Multiple MyelomaPhase 2NCT05527340

Iberdomide-dexamethasone Alone or in Combination With Standard MM Treatment Regimens in Transplant Ineligible Newly Diagnosed Patients.

A Phase 2 study testing Iberdomide, Dexamethasone and Daratumumab in people with Multiple Myeloma, run by PETHEMA Foundation at 9 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This is a multicenter, phase II, national, and open-label study to evaluate the efficacy and safety of two different combinations, iberdomide-dexamethasone (IBERDEX) and iberdomide-dexamethasone in combination with daratumumab (IBERDARADEX) in transplant ineligible newly diagnosed multiple myeloma (NDMM) patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma
What is being tested?: Iberdomide, Dexamethasone and Daratumumab
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 9 sitesSpain
Study dates: 15 Dec 2022to Dec 2029
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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performance of any study-related procedure nor part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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 ≥65 years or younger but non-transplant eligible who requires start active treatment according to the IMWG published in 2014.
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/L (100 mg/dl), with an abnormal serum FLC ratio.
Patient is defined as non-frail or frail using the modified-IMWG scale (APPENDIX 5). Frailty score according to the modified-IMWG scale will be collected before starting the treatment in order to ensure 30% of the patients are frail.

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Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Patient must be ≥ 18 years of age
Patient must have adequate organ function,
Female childbearing potential patient (FCBP) criteria: 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 female of childbearing potential (FNCBP) OR
Is a FCBP and
She understands the potential teratogenic risk to the unborn child
She understands the need for effective contraception, without interruption, 28 days before starting study treatment, throughout the entire duration of study treatment, during dose interruptions and for at least 3 months 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
She acknowledges she understands the hazards study drugs can cause to an unborn fetus and the necessary precautions associated with the use of study drugs.
The Investigator must ensure that a FCBP:
Complies with the conditions of the pregnancy prevention plan, including confirmation that she has an adequate level of understanding
Acknowledges the aforementioned requirements. A FCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 24 hours before the first dose of study drug(s).
Non-childbearing 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).
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 during dose interruptions and for at least 3 months following the last dose of iberdomide to allow for clearance of any altered sperm:
Understand the potential teratogenic risk if engaged in sexual activity with a pregnant female or a FCBP
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 if the subject donates 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 study drugs.
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

Who cannot join

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.
Patient has invasive malignancies other than disease under study, unless the second malignancy has been medically stable for at least 2 years and, in the opinion of the principal investigators, will not affect the evaluation of the effects of clinical trial treatments on the currently targeted malignancy. Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction.
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 lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
Pregnant or breastfeeding females.
Patient is simultaneously enrolled in other interventional clinical trial.

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Received plasmapheresis within 7 days prior to the first dose of study drug.
Patient has received prior radiotherapy 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. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
Patient has a known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to iberdomide or drugs chemically related to iberdomide, or any of the excipients contained in the formulation of the study treatment.
Patient has a known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to daratumumab or drugs chemically related to daratumumab, or any of the excipients contained in the formulation of the study treatment.
Participant has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to other monoclonal antibodies.
Patient has a known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to dexamethasone or drugs chemically related to dexamethasone, or any of the excipients contained in the formulation of the study treatment.
Major surgery (except kyphoplasty) ≤ 4 weeks prior to initiating protocol therapy.
Patient has peripheral neuropathy or neuropathic pain grade ≥2, as defined by the National Cancer Institute Terminology Criteria for Adverse Events (NCI CTC AE) Version 5.0.
Patient evidence of cardiovascular risk including any of the following:
QTcF interval QTcF > 480 msec (the QT interval values must be corrected for heart rate by Fridericia's formula [QTcF])
Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Type II) or 3rd degree atrioventricular (AV) block.
History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within six months of Screening.
Class III or IV heart failure as defined by the New York Heart Association functional classification system [NYHA, 1994]
Uncontrolled hypertension, defined as an average systolic blood pressure ≥ 160 mmHg or diastolic ≥ 100 mmHg despite optimal treatment.
Patient has 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).
Patients with acute diffuse infiltrative pulmonary disease and/or pericardial disease.
Patients 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.
Patient has an active infection requiring antibiotic, antiviral, or antifungal treatment
Participant has known HIV infection
Patient has presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study treatment.
aa.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 to also undergo Hepatitis C RNA testing.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Spain9 sites

Hospital General Universitario Gregorio Marañón
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Son Llatzer
Palma de Mallorca
Clínica Universidad de Navarra
Pamplona
Hospital Universitario de Salamanca
Salamanca
Hospital Universitario de Canarias
San Cristóbal de La Laguna
Hospital Universitario Marqués de Valdecilla
Santander
Hospital Universitario Virgen del Rocío
Seville
Hospital Universitario y Politécnico La Fe de Valencia
Valencia

Other trials in Spain

About this study

Official title: Multicenter, Phase II, National and Open-label Study to Evaluate Iberdomide-dexamethasone Alone or in Combination With Standard MM Treatment Regimens in Transplant Ineligible Newly Diagnosed Patients.

