Patients on no maintenance that show biological relapse will be rechallenged with DARATUMUMAB-R.
The translational part will be very robust with dysplasia monitoring (especially relevant for the Bortezomib-melfalán-prednisona + Lenalidomida-dexamethasone at low dose arm), clonal evolution/resistance follow up and immune reconstitution longitudinal follow up alongside with MRD status (at diagnosis, 9 months, 18 months, 22 months and treatment discontinuation).
The trial is designed as a two-stage study (induction, followed by consolidation and maintenance). The first stage is confirmatory and addresses the primary efficacy objective. The second stage is exploratory and addresses the secondary efficacy and safety objectives.
In the first stage, investigators will compare an optimized standard induction Bortezomib, talidomida and prednisone followed by Rd (18 cycles) versus KRd, that will be tested in this trial with or without daratumumab x 18 cycles. The main objective in this stage will be to compare the immunophenotypic complete response rate assessed by next generation flow at the end of induction.
The second stage is exploratory and includes the consolidation and maintenance phases. In this second stage, the main objectives are:
1. To compare the above mentioned induction strategies in terms of PFS at the end of the different treatment phases (induction, consolidation and maintenance).
2. To investigate the capacity of consolidation with daratumumab-lenalidomide to reduce MRD levels in patients treated in the control arm as well as those that received KRd without daratumumab. In addition we will explore if this short consolidation can abrogate the potential benefit of a prolonged induction with KRd+daratumumab
3. To explore the value of maintenance therapy according to MRD status (positive or negative) to prolong PFS (after a second randomization to receive or not maintenance therapy with lenalidomide and daratumumab) In order to prevent a potential treatment deficiency for patients randomized to "no-maintenance" in both MRD+ and MRD- subgroups, they will be offered to be re-challenged with lenalidomide-daratumumab as soon as they have a biological progression and have been censored for PFS. Moreover, if 30% of the patients randomized to "no-maintenance" relapse or progress during the first year, the protocol will be amended so that all patients receive maintenance therapy.
Investigators consider that the here proposed multidrug sequential "intensive" approach designed to obtain the best possible and most durable response, assessed through the kinetics of MRD clearance, may have an impact in establishing future clinical practice in fit elderly patients. Moreover, in addition to the MRD analysis (based on next generation flow (NGF), NGS and CT-PET) comprehensive biological investigations, including immunoprofile, clonal selection, analysis of dysplastic features and circulating tumor cells, are planned in order to better understand the relationship between patients outcome and myeloma biology.
The overall treatment plan has been designed for NDMM patients not candidates to SCT strategies but fit enough to tolerate a relatively intensive therapeutic strategy. According to the International Myeloma Working Group guidelines as well as the results obtained in our GEM2010 trial for elderly patients, we have decided to restrict this trial to fit elderly patients aged between 65 and 80 years because in our experience patients older than 80 years usually intensive treatments are poorly tolerated \[1\].
Investigators will evaluate the frailty using a comprehensive health status assessment scale (Geriatric Assessment in Hematology, GAH scale, annex 11), already validated in patients with hematological diseases and preliminary results in multiple myeloma patients
At this point (after 22 months on treatment for the VMP-Rd and KRd arm and after 18 months of the Carfilzomib-lenalidomida-dexametasona-DARATUMUMAB arm) patients will be stratified according MRD status by flow and in both MRD- and MRD+ groups, patients will be randomized with a 1:1 allocation ratio to:
1. no further treatment or
2. continuous treatment with DARATUMUMAB-R (daratumumab plus lenalidomide up to 2 years and then lenalidomide continuous until progression).
Patients on no maintenance that show biological relapse will be rechallenged with DARATUMUMAB-R.
The translational part will be very robust with dysplasia monitoring (especially relevant for the Bortezomib-melfalán-prednisona + Lenalidomida-dexamethasone at low dose arm), clonal evolution/resistance follow up and immune reconstitution longitudinal follow up alongside with MRD status (at diagnosis, 9 months, 18 months, 22 months and treatment discontinuation).
The trial is designed as a two-stage study (induction, followed by consolidation and maintenance). The first stage is confirmatory and addresses the primary efficacy objective. The second stage is exploratory and addresses the secondary efficacy and safety objectives.
In the first stage, investigators will compare an optimized standard induction Bortezomib, talidomida and prednisone followed by Rd (18 cycles) versus KRd, that will be tested in this trial with or without daratumumab x 18 cycles. The main objective in this stage will be to compare the immunophenotypic complete response rate assessed by next generation flow at the end of induction.
