Newly Diagnosed Multiple MyelomaPhase 2NCT04891809
Isatuximab in Combination With Rd Compared to Rd in Elderly Patients (Aged ≥70 Years) With NDMM
A Phase 2 study testing Isatuximab-Irfc 20 MG/ML [Sarclisa], Lenalidomide and Dexamethasone Oral in people with Newly Diagnosed Multiple Myeloma, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 14 sites in 3 countries.
Trial summary
As optimal tolerance is the key for developing new treatments for the very elderly population, the aim of the study is to compare the efficacy and tolerance of isatuximab in combination with lenalidomide+dexamethasone (Rd) versus Rd only in very elderly patients aged 70 years or older. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Newly Diagnosed Multiple Myeloma
- What is being tested?
- Isatuximab-Irfc 20 MG/ML [Sarclisa], Lenalidomide and Dexamethasone Oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 20 Oct 2021to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 70 years
- Able to provide written informed consent in accordance with federal, local, and institutional guidelines
- Patients must have newly diagnosed, symptomatic multiple myeloma with evidence of measurable disease (assessed within 21 days prior to randomization)
- Serum M protein ≥0.5 g/dL measured using serum protein immunoelectrophoresis and/or
- Urine M protein ≥200 mg/24 hours measured using urine protein immunoelectrophoresis and/or
- In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) ≥100 mg/L (involved light chain) and an abnormal FLC ratio
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- No prior treatment for multiple myeloma
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2
- Patients at cardiac risk (NYHA >ll) or pre-existing coronary heart disease, or any other clinically relevant cardiac complication) should be scheduled for a baseline ECHO and can only be included if the LVEF is >40%
- Adequate organ and bone marrow function within the 21 days prior to randomization defined by:
- Bilirubin < 2 times the upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the ULN
- absolute neutrophil count (ANC) ≥ 750/mm3 (growth factor support for max 3 days allowed to achieve this value)
- Hemoglobin >8.0 g/dL (Use of erythropoietic stimulating factors and red blood cell [RBC] transfusion per institutional guidelines is allowed, however the most recent RBC transfusion may not have been done within 7 days prior to obtaining screening hemoglobin.)
- Platelet count >50,000/mm3
- Calculated or measured creatinine clearance (CrCl) of ≥30 mL/min; Calculation should be based on the MDRD formula (age, gender, black/non- black, weight, height)
Who cannot join
- ECOG status >2
- Patients unlikely to tolerate Rd
- Waldenström macroglobulinemia
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Plasma cell leukemia (> 2.0 x 10^9/L circulating plasma cells by standard differential)
- Myelodysplastic syndrome
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- Smoldering Myeloma and MGUS
- Second malignancy within the past 5 years except:
- Adequately treated basal cell or squamous cell skin cancer
- Carcinoma in situ of the cervix
- Prostate cancer ≤ Gleason score 6 with stable prostate-specific antigen (PSA over 12 months)
- Ductal breast carcinoma in situ with full surgical resection (i.e., negative margins)
- Treated medullary or papillary thyroid cancer
- Other tumors with low risk of recurrence/metastases and/or early stage R0 surgery
- History of or current amyloidosis
- Glucocorticoid therapy within the 14 days prior to randomization that exceeds an accumulated dose of 160 mg dexamethasone or 1000 mg prednisone
- Extended field radio therapy (more than 3 fields) within the 21 days prior to randomization
- Contraindication to isatuximab, dexamethasone, lenalidomide or any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs
- Active congestive heart failure (New York Heart Association [NYHA] Class III or IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, acute diffuse infiltrative pulmonary disease, pericardial disease, or myocardial infarction within 4 months prior to enrolment
- Active infection within the 14 days prior to randomization requiring systemic antibiotics and/or antiviral therapy
- Uncontrolled hypertension or uncontrolled diabetes despite medication
- Significant neuropathy (Grade 2 with pain or Grade 3 or higher) within the 14 days prior to randomization
- Known cirrhosis
- Known human immunodeficiency virus (HIV) seropositivity or active hepatitis C or hepatitis B infection (subjects with past hepatitis B virus [HBV] infection or resolved HBV infection defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti HBc] antibody test are eligible; subjects positive for hepatitis C virus [HCV] antibody are eligible only if polymerase chain reaction [PCR] is negative for HCV RNA.)
