NDMM Patients Candidates for ASCT Comparing Extended VRD Plus vs. Isa-VRD vs. Isa-V-Iberdomide

Recruiting now · Phase 3

Conditions studied: Newly Diagnosed Multiple Myeloma

In brief

This is a Phase III open-label, 3-arm, parallel, randomized, controlled trial. The allocation ratio 1:1:1 and outcome assessment are blind to group allocation. Patients will be randomized from 3 arms. Patients will receive VRD extended + ASCT plus ERI or Isatuximab-VRD + ASCT or Isatuximab-VID + ASCT.

Key facts

Study ID

NCT05558319

Run by

PETHEMA Foundation

People needed

480

Starts

2022-11-10

Expected to finish

2029-04-01

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
• Patient must be able to understand the study procedures.
• Patient has given voluntary written informed consent before performance of any studyrelated procedure non part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
• Newly diagnosed multiple myeloma patient who requires start active treatment according to the 2014 IMWG criteria, namely clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma defining events: evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically: Hypercalcaemia, Anaemia, Renal Insufficiency, or Bone lesions (one or more osteolytic lesions on skeletal radiography, CT, or PET-CT), and any one or more of the following biomarkers: clonal BMPC% ≥60%, i/u free light ratio ≥100 or > 1 focal lesions on MRI or PET/CT) [Lancet Oncol. 2014;15(12): e538-e548].
• Patient must have a measurable secretory disease defined as either serum monoclonal protein of ≥ 0,5 g/dl or urine monoclonal (light chain) protein ≥ 200 mg/24 h. For patients whose disease is only measurable by serum FLC, the involved FLC should be ≥ 10mg/dL (100 mg/L), with an abnormal serum FLC ratio.
• Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
• Patient must be ≤ 65 years of age.
• Patient must have adequate organ function, defined as follows:
• Absolute neutrophil count (ANC) ≥1.0 X 109/L without G-CSF use in the prior 7 days
• Hemoglobin ≥8.0 g/dL (prior red blood cell (RBC) transfusion or recombinant human erythropoietin use is permitted)
• Platelets ≥ 75 x 109/L in participants in whom <50% of bone marrow nucleated cells are plasma cells and ≥ 50×109/L in participants in whom ≥50% of bone marrow nucleated cells are plasma cells (without transfusion support or thrombopoietin receptor agonist within 7 days before the laboratory test).
• Calcium Corrected serum calcium ≤13.5 mg/dL (≤3.4 mmol/L); or free ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L).
• Total bilirubin ≤2 X ULN
• ALT ≤2.5 X ULN
• AST ≤2.5 X ULN
• Renal: eGFRa: ≥40 mL/min/ 1.73 m2
• Cardiac: LVEF (echo) ≥ 50%
• Female patient: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female patient is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
• Is not a woman of childbearing potential (WOCBP), i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy OR
• Is a WOCBP and
• She understands the potential teratogenic risk to the unborn child
• She understands the need for effective contraception as stated in the protocol, without interruption, 28 days before starting study treatment, throughout the entire duration of study treatment, during dose interruptions and for at least 28 days after the last dose of study treatment.
• She understands and agrees to inform the Investigator if a change or stop of method of contraception is needed.
• She must be capable of complying with effective contraceptive measures.
• She is informed and understands the potential consequences of pregnancy and the need to notify her study doctor immediately if there is a risk of pregnancy.

You may not qualify if…

• Patient has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), plasma cell leukemia or active POEMS syndrome at the time of screening.
• Patient has had clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS multiple myeloma.
• 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.
• Any serious medical condition that places the subject at an unacceptable risk if he or she participates in this study; subjects with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and/or lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
• Pregnant or breastfeeding females.
• Men and women of reproductive potential who are not using effective contraceptive methods (double barrier method, intrauterine device, oral contraception).
• Patient is simultaneously enrolled in other interventional clinical trial.
• Patient has used an investigational drug within 28 days or five half-lives, whichever is longer, preceding the first dose of study drug.
• Patient must not have received prior radiotherapy (except localized palliative radiotherapy for pain, palliation or fracture) within 2 weeks of start of study therapy. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
• Major surgery (except kyphoplasty) ≤ 4 weeks prior to initiating protocol therapy.
• Patient has peripheral neuropathy or neuropathic pain grade 1 with pain or ≥2, as defined by the National Cancer Institute Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
• Patient evidence of cardiovascular risk including any of the following:
• Myocardial infarction within 6 months before randomization, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association Class III-IV).
• Uncontrolled cardiac arrhythmia.
• Screening 12-lead ECG showing a baseline interval QTcF> 470 msec (exception: subjects with pacemaker).
• Patients with uncontrolled hypertension.
• Patients who have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria.
• Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect patient's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfil inclusion criteria.
• Evidence of active mucosal or internal bleeding.
• Any serious medical condition or psychiatric illness that would interfere in understanding of the informed consent form.
• 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).
• Patient with acute diffuse infiltrative pulmonary disease and/or pericardial disease.
• Patient with severe chronic obstructive pulmonary disease (COPD) or asthma with forced expiratory volume in the first minute (FEV1) less than 50%.
• History of interstitial lung disease or ongoing interstitial lung disease.
• Subject has gastrointestinal disease that may significantly alter the absorption of iberdomide and/or other oral study treatment.

Where it is running

• Hospital Universitario Quirón Salud Madrid — Pozuelo de Alarcón, Madrid, Spain (enrolling)
• Clinica Universidad Navarra (CUN) — Pamplona, Navarre, Spain (enrolling)
• Hospital General Universitario de Albacete — Albacete, Spain (enrolling)
• Hospital Germans Trias i Pujol (ICO BADALONA) — Badalona, Spain (enrolling)
• Hospital Clinic i Provincial de Barcelona — Barcelona, Spain (enrolling)
• Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (enrolling)
• Hospital Universitari Vall d´Hebron — Barcelona, Spain (enrolling)
• ICO L´Hospitalet — Barcelona, Spain (enrolling)
• Hospital Universitario de Cruces — Bilbao, Spain (enrolling)
• Hospital Universitario de Burgos — Burgos, Spain (enrolling)
• Complejo Hospitalario de Cáceres — Cáceres, Spain (enrolling)
• Hospital Universitario de Cabueñes — Gijón, Spain (enrolling)
• Hospital Universitari Dr. Josep Trueta (ICO Girona) — Girona, Spain (enrolling)
• Hospital Universitario Virgen de las Nieves — Granada, Spain (enrolling)
• Hospital Universitario de Guadalajara — Guadalajara, Spain (enrolling)
• H.Universitario de Jerez de la Frontera — Jerez de la Frontera, Spain (enrolling)
• Complejo Asistencial Universitario de León — León, Spain (enrolling)
• Hospital Arnau de Vilanova (Lleida) — Lleida, Spain (enrolling)
• Hospital San Pedro — Logroño, Spain (enrolling)
• Complejo Hospitalario Lucus Augusti — Lugo, Spain (enrolling)
• Fundación Jiménez Díaz-Ute — Madrid, Spain (enrolling)
• Hospital General Universitario Gregorio Marañón — Madrid, Spain (enrolling)
• Hospital HLA Universitario Moncloa — Madrid, Spain (enrolling)
• Hospital Universitario 12 de octubre — Madrid, Spain (enrolling)
• Hospital Principe de Asturias — Alcalá de Henares, Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.