The second stage is exploratory and includes the consolidation and maintenance phases. In this second stage, the main objectives are:
1. To compare the above mentioned induction strategies in terms of PFS at the end of the different treatment phases (induction, consolidation and maintenance).
2. To investigate the capacity of consolidation with daratumumab-lenalidomide to reduce MRD levels in patients treated in the control arm as well as those that received KRd without daratumumab. In addition we will explore if this short consolidation can abrogate the potential benefit of a prolonged induction with KRd+daratumumab
3. To explore the value of maintenance therapy according to MRD status (positive or negative) to prolong PFS (after a second randomization to receive or not maintenance therapy with lenalidomide and daratumumab) In order to prevent a potential treatment deficiency for patients randomized to "no-maintenance" in both MRD+ and MRD- subgroups, they will be offered to be re-challenged with lenalidomide-daratumumab as soon as they have a biological progression and have been censored for PFS. Moreover, if 30% of the patients randomized to "no-maintenance" relapse or progress during the first year, the protocol will be amended so that all patients receive maintenance therapy.
Investigators consider that the here proposed multidrug sequential "intensive" approach designed to obtain the best possible and most durable response, assessed through the kinetics of MRD clearance, may have an impact in establishing future clinical practice in fit elderly patients. Moreover, in addition to the MRD analysis (based on next generation flow (NGF), NGS and CT-PET) comprehensive biological investigations, including immunoprofile, clonal selection, analysis of dysplastic features and circulating tumor cells, are planned in order to better understand the relationship between patients outcome and myeloma biology.
The overall treatment plan has been designed for NDMM patients not candidates to SCT strategies but fit enough to tolerate a relatively intensive therapeutic strategy. According to the International Myeloma Working Group guidelines as well as the results obtained in our GEM2010 trial for elderly patients, we have decided to restrict this trial to fit elderly patients aged between 65 and 80 years because in our experience patients older than 80 years usually intensive treatments are poorly tolerated \[1\].
Investigators will evaluate the frailty using a comprehensive health status assessment scale (Geriatric Assessment in Hematology, GAH scale, annex 11), already validated in patients with hematological diseases and preliminary results in multiple myeloma patients
Conditions
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Newly Diagnosed Multiple Myeloma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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VMP x 9 + Lenalidomida-dexamethasone x 9
Bortezomib-melfalán-prednisone. Melfalán: 9mg/m2D1-4. Prednisone: 60mg/m2D1-4. Bortezomib: 1.3mg/m2 One 6 week cycleD1, 4, 8, 11, 22, 25, 29 and 32; followed by eight4-week cycleD1, 8, 15 and 22 Lenalidomida-dexametasona at low dose
Group Type
ACTIVE_COMPARATOR
Lenalidomide.
Intervention Type
DRUG
Lenalidomide
Bortezomib
Intervention Type
DRUG
Bortezomib
Dexamethasone
Intervention Type
DRUG
Dexamethasone
Prednisone
Intervention Type
DRUG
Prednisone
Melphalan
Intervention Type
DRUG
Melphalan
Carfilzomib-lenalidomida-dexamethasone regimen
carfilzomib: 1 st cycle: 20mg/m2 day 1 and 36 mg/m2 days 2, 8, 9 \& 15, 16. 2nd cycle: 36 mg/m2 days 1, 2, 8, 9 \& 15, 16. Cycles 3-18: 56 mg/m2 days 1, 8 \& 15.Lenalidomida: 25 mg, d1-21 Dexamethasone : 40 mg, d1, 8, 15, 2218 28-day cycle
Group Type
EXPERIMENTAL
Lenalidomide.
Intervention Type
DRUG
Lenalidomide
Carfilzomib
Intervention Type
DRUG
Carfilzomib
Dexamethasone
Intervention Type
DRUG
Dexamethasone
Carfilzomib-lenalidomida-dexamethason with daratumumab
Carfilzomib: 1 st cycle: 20mg/m2 day 1 and 36 mg/m2 days 2, 8, 9 \& 15, 16. 2nd cycle: 36 mg/m2 days 1, 2, 8, 9 \& 15, 16. Cycles 3-18: 56 mg/m2 days 1, 8 \& 15. Lenalidomida: 25 mg, d1-21 Dexamethasone: 40 mg, d1, 8, 15, 22. Daratumumab 1800mg SC Days 1, 8, 15, 22 of cycles 1-2; Days 1 and 15 of cycles 3 and 4; Day 1 of cycles 5 to 18
Group Type
EXPERIMENTAL
Lenalidomide.
Intervention Type
DRUG
Lenalidomide
Carfilzomib
Intervention Type
DRUG
Carfilzomib
Daratumumab
Intervention Type
DRUG
Daratumumab
Dexamethasone
Intervention Type
DRUG
Dexamethasone
Interventions
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Lenalidomide.
Lenalidomide
Intervention Type
DRUG
Carfilzomib
Carfilzomib
Intervention Type
DRUG
Bortezomib
Bortezomib
Intervention Type
DRUG
Daratumumab
Daratumumab
Intervention Type
DRUG
Dexamethasone
Dexamethasone
Intervention Type
DRUG
Prednisone
Prednisone
Intervention Type
DRUG
Melphalan
Melphalan
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed multiple myeloma patients who require start active treatment according to the IMWG published in 2014
* Age between 65 and 80 years, both included
* Fit patient assessed using the comprehensive health status assessment scale (Geriatric Assessment in Hematology, GAH scale, annex 11) (0-94 points GAH scale). Patients with a punctuation ≤42 will be included.
* Signed informed consent
* Patients must have measurable disease, defined as follows:
For secretory Multiple Myeloma, measurable disease is defined as the presence of quantifiable monoclonal component, ≥ 0.5 g/dL or, the urine light chains excretion is 200 mg/24h or higher.
For poor secretory or non secretory Multiple Myeloma, the level of the affected serum free light chain must be ≥ 10 mg/dL (≥ 100 mg/L, with an abnormal free light-chain ratio)
* Eastern Cooperative Oncology Group (ECOG) Performance status ≤2
* Life expectancy more than 3 months
* Adequate organ functions:
Platelet count ≥ 50000/mm3, hemoglobin ≥ 8 g/dl and absolute neutrophil count ≥ 1000/mm3. Lower values are allowed only if they are due to BM infiltration.
Aspartate Transaminase (AST) and Alanine Transaminase (ALT) ≤ 2.5 x Upper Limit of Normal.
Total bilirubin: ≤2 x Upper Limit of Normal. Serum creatinine ≤ 2 mg/dl. Calcium ≤14mg/dl or corrected serum calcium ≤14mg/dl in patients whose albumin level is out of range Left ventricle ejection fraction ≥ 40%
* At the discretion of the investigator patient must be able to adhere to all study requirements.
* Male patients that receives lenalidomide should commit to use of a condom while taking the study drug every time he has sexual contact with a pregnant female of female of childbearing potential even if he has undergone a successful vasectomy; or practice complete abstinence (when this is the preferred and usual lifestyle of the subject); including during periods of dose interruptions and for at least 30 days after treatment completion. Also males under lenalidomide should commit not to donate semen or sperm during study drug treatment, including during periods of dose interruptions, and for at least 90 days after treatment completion.
NOTE: Given the age of patients to be included on this Clinical Trial (between 65 and 80 years, both included), there is no possibility of Females of Childbearing Potential (FCBP), therefore the Pregnancy Prevention Program (annex 12) has been modified accordingly.
* Age between 65 and 80 years, both included
* Fit patient assessed using the comprehensive health status assessment scale (Geriatric Assessment in Hematology, GAH scale, annex 11) (0-94 points GAH scale). Patients with a punctuation ≤42 will be included.
* Signed informed consent
* Patients must have measurable disease, defined as follows:
For secretory Multiple Myeloma, measurable disease is defined as the presence of quantifiable monoclonal component, ≥ 0.5 g/dL or, the urine light chains excretion is 200 mg/24h or higher.
For poor secretory or non secretory Multiple Myeloma, the level of the affected serum free light chain must be ≥ 10 mg/dL (≥ 100 mg/L, with an abnormal free light-chain ratio)
* Eastern Cooperative Oncology Group (ECOG) Performance status ≤2
* Life expectancy more than 3 months
* Adequate organ functions:
Platelet count ≥ 50000/mm3, hemoglobin ≥ 8 g/dl and absolute neutrophil count ≥ 1000/mm3. Lower values are allowed only if they are due to BM infiltration.
Aspartate Transaminase (AST) and Alanine Transaminase (ALT) ≤ 2.5 x Upper Limit of Normal.