Patients will receive treatment with either iberdomide + dexamethasone (IBERDEX) or iberdomide + daratumumab + dexamethasone (IBERDARADEX), until unacceptable toxicity, disease progression, patient withdrawal, loss to follow-up, end of study or death, whichever comes first. This is not a randomized trial so eligible patients will be sequentially allocated to receive iberdomide-dexamethasone or iberdomide-dexamethasone plus daratumumab.

Read the detailed description

Participants will be evaluated for study eligibility per protocol as defined in the Inclusion/Exclusion criteria . The screening period takes place 28 days prior to the baseline visit.

Frontline treatment: cohorts 1 and 2

Cohort 1: IBERDEX

Iberdomide on days 1 to 21 at 1.6 mg, every 4 weeks, orally (PO).
Dexamethasone will be given on days 1, 8, 15, and 22 at 40 mg (patients aged ≥ 75 years: 20 mg), every 4 weeks, PO.

Cohort 2: IBERDARADEX

Iberdomide on days 1 to 21 at 1.6 mg, every 4 weeks, PO.
Dexamethasone will be given on days 1, 8, 15, and 22 at 40 mg (patients aged ≥ 75 years: 20 mg), every 4 weeks, PO.
Daratumumab will be given at 1800 mg, every 4 weeks, subcutaneously (SC). Cycles 1 and 2 (C1 and C2): Days 1, 8, 15, and 22 C3-6: Days 1 and 15 From C7 onwards: Day 1 of each cycle

The study treatment in both cohorts will be until unacceptable toxicity, disease progression, patient withdrawal, loss to follow-up, end of study or death, whichever comes first.

The trial has the following objectives:

Primary Objectives

PO1: To determine the efficacy of iberdomide in combination with dexamethasone (IBERDEX cohort 1) and also in combination with daratumumab and dexamethasone (IBERDARADEX cohort 2) in transplant ineligible NDMM patients, as measured by overall response rate (ORR) as well as the other response categories and especially the complete response rate (CRR) according to the International Myeloma Working Group (IMWG) response criteria 2016.

Secondary Objectives

SO1: To evaluate the efficacy in terms of minimal residual disease (MRD) with especial attention to the proportion of patients in MRD negative at 12 months of starting treatment as well as patients able to sustain it over time (according to the IMWG response criteria 2016).

SO2: To evaluate time to event data in the overall population and in the frail and non-frail population: Progression Free Survival (PFS) (from the time of inclusion in the trial until progression and/or death) and Overall Survival (OS).

SO3: To evaluate the changes in the immune profiling in order to better understand the outcomes in the overall population and in the non-frail and frail subgroups of patients.

SO4: To assess quality of life evolution through EQ-5D/5L, QLQ-C30 and MY20 questionnaires, at baseline and at months 4, 8, 12, 18, and 24.

SO5: To assess the safety of the combination of iberdomide + dexamethasone and iberdomide + dexamethasone + daratumumab.

Conditions: Multiple Myeloma
Being tested: Iberdomide, Dexamethasone, Daratumumab
Keywords: De novo Multiple Myeloma, Transplant ineligible
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IberdomideDrug
Iberdomide on days 1 to 21 at 1.6 mg, every 4 weeks, orally (PO)
DexamethasoneDrug
Dexamethasone 40 mg (PO) (or 20 mg (PO) if patient ≥ 75 years old) should be administered on the days 1, 8, 15 and 22 of every 4-week cycle.
DaratumumabDrug
Daratumumab will be given at 1800 mg, every 4 weeks, subcutaneously (SC). Cycles 1 and 2 (C1 and C2): Days 1, 8, 15, and 22 C3-6: Days 1 and 15 From C7 onwards: Day 1 of each cycle Cycles will be of 4 weeks of duration (28 days).

Study groups in NCT05527340
Study group	Role	What they receive
iberdomide + dexamethasone (IBERDEX)	Experimental	IBERDEX * Iberdomide on days 1 to 21 at 1.6 mg, every 4 weeks, orally (PO). * Dexamethasone will be given on days 1, 8, 15, and 22 at 40 mg (patients aged ≥ 75 years: 20 mg), every 4 weeks, PO. Receives: Drug: Iberdomide; Drug: Dexamethasone
iberdomide + daratumumab + dexamethasone (IBERDARADEX)	Experimental	IBERDARADEX * Iberdomide on days 1 to 21 at 1.6 mg, every 4 weeks, PO. * Dexamethasone will be given on days 1, 8, 15, and 22 at 40 mg (patients aged ≥ 75 years: 20 mg), every 4 weeks, PO. * Daratumumab will be given at 1800 mg, every 4 weeks, subcutaneously (SC). Cycles 1 and 2 (C1 and C2): Days 1, 8, 15, and 22 C3-6: Days 1 and 15 From C7 onwards: Day 1 of each cycle Cycles will be of 4 weeks of duration (28 days). Receives: Drug: Iberdomide; Drug: Dexamethasone; Drug: Daratumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Response Rate (ORR)
The percentage of participants with a confirmed partial response (PR) or better (PR, Very good partial response (VGPR), Complete response (CR), stringent complete response (sCR)).Response rates will be monitored monthly, but the study will report the % of patients achieving CR rate at month 12, 18, 24 and yearly thereafter.
Measured: Throught the study period. Approximately 6 years.
Complete Response Rate (CRR)
The percentage of participants with a confirmed complete response (CR) or better (stringent complete response (CR, sCR).
Measured: Throught the study period. Approximately 6 years.

Secondary outcomes (12)

Minimal Residual Disease (MRD) negativity rate
The percentage of participants who are MRD negative by next-generation flow cytometry (NGF), PET/CT, and mass spectrometry.
Measured: Throught the study period. Approximately 6 years.
Progression-Free Survival (PFS)
Time from the date of randomization until the earliest date of documented disease progression or death due to any cause.
Measured: Throught the study period. Approximately 6 years.
Overall Survival (OS)
Time from the date of randomization until the date of death due to any cause
Measured: Throught the study period. Approximately 6 years.
Changes in the immune profiling.
Relative distribution and immunophenotype of inmune profiling from baseline onto treatment, remission and disease progression.
Measured: Throught the study period. Approximately 6 years.
Health status/quality of life
Global health status/quality of life based on patient reported outcome: EQ-5D/5L questionnaire.
Measured: Baseline and throught the first 24 months.
Health status/quality of life
Global health status/quality of life based on patient reported outcome: QLQ-C30 questionnaire.
Measured: Baseline and throught the first 24 months.
Health status/quality of life
Global health status/quality of life based on patient reported outcome: MY20 questionnaire.
Measured: Baseline and throught the first 24 months.
Frequency and percentage of deaths and primary cause of death.
Incidence of deaths and primary cause of death for safety analysis.
Measured: Throught the study period. Approximately 6 years.
Incidence of adverse events (AEs).
Incidence of adverse events (AEs).
Measured: Throught the treatment period. Approximately 4 years.
Percentage of patients discontinuing therapy due to AEs.
Percentage of patients discontinuing therapy due to AEs.
Measured: Throught the treatment period. Approximately 4 years.
Percentage of patients requiring dose modifications.
Percentage of patients requiring dose modifications.
Measured: Throught the treatment period. Approximately 4 years.
Percentage of patients with changes in laboratory analytes from the hematology and blood chemistry panel.
Percentage of patients with changes in laboratory analytes from the hematology and blood chemistry panel.
Measured: Throught the treatment period. Approximately 4 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 2022Dec 2029

First posted2 Sep 2022
Study start15 Dec 2022
Primary completionDec 2029 (estimated)
Study completionDec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 140 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05527340
Sponsor's protocol ID: GEM-IBERDARAX
Other IDs: 2021-002190-25
Status last verified: May 2026
First submitted: 29 Aug 2022
Last updated: 8 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Mateos MV, San Miguel JF. Management of multiple myeloma in the newly diagnosed patient. Hematology Am Soc Hematol Educ Program. 2017 Dec 8;2017(1):498-507. doi: 10.1182/asheducation-2017.1.498.
PubMed 29222298
Durie BGM, Kumar SK, Usmani SZ, Nonyane BAS, Ammann EM, Lam A, Kobos R, Maiese EM, Facon T. Daratumumab-lenalidomide-dexamethasone vs standard-of-care regimens: Efficacy in transplant-ineligible untreated myeloma. Am J Hematol. 2020 Dec;95(12):1486-1494. doi: 10.1002/ajh.25963. Epub 2020 Sep 5.
PubMed 32804408
Belotti A, Ribolla R, Cancelli V, Crippa C, Bianchetti N, Ferrari S, Bottelli C, Cattaneo C, Tucci A, De La Fuente Barrigon C, Rossi G. Transplant eligibility in elderly multiple myeloma patients: Prospective external validation of the international myeloma working group frailty score and comparison with clinical judgment and other comorbidity scores in unselected patients aged 65-75 years. Am J Hematol. 2020 Jul;95(7):759-765. doi: 10.1002/ajh.25797. Epub 2020 Apr 23.
PubMed 32242970
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
Cruz-Jentoft AJ, Gonzalez B, de la Rubia J, Hernandez Rivas JA, Soler JA, Fernandez Lago C, Arnao M, