New cocktail of cancer drugs aims to wipe out myeloma before transplant

NCT ID NCT05558319

Disease control Sponsor: PETHEMA Foundation Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests three different drug combinations for people with newly diagnosed multiple myeloma who are eligible for a stem cell transplant. The goal is to see which combination leads to the deepest remission (measured by minimal residual disease negativity) after 18 cycles of treatment plus transplant. About 480 participants will be randomly assigned to one of three arms: standard VRD (bortezomib, lenalidomide, dexamethasone) with early rescue, isatuximab plus VRD, or isatuximab plus iberdomide and dexamethasone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Isatuximab, Iberdomide, Bortezomib, Lenalidomide, Dexamethasone
What this could lead to: If successful, this could lead to more effective treatment combinations for multiple myeloma, helping patients achieve deeper remission and potentially longer disease control.
What could go wrong: This is an early-stage Phase 3 trial, and the new combinations may not prove better than standard therapy. Side effects from the drugs, including infections and nerve damage, are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 480 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements. 2. Patient must be able to understand the study procedures. 3. 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. 4. 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) \[Lancet Oncol. 2014;15(12): e538-e548\]. 5. 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. 6. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. 7. Patient must be ≤ 65 years of age. 8. 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% 9. 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. * She understands the need to commence study treatment as soon as it is dispensed following a negative pregnancy test. * She understands and accepts the need to undergo pregnancy testing based on the frequency outlined in this plan and in the Informed Consent. * She acknowledges she understands the hazards iberdomide or lenalidomide can cause to an unborn fetus and the necessary precautions associated with the use of study drugs. The Investigator must ensure that a WOCBP: i) Complies with the conditions of the pregnancy prevention plan, including confirmation that she has an adequate level of understanding. ii) Acknowledges the aforementioned requirements. A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 72 hours before the first dose of study drug. Nonchildbearing potential is defined as follows (by other than medical reasons): * Has not achieved menarche at some point. * Has undergone a hysterectomy or bilateral oophorectomy. * Has been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months). 10. Male patient: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male patient is eligible to participate if he agrees to the following from the time of first dose of study until 6 months after the last dose of iberdomide or lenalidomide to allow for clearance of any altered sperm: * Understand the potential teratogenic risk if engaged in sexual activity with a pregnant female or a WOCBP. * Understand the need for the use of a condom even if he has had a vasectomy, if engaged in sexual activity with a pregnant female or a FCBP * Understand the potential teratogenic risk, so the subject should not donate semen or sperm.. Understand that the effects on fertility are currently unknown, therefore all family planning options and/or alternatives should be thoroughly discussed with the study doctor prior to receiving iberdomide. 11. All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0 must be ≤ Grade 1 at the time of enrolment except for alopecia. Exclusion Criteria: 1. 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. 2. Patient has had clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS multiple myeloma. 3. 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. 4. 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. 5. Pregnant or breastfeeding females. 6. Men and women of reproductive potential who are not using effective contraceptive methods (double barrier method, intrauterine device, oral contraception). 7. Patient is simultaneously enrolled in other interventional clinical trial. 8. Patient has used an investigational drug within 28 days or five half-lives, whichever is longer, preceding the first dose of study drug. 9. 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. 10. Major surgery (except kyphoplasty) ≤ 4 weeks prior to initiating protocol therapy. 11. 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. 12. 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. 13. 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. 14. 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. 15. Evidence of active mucosal or internal bleeding. 16. Any serious medical condition or psychiatric illness that would interfere in understanding of the informed consent form. 17. 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). 18. Patient with acute diffuse infiltrative pulmonary disease and/or pericardial disease. 19. Patient with severe chronic obstructive pulmonary disease (COPD) or asthma with forced expiratory volume in the first minute (FEV1) less than 50%. 20. History of interstitial lung disease or ongoing interstitial lung disease. 21. Subject has gastrointestinal disease that may significantly alter the absorption of iberdomide and/or other oral study treatment. 22. Patient has an active infection requiring systemic antibiotic, antiviral, or antifungal treatment at the time of starting treatment. 23. Patient has known HIV infection. 24. Patient has positive hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study treatment. 25. Patient has positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment. Note: Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained. Note: Hepatitis RNA testing is optional and participants with negative Hepatitis C antibody test are not required. 26. Patient require concurrent administration of a strong inhibitor or inducer of cytochrome P450 (CYP3A4/5) (including within 14 days of initiating study treatment). 27. Patient has a known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to iberdomide or drugs chemically related to iberdomide. 28. Patient has a known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to isatuximab or drugs chemically related to isatuximab, hypersensitivity reactions, or idiosyncratic reactions to other molecular antibodies. 29. Patient has a known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to lenalidomide or dexamethasone or drugs chemically related to lenalidomide or dexamethasone.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Newly diagnosed multiple myeloma

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

65 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Clinica Universidad Navarra (CUN)
RECRUITING

Pamplona, Navarre, 31008, Spain
Complejo Asistencial Universitario de León
RECRUITING

León, Spain
Complejo Hospitalario Lucus Augusti
RECRUITING

Lugo, Spain
Complejo Hospitalario Regional Virgen Del Rocío
RECRUITING

Seville, Spain
Complejo Hospitalario Santiago (CHUS)
RECRUITING

Santiago de Compostela, Spain
Complejo Hospitalario Universitario Nuestra Señora de la Candelaria
RECRUITING

Santa Cruz de Tenerife, Spain
Complejo Hospitalario Universitario de Ourense
COMPLETED

Ourense, Spain
Complejo Hospitalario de Cáceres
RECRUITING

Cáceres, Spain
Complejo Hospitalario de Navarra
RECRUITING

Pamplona, Spain
Complejo Hospitalario de Pontevedra
RECRUITING

Pontevedra, Spain
Complejo Hospitalario de Toledo (Virgen de la Salud)
RECRUITING

Toledo, Spain
Fundación Jiménez Díaz-Ute
RECRUITING

Madrid, Spain
H. Morales Meseguer
RECRUITING

Murcia, Spain
H. U. Txagorritxu
RECRUITING

Vitoria-Gasteiz, Spain
H. Un. Virgen de la Arrixaca
RECRUITING

Murcia, Spain
H. Universitario Marqués de Valdecilla
RECRUITING

Santander, Spain
H. Universitario de Valme
RECRUITING

Seville, Spain
H.Universitario de Jerez de la Frontera
RECRUITING

Jerez de la Frontera, Spain
Hospital Arnau de Vilanova (Lleida)
RECRUITING

Lleida, Spain
Hospital Clinic i Provincial de Barcelona
RECRUITING

Barcelona, Spain
Hospital Clinico Universitario Lozano Blesa
RECRUITING

Zaragoza, Spain
Hospital Clinico Universitario Salamanca
RECRUITING

Salamanca, 37007, Spain
Hospital Clínico Universitario de Valencia
RECRUITING

Valencia, Spain
Hospital Costa del Sol
RECRUITING

Málaga, Spain
Hospital General Universitario Gregorio Marañón
RECRUITING

Madrid, Spain
Hospital General Universitario Santa Lucía
COMPLETED

Murcia, Spain
Hospital General Universitario de Albacete
RECRUITING

Albacete, Spain
Hospital General de Segovia
RECRUITING

Segovia, Spain
Hospital Germans Trias i Pujol (ICO BADALONA)
RECRUITING

Badalona, Spain
Hospital HLA Universitario Moncloa
RECRUITING

Madrid, Spain
Hospital Principe de Asturias
RECRUITING

Alcalá de Henares, Madrid, Spain
Hospital Regional de Málaga
RECRUITING

Málaga, Spain
Hospital San Pedro
RECRUITING

Logroño, Spain
Hospital Son Llatzer
RECRUITING

Palma de Mallorca, Spain
Hospital U Niversitario Virgen de La Victoria
RECRUITING

Málaga, Spain
Hospital Universitari Dr. Josep Trueta (ICO Girona)
RECRUITING

Girona, Spain
Hospital Universitari Mutua Terrassa
RECRUITING

Terrassa, Spain
Hospital Universitari Son Espases
RECRUITING

Palma de Mallorca, Spain
Hospital Universitari Vall d´Hebron
RECRUITING

Barcelona, Spain
Hospital Universitari de Tarragona Joan XXIII
RECRUITING

Tarragona, Spain
Hospital Universitari i Politecnic la Fe
RECRUITING

Valencia, Spain
Hospital Universitario 12 de octubre
RECRUITING

Madrid, Spain
Hospital Universitario Central de Asturias
RECRUITING

Oviedo, Spain
Hospital Universitario Clínico San Carlos
RECRUITING

Madrid, Spain
Hospital Universitario Dr. Peset Aleixandre
RECRUITING

Valencia, Spain
Hospital Universitario Fundación Alcorcón
COMPLETED

Madrid, Spain
Hospital Universitario HM Sanchinarro
RECRUITING

Madrid, Spain
Hospital Universitario Infanta Leonor
RECRUITING

Madrid, Spain
Hospital Universitario Infanta Sofía
RECRUITING

San Sebastián de los Reyes, Spain
Hospital Universitario La Paz
RECRUITING

Madrid, Spain
Hospital Universitario La Zarzuela
RECRUITING

Madrid, Spain
Hospital Universitario Miguel Servet
RECRUITING

Zaragoza, Spain
Hospital Universitario Puerta del Hierro
RECRUITING

Madrid, Spain
Hospital Universitario Quirón Salud Madrid
RECRUITING

Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital Universitario Ramón y Cajal
RECRUITING

Madrid, Spain
Hospital Universitario Reina Sofía
RECRUITING

Seville, Spain
Hospital Universitario Rey Juan Carlos
RECRUITING

Móstoles, Spain
Hospital Universitario Virgen de las Nieves
RECRUITING

Granada, Spain
Hospital Universitario de Burgos
RECRUITING

Burgos, 09006, Spain
Hospital Universitario de Cabueñes
RECRUITING

Gijón, Spain
Hospital Universitario de Canarias
RECRUITING

San Cristóbal de La Laguna, Spain
Hospital Universitario de Cruces
RECRUITING

Bilbao, Spain
Hospital Universitario de Donostia
RECRUITING

San Sebastián, Spain
Hospital Universitario de Fuenlabrada
RECRUITING

Madrid, Spain
Hospital Universitario de Guadalajara
RECRUITING

Guadalajara, Spain
Hospital Universitario de la Princesa
RECRUITING

Madrid, Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING

Barcelona, Spain
ICO L´Hospitalet
RECRUITING

Barcelona, Spain

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