Total bilirubin: ≤2 x Upper Limit of Normal. Serum creatinine ≤ 2 mg/dl. Calcium ≤14mg/dl or corrected serum calcium ≤14mg/dl in patients whose albumin level is out of range Left ventricle ejection fraction ≥ 40%
* At the discretion of the investigator patient must be able to adhere to all study requirements.
* Male patients that receives lenalidomide should commit to use of a condom while taking the study drug every time he has sexual contact with a pregnant female of female of childbearing potential even if he has undergone a successful vasectomy; or practice complete abstinence (when this is the preferred and usual lifestyle of the subject); including during periods of dose interruptions and for at least 30 days after treatment completion. Also males under lenalidomide should commit not to donate semen or sperm during study drug treatment, including during periods of dose interruptions, and for at least 90 days after treatment completion.
NOTE: Given the age of patients to be included on this Clinical Trial (between 65 and 80 years, both included), there is no possibility of Females of Childbearing Potential (FCBP), therefore the Pregnancy Prevention Program (annex 12) has been modified accordingly.
Exclusion Criteria
* Patients older than 81 years or younger than 65
* Patients that do not qualify for fit according to the GAH scale (annex 11) (\>43 points GAH scale)
* Patients who have previously received treatment for multiple myeloma, except for steroid pulses in case of emergency, the administration of bisphosphonates or antialgesic radiotherapy or due to the presence of plasmacytomas requiring some emergency.
* Men who does not agree to use a condom every time he has sexual contact with a pregnant female or female of childbearing potential, even if he has undergone a successful vasectomy, or men who does not agree to practice complete abstinence (if this is the preferred and usual lifestyle of the subject).
* Left ventricular ejection fraction \<40% Prior history of malignancies, other than multiple myeloma (except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or the breast), unless the patient has been free of the disease for ≥ 5 years.
* Other relevant diseases or adverse clinical conditions:
Myocardial infarction within the 6 months prior to inclusion in the clinical trial A NYHA functional class III-IV, heart failure, uncontrolled angina, uncontrolled ventricular arrhythmia or acute ischemia detected electrocardiographically or conduction system anomalies.
History of significant neurological or psychiatric disorders. Active infection. Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis).
Poorly controlled arterial hypertension. Any serious medical condition or psychiatric illness that would interfere in understanding of the informed consent form.
* Human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive or active hepatitis C infection
* Limitation of the patient's ability to comply with the treatment or follow-up protocol.
* Uncontrolled endocrine diseases (i.e. diabetes mellitus, hypothyroidism or hyperthyroidism) (i.e. requiring relevant changes in medication within the last month, or hospital admission within the last 3 months).
* Patients having a peripheral neuropathy ≥ Grade 2 within the 14 days prior to inclusion.
* Known hypersensibility to any of the study drugs or their excipients.
* Patients treated with any investigational drug during the previous 30 days.
* Patients with acute diffuse infiltrative pulmonary disease and/or pericardial disease.
* Patients who are unable or unwilling to undergo antithrombotic therapy.
* Patients with severe chronic obstructive pulmonary disease (COPD) or asthma with forced expiratory volume in the first minute (FEVI) less than 50%.
* Patients that do not qualify for fit according to the GAH scale (annex 11) (\>43 points GAH scale)
* Patients who have previously received treatment for multiple myeloma, except for steroid pulses in case of emergency, the administration of bisphosphonates or antialgesic radiotherapy or due to the presence of plasmacytomas requiring some emergency.
* Men who does not agree to use a condom every time he has sexual contact with a pregnant female or female of childbearing potential, even if he has undergone a successful vasectomy, or men who does not agree to practice complete abstinence (if this is the preferred and usual lifestyle of the subject).
* Left ventricular ejection fraction \<40% Prior history of malignancies, other than multiple myeloma (except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or the breast), unless the patient has been free of the disease for ≥ 5 years.
* Other relevant diseases or adverse clinical conditions:
Myocardial infarction within the 6 months prior to inclusion in the clinical trial A NYHA functional class III-IV, heart failure, uncontrolled angina, uncontrolled ventricular arrhythmia or acute ischemia detected electrocardiographically or conduction system anomalies.
History of significant neurological or psychiatric disorders. Active infection. Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis).
Poorly controlled arterial hypertension. Any serious medical condition or psychiatric illness that would interfere in understanding of the informed consent form.
* Human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive or active hepatitis C infection
* Limitation of the patient's ability to comply with the treatment or follow-up protocol.
* Uncontrolled endocrine diseases (i.e. diabetes mellitus, hypothyroidism or hyperthyroidism) (i.e. requiring relevant changes in medication within the last month, or hospital admission within the last 3 months).
* Patients having a peripheral neuropathy ≥ Grade 2 within the 14 days prior to inclusion.
* Known hypersensibility to any of the study drugs or their excipients.
* Patients treated with any investigational drug during the previous 30 days.
* Patients with acute diffuse infiltrative pulmonary disease and/or pericardial disease.
* Patients who are unable or unwilling to undergo antithrombotic therapy.
* Patients with severe chronic obstructive pulmonary disease (COPD) or asthma with forced expiratory volume in the first minute (FEVI) less than 50%.
Minimum Eligible Age
65 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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PETHEMA Foundation
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jesús F San Miguel
Role: STUDY_CHAIR
Clínica Universidad de Navarra
Joan Blade, Dr
Role: STUDY_CHAIR
Hospital Clinic of Barcelona
Juan Jose Lahuerta, Dr
Role: STUDY_CHAIR
Hospital 12 de Octubre
Locations
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Complejo Hospitalario Universitario A Coruña
A Coruña, , Spain
Site Status
Complejo Hospitalario Universitario de Albacete
Albacete, , Spain
Site Status
Hospital General Universitario de Alicante
Alicante, , Spain
Site Status
Hospital Universitari Germans Trias i Pujol (ICO Badalona)
Badalona, , Spain
Site Status
Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Site Status
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Site Status
Hospital Universitari Vall d´Hebron
Barcelona, , Spain
Site Status
ICO L´Hospitalet
Barcelona, , Spain
Site Status
Hospital Universitario de Cruces
Bilbao, , Spain
Site Status
Complejo Hospitalario de Cáceres
Cáceres, , Spain
Site Status
Complejo Hospitalario Regional Reina Sofía
Córdoba, , Spain
Site Status
Hospital de Cabueñes
Gijón, , Spain
Site Status
Hospital Universitari Dr. Josep Trueta (ICO Girona)
Girona, , Spain
Site Status
Hospital de Especialidades de Jerez de la Frontera
Jerez de la Frontera, , Spain
Site Status
Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, , Spain
Site Status
Complejo Asistencial Universitario de León
León, , Spain
Site Status
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, , Spain
Site Status
Hospital San Pedro
Logroño, , Spain
Site Status
Complejo Hospitalario Lucus Augusti
Lugo, , Spain
Site Status
Hospital 12 de octubre
Madrid, , Spain
Site Status
Hospital clínico San Carlos
Madrid, , Spain
Site Status
Hospital Ramón y Cajal
Madrid, , Spain
Site Status
Hospital Universitario de la Princesa
Madrid, , Spain
Site Status
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Site Status
Hospital Universitario Infanta Leonor
Madrid, , Spain
Site Status
Hospital Universitario La Paz
Madrid, , Spain
Site Status
Hospital Universitario Madrid Sanchinarro
Madrid, , Spain
Site Status
HU Gregorio Marañón
Madrid, , Spain
Site Status
Hospital San Joan de Deu (Althaia)
Manresa, , Spain
Site Status
Hospital Costa del Sol
Málaga, , Spain
Site Status
Hospital Virgen de la Victoria
Málaga, , Spain
Site Status
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, , Spain
Site Status
Hospital General Universitario Morales Meseguer
Murcia, , Spain
Site Status
Hospital General Universitario Santa Lucía
Murcia, , Spain
Site Status
Hospital Universitario Central de Asturias
Oviedo, , Spain
Site Status
Hospital Son Llatzer
Palma de Mallorca, , Spain
Site Status
Hospital Universitario Son Espases
Palma de Mallorca, , Spain
Site Status
Clinica Universitaria de Navarra
Pamplona, , Spain
Site Status
Complejo Hospitalario de Navarra
Pamplona, , Spain
Site Status
Complejo Hospitalario de Pontevedra
Pontevedra, , Spain
Site Status
Hospital Universitario de Salamanca
Salamanca, , Spain
Site Status
Hospital Universitario de Donostia
San Sebastián, , Spain
Site Status
Complejo Hospitalario Universitario Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, , Spain
Site Status
Hospital Universitario de Canarias
Santa Cruz de Tenerife, , Spain
Site Status
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Site Status
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, , Spain
Site Status
Hospital General de Segovia
Segovia, , Spain
Site Status
H. Universitario Virgen de Rocío
Seville, , Spain
Site Status
Hospital Nuestra Señona de Valme
Seville, , Spain
Site Status
Hospital Universitari Joan XXIII de Tarragona
Tarragona, , Spain
Site Status
Complejo Hospitalario de Toledo (Virgen de la Salud)
Toledo, , Spain
Site Status
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Site Status
Hospital Universitari i Politecnic la Fe
Valencia, , Spain
Site Status
Hospital Universitario Dr. Peset Aleixandre
Valencia, , Spain
Site Status
Complejo Hospitalario Universitario de Vigo
Vigo, , Spain
Site Status
Hospital Txagorritxu
Vitoria-Gasteiz, , Spain
Site Status
Hospital Clínico Lozano Blesa
Zaragoza, , Spain
Site Status
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Site Status
Countries
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Spain
References
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Mateos MV, Paiva B, Cedena MT, Puig N, Sureda-Balari AM, de la Calle VG, Oriol A, Ocio EM, Rosinol L, Montes YG, Bargay J, Garcia MEG, Lakhwani S, Payer AR, Suarez-Cabrera A, Blanchard MJ, Garzon S, Montero FC, Cabanas V, de Oteyza JP, Gironella M, Martinez-Lopez J, Casasus AIT, Delgado-Beltran MP, Prieto E, Lahuerta JJ, Blade J, San-Miguel J. Induction therapy with bortezomib, melphalan, and prednisone followed by lenalidomide and dexamethasone versus carfilzomib, lenalidomide, and dexamethasone with or without daratumumab in older, fit patients with newly diagnosed multiple myeloma (GEM-2017FIT): a phase 3, open-label, multicentre, randomised clinical trial. Lancet Haematol. 2025 Aug;12(8):e588-e598. doi: 10.1016/S2352-3026(25)00143-7.
Reference Type
DERIVED
Other Identifiers
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GEM2017FIT
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
PHASE1
A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma
NCT05257083
ACTIVE_NOT_RECRUITING
PHASE3
Treatment Optimization in Patients With Untreated Multiple Myeloma
NCT02145598
TERMINATED
PHASE2/PHASE3
Bortezomib or Carfilzomib With Lenalidomide and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
NCT01863550
ACTIVE_NOT_RECRUITING
PHASE3
Bortezomib, Lenalidomide and Dexamethasone Combination Therapy in Patients With Newly Diagnosed Multiple Myeloma
NCT00378105
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma
NCT06577025
ACTIVE_NOT_RECRUITING
PHASE2
Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65
NCT01208662
ACTIVE_NOT_RECRUITING
PHASE3
Fixed Duration vs Continuous Daratumumab in Transplant Ineligible Older Adults With Newly Diagnosed Multiple Myeloma
NCT06182774
RECRUITING
PHASE3
Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment
NCT05561387
RECRUITING
PHASE3
Carfilzomib, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in High- Risk SMM
NCT03673826
ACTIVE_NOT_RECRUITING
PHASE2
A Study to Compare MPR With MP in Newly Diagnosed Multiple Myeloma Subjects 65 Years Old or Older.
NCT00405756
COMPLETED
PHASE3
Efficacy and Safety Study of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)
NCT03651128
ACTIVE_NOT_RECRUITING
PHASE3
Observational Study to Evaluate the Efficacy and Safety of Bortezomib, Melphalan, Prednisone (VMP) in Participants With Multiple Myeloma
NCT02474563
COMPLETED
Treatment With a Scheme With Low Doses of Bortezomib / Melphalan / Prednisone (MPV) in Patients With Multiple Myeloma
NCT02773550
TERMINATED
PHASE4
Belantamab Mafodotin in Newly Diagnosed Transplant Eligible Multiple Myeloma Patients
NCT04802356
ACTIVE_NOT_RECRUITING
PHASE2
A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma
NCT04181827
ACTIVE_NOT_RECRUITING
PHASE3
Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy
NCT04140162
ACTIVE_NOT_RECRUITING
PHASE2
S1211 Bortezomib, Dexamethasone, and Lenalidomide With or Without Elotuzumab in Treating Patients With Newly Diagnosed High-Risk Multiple Myeloma
NCT01668719
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma
NCT02252172
COMPLETED
PHASE3
Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years
NCT01191060
COMPLETED
PHASE3
Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed MM
NCT04009109
ACTIVE_NOT_RECRUITING
PHASE2