- Participation in another interventional study within the 28 days prior to randomization
- Major surgery (except kyphoplasty) within the 28 days prior to randomization
- Any other clinically significant medical disease or social condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent, be compliant with study procedures, or provide accurate information.
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
Austria9 sites
Bezirkskrankenhaus Kufstein, Innere Medizin, Interne II u. onkologische Tagesklinik
Kufstein, 6330
LKH Hochsteiermark - Leoben, Abt. f. Innere Medizin, Haemato-Onkologie
Leoben, 8700
Univ.Klinikum Krems, Klin. Abt. f. Innere Medizin 2
Mitterweng, 3500
PMU Salzburg: Universitätsklinik für Innere Medizin III
Salzburg, 5020
Univ.-Klinikum St. Pölten, Innere Medizin 1
Sankt Pölten, 3100
Krankenhaus d. Barmh. Schwestern Wien, 1. Med. Abteilung, Onkologie und Hämatologie
Vienna, 1060
Hanusch Krankenhaus der Österreichischen Gesundheitskasse, 3. Med. Abteilung
Vienna, 1140
Klinik Ottakring, 1.Med.Abt., Zentrum f. Onkologie, Haematologie und Palliativmedizin
Vienna, 1160
Krankenhaus Zams, Innere Medizin, Internistische Onkologie-Haematologie
Zams, 6511
Greece3 sites
General Hospital of Athens "Evangelismos", Hematology Clinic
Athens, 10676
General Hospital of Athens "Alexandra, Plasma Cell Dyscrasias Unit
Athens, 11528
Anticancer Hospital of Thessaloniki "Theageneio", Hematology
Thessaloniki, 54639
Serbia2 sites
University Clinical Center of Serbia, Clinic for Hematology
Belgrade, 11000
University Clinical Center Kragujevac, Clinic for Hematology
Kragujevac, 34000
About this study
Official title: Isatuximab in Combination With Lenalidomide-Dexamethasone Compared to Lenalidomide-Dexamethasone in Elderly Patients (Aged ≥70 Years) With Newly Diagnosed Myeloma: a Randomized Phase II Study (SGZ-2019-12650)
As optimal tolerance is the key for developing new treatments for the very elderly population, the aim of the study is to compare the efficacy and tolerance of isatuximab in combination with lenalidomide+dexamethasone (Rd) versus Rd only in very elderly patients aged 70 years or older. ln sum, a clear and clinically highly relevant benefit is expected with the isatuximab-based triple combination compared to the standard Rd doublet.
Read the detailed description
The treatment goals in elderly patients with multiple myeloma (MM) are similar to those in younger patients: rapid and long-lasting symptom control, deep response and durable remissions as well as increased survival are at the forefront, similar to therapy goals in younger patients. Elderly patients frequently present with comorbidities, reduced treatment tolerance and greater frequency of treatment discontinuations. Hence, treatment needs to be adapted to the specific needs of this patient population.
ln the recent decade lenalidomide-based therapies have been established as effective treatment modalities in elderly patients. In elderly patients lenalidomide + dexamethasone (Rd) is one of the most frequently used treatment regimens, which is effective and well tolerated.
MM is a high unmet medical need and as a result, several agents are currently under clinical investigation in MM. Monoclonal antibodies (mAb) are one of the most promising groups of drugs in development in the treatment of MM with several of them demonstrating activity in this disease. lsatuximab is a highly effective monoclonal antibody with an excellent activity and tolerance profile, active as single agent therapy in patients with multiple prior lines of treatment.
Presently several trials with isatuximab-lenalidomide containing treatment regimens are ongoing. The expected benefits of adding isatuximab to Rd over Rd alone in very elderly patients seem to outweigh possible risks by far.
A greater depth of response is anticipated including greater number of MRD (minimal residual disease) negative patients, higher response rates, and longer progression free survival.
Risk conferred with the addition of isatuximab are mainly restricted to a roughly 40% rate of infusion reactions, which usually are seen at the first infusion only. ln addition, there is an increased risk for grade 4 leukopenia, grade 2 and 3 thrombocytopenia, and grade 3 infection and fatigue.
- Conditions
- Newly Diagnosed Multiple Myeloma
- Being tested
- Isatuximab-Irfc 20 MG/ML [Sarclisa], Lenalidomide, Dexamethasone Oral
- Keywords
- Myeloma, Isatuximab, Lenalidomide, Dexamethasone, Elderly, age ≥70
- Medical subject headings
- Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isatuximab-Irfc 20 MG/ML [Sarclisa]Drug
Induction: 10mg/kg on day 1,8,15,22 in cycle 1, subsequently on day 1, 15; every 28 days (q28 days) Maintenance: 10mg/kg, day1, q28 days until progression or intolerance but for a maximum of 24 cycles from start of maintenance
LenalidomideDrug
Induction: 25mg*, day 1-21, every 28 days (q28 days); Maintenance: 5-10mg, day 1-21, q28 days (according to individual tolerance) until progression or intolerance but for a maximum of 24 cycles from start of maintenance
*) for patients with moderate renal impairment (30≤ GFR (MDRD formula) < 50 mL/min) starting dose is 10 mg
Dexamethasone OralDrug
Induction:
Patients aged <75 years: 40mg, once weekly; Patients aged ≥75 years: 20mg, once weekly
| Study group | Role | What they receive |
|---|---|---|
| IRd followed by IR | Experimental | Induction: 8 cycles isatuximab+lenalidomide+dexamethasone; Maintenance: up to 24 cylces isatuximab+lenalidomide Receives: Drug: Isatuximab-Irfc 20 MG/ML [Sarclisa]; Drug: Lenalidomide; Drug: Dexamethasone Oral |
| Rd followed by R | Other | Induction: 8 cycles lenalidomide+dexamethasone; Maintenance: up to 24 cylces lenalidomide Receives: Drug: Lenalidomide; Drug: Dexamethasone Oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with MRD (minimal residual disease) negativity (defined by NGF [next generation flow] at 10^-5) after end of induction treatment in the two arms.
To demonstrate the benefit of isatuximab in combination with lenalidomide and low-dose dexamethasone followed by isatuximab and lenalidomide maintenance therapy in changing the proportion of patients with MRD negativity as compared to lenalidomide and low-dose dexamethasone followed by lenalidomide maintenance treatment in patients with newly diagnosed multiple myeloma (NDMM).
Measured: After 8 months of induction treatment (8 cycles, each cyle is 28 days)
Secondary outcomes (12)
Percentage of patients with response to study treatment
Effect of treatment on Overall Response Rate (ORR) including patients with Partial Response (PR), Very Good Partial Response (VGPR) and Complete Response (CR) as per International Myeloma Working Group (IMWG) criteria in each arm.
Measured: After 32 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment)
Progression-free Survival
Effectiveness of treatments on Progression-free survival (PFS)
Measured: After 44 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment and a minimum of 12 months of follow-up)
Overall Survival
Effectiveness of treatments on Overall Survival (OS)
Measured: After 44 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment and a minimum of 12 months of follow-up)
Effectiveness of treatments on MRD negativity
To evaluate the proportion of patients with MRD negativity (defined by NGF [next generation flow] at 10^-5) after 12 months (13 cycles) of maintenance treatment.
Measured: After 20 months (8 months of induction treatment and 12 months of maintenance treatemnent)
Effectiveness of treatments on preventing progressive disease
To evaluate the Time to Progression (TTP) in each arm.
Measured: After 44 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment and a minimum of 12 months of follow-up)
Progression-free Survival in different high-risk cytogenetic populations
Effectiveness of treatment on PFS in high risk cytogenetic populations defined as patients carrying a) del(17p), t(4;14), t(14;16) in each arm and b) the same aberrations plus amp1q21.
Measured: After 44 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment and a minimum of 12 months of follow-up)
Duration of response
Length of time between response and progression or death.
Measured: After 44 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment and a minimum of 12 months of follow-up)
Incidence of treatment-emergent adverse events (Safety and tolerability)
Number of participants with treatment-emergent adverse events as assessed by NCI-CTCAE Version 5.0.
Measured: After 32 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment)
Changes in quality of life (QoL) using general questionnaire European Organization for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ) Core 30 (C 30) (EORTC-QLQ-C30)
Changes in quality of life will be analyzed by using the cancer patient-specific questionnaire EORTC-QLQ-C30.
Measured: After 32 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment)
Changes of general health status using questionnaire EQ (EuroQol) 5 dimension (5D) 5 level (5L) (EQ-5D-5L)
Changes in general health status will be analyzed by using the questionnaires EQ-5D-5L. QoL.
Measured: After 32 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment)
Changes in quality of life (QoL) using multiple myeloma specific questionnaire EORTC-QLQ Myeloma (MY) 20 (EORTC-QLQ-MY20)
Changes in quality of life will be analyzed by using the multiple myeloma-specific questionnaire EORTC-QLQ-MY20.
Measured: After 32 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment)
Progression-free survival after second line therapy
Influence of potential second line therapy on Progression-free Survival
Measured: After end of study treatment until 12 months of follow up as a minimum (until LPLV)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start20 Oct 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Newly Diagnosed Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly assigned in a 1:1 ratio to one of the two arms. Randomization will be stratified by the simplified frailty scale (Facon et al, Leukemia 2020) result nonfrail or frail.
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie
- Sponsor type
- University, hospital or other
- Collaborators
- University of Navarra, Medical University of Vienna, Assign Data Management and Biostatistics GmbH, WiSP GmbH, Sanofi
- Responsible party
- Sponsor
- Investigators
- Heinz Ludwig, Principal investigator, Wilhelminen Cancer Research Institute, Clinic Ottakring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891809
- Sponsor's protocol ID
- AGMT_MM-4
- Status last verified
- Mar 2025
- First submitted
- 12 May 2021
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Facon T, Dimopoulos MA, Meuleman N, Belch A, Mohty M, Chen WM, Kim K, Zamagni E, Rodriguez-Otero P, Renwick W, Rose C, Tempescul A, Boyle E, Manier S, Attal M, Moreau P, Macro M, Leleu X, Lorraine Chretien M, Ludwig H, Guo S, Sturniolo M, Tinel A, Silvia Monzini M, Costa B, Houck V, Hulin C, Yves Mary J. A simplified frailty scale predicts outcomes in transplant-ineligible patients with newly diagnosed multiple myeloma treated in the FIRST (MM-020) trial. Leukemia. 2020 Jan;34(1):224-233. doi: 10.1038/s41375-019-0539-0. Epub 2019 Aug 19.
PubMed 31427722
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isatuximab in Combination With Lenalidomide-Dexamethasone Compared to Lenalidomide-Dexamethasone in Elderly Patients (Aged ≥70 Years) With Newly Diagnosed Myeloma: a Randomized Phase II Study (SGZ-2019-12650)
- ClinicalTrials.gov ID
- NCT04891809
- Acronym / sponsor ID
- AGMT_MM-4
- Conditions
- Newly Diagnosed Multiple Myeloma
- Keywords
- Myeloma, Isatuximab, Lenalidomide, Dexamethasone, Elderly, age ≥70
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Arbeitsgemeinschaft medikamentoese TumortherapieUniversity, hospital or other
- Collaborators
- University of Navarra, Medical University of Vienna, Assign Data Management and Biostatistics GmbH, WiSP GmbH, Sanofi
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As optimal tolerance is the key for developing new treatments for the very elderly population, the aim of the study is to compare the efficacy and tolerance of isatuximab in combination with lenalidomide+dexamethasone (Rd) versus Rd only in very elderly patients aged 70 years or older. ln sum, a clear and clinically highly relevant benefit is expected with the isatuximab-based triple combination compared to the standard Rd doublet.
Detailed description
The treatment goals in elderly patients with multiple myeloma (MM) are similar to those in younger patients: rapid and long-lasting symptom control, deep response and durable remissions as well as increased survival are at the forefront, similar to therapy goals in younger patients. Elderly patients frequently present with comorbidities, reduced treatment tolerance and greater frequency of treatment discontinuations. Hence, treatment needs to be adapted to the specific needs of this patient population.
ln the recent decade lenalidomide-based therapies have been established as effective treatment modalities in elderly patients. In elderly patients lenalidomide + dexamethasone (Rd) is one of the most frequently used treatment regimens, which is effective and well tolerated.
MM is a high unmet medical need and as a result, several agents are currently under clinical investigation in MM. Monoclonal antibodies (mAb) are one of the most promising groups of drugs in development in the treatment of MM with several of them demonstrating activity in this disease. lsatuximab is a highly effective monoclonal antibody with an excellent activity and tolerance profile, active as single agent therapy in patients with multiple prior lines of treatment.
Presently several trials with isatuximab-lenalidomide containing treatment regimens are ongoing. The expected benefits of adding isatuximab to Rd over Rd alone in very elderly patients seem to outweigh possible risks by far.
A greater depth of response is anticipated including greater number of MRD (minimal residual disease) negative patients, higher response rates, and longer progression free survival.
Risk conferred with the addition of isatuximab are mainly restricted to a roughly 40% rate of infusion reactions, which usually are seen at the first infusion only. ln addition, there is an increased risk for grade 4 leukopenia, grade 2 and 3 thrombocytopenia, and grade 3 infection and fatigue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomly assigned in a 1:1 ratio to one of the two arms. Randomization will be stratified by the simplified frailty scale (Facon et al, Leukemia 2020) result nonfrail or frail.
| Arm | Type | Receives |
|---|---|---|
| IRd followed by IR | Experimental | Drug: Isatuximab-Irfc 20 MG/ML [Sarclisa], Drug: Lenalidomide, Drug: Dexamethasone OralInduction: 8 cycles isatuximab+lenalidomide+dexamethasone; Maintenance: up to 24 cylces isatuximab+lenalidomide |
| Rd followed by R | Other | Drug: Lenalidomide, Drug: Dexamethasone OralInduction: 8 cycles lenalidomide+dexamethasone; Maintenance: up to 24 cylces lenalidomide |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (15 listed)
- Age ≥ 70 years
- Able to provide written informed consent in accordance with federal, local, and institutional guidelines
- Patients must have newly diagnosed, symptomatic multiple myeloma with evidence of measurable disease (assessed within 21 days prior to randomization)
- No prior treatment for multiple myeloma
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2
Key exclusion criteria (27 listed)
- ECOG status >2
- Patients unlikely to tolerate Rd
- Waldenström macroglobulinemia
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Plasma cell leukemia (> 2.0 x 10^9/L circulating plasma cells by standard differential)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isatuximab-Irfc 20 MG/ML [Sarclisa]Induction: 10mg/kg on day 1,8,15,22 in cycle 1, subsequently on day 1, 15; every 28 days (q28 days) Maintenance: 10mg/kg, day1, q28 days until progression or intolerance but for a maximum of 24 cycles from start of maintenance | Drug | IRd followed by IR |
| LenalidomideInduction: 25mg*, day 1-21, every 28 days (q28 days); Maintenance: 5-10mg, day 1-21, q28 days (according to individual tolerance) until progression or intolerance but for a maximum of 24 cycles from start of maintenance *) for patients with moderate renal impairment (30≤ GFR (MDRD formula) < 50 mL/min) starting dose is 10 mg | Drug | IRd followed by IR, Rd followed by R |
| Dexamethasone OralInduction: Patients aged <75 years: 40mg, once weekly; Patients aged ≥75 years: 20mg, once weekly | Drug | IRd followed by IR, Rd followed by R |
Primary outcome
Proportion of patients with MRD (minimal residual disease) negativity (defined by NGF [next generation flow] at 10^-5) after end of induction treatment in the two arms.
Time frame: After 8 months of induction treatment (8 cycles, each cyle is 28 days)
To demonstrate the benefit of isatuximab in combination with lenalidomide and low-dose dexamethasone followed by isatuximab and lenalidomide maintenance therapy in changing the proportion of patients with MRD negativity as compared to lenalidomide and low-dose dexamethasone followed by lenalidomide maintenance treatment in patients with newly diagnosed multiple myeloma (NDMM).
12 secondary outcomes
Percentage of patients with response to study treatment
Time frame: After 32 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment)
Progression-free Survival
Time frame: After 44 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment and a minimum of 12 months of follow-up)
Overall Survival
Time frame: After 44 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment and a minimum of 12 months of follow-up)
Effectiveness of treatments on MRD negativity
Time frame: After 20 months (8 months of induction treatment and 12 months of maintenance treatemnent)
Effectiveness of treatments on preventing progressive disease
Time frame: After 44 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment and a minimum of 12 months of follow-up)
Progression-free Survival in different high-risk cytogenetic populations
Time frame: After 44 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment and a minimum of 12 months of follow-up)
Duration of response
Time frame: After 44 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment and a minimum of 12 months of follow-up)
Incidence of treatment-emergent adverse events (Safety and tolerability)
Time frame: After 32 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment)
Changes in quality of life (QoL) using general questionnaire European Organization for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ) Core 30 (C 30) (EORTC-QLQ-C30)
Time frame: After 32 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment)
Changes of general health status using questionnaire EQ (EuroQol) 5 dimension (5D) 5 level (5L) (EQ-5D-5L)
Time frame: After 32 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment)
Changes in quality of life (QoL) using multiple myeloma specific questionnaire EORTC-QLQ Myeloma (MY) 20 (EORTC-QLQ-MY20)
Time frame: After 32 months (8 months of induction treatment and a maximum of 24 months of maintenance treatment)
Progression-free survival after second line therapy
Time frame: After end of study treatment until 12 months of follow up as a minimum (until LPLV)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Background: PubMed 31427722Facon T, Dimopoulos MA, Meuleman N, Belch A, Mohty M, Chen WM, Kim K, Zamagni E, Rodriguez-Otero P, Renwick W, Rose C, Tempescul A, Boyle E, Manier S, Attal M, Moreau P, Macro M, Leleu X, Lorraine Chretien M, Ludwig H, Guo S, Sturniolo M, Tinel A, Silvia Monzini M, Costa B, Houck V, Hulin C, Yves Mary J. A simplified frailty scale predicts outcomes in transplant-ineligible patients with newly diagnosed multiple myeloma treated in the FIRST (MM-020) trial. Leukemia. 2020 Jan;34(1):224-233. doi: 10.1038/s41375-019-0539-0. Epub 2019 Aug 19.
- SponsorLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heinz Ludwig principal investigator
Wilhelminen Cancer Research Institute, Clinic Ottakring
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isatuximab-Irfc 20 MG/ML [Sarclisa], Lenalidomide and Dexamethasone Oral in people with Newly Diagnosed Multiple Myeloma, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 14 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Austria, Greece, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with MRD (minimal residual disease) negativity (defined by NGF [next generation flow] at 10^-5) after end of induction treatment in the two arms. (time frame: After 8 months of induction treatment (8 cycles, each cyle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04891809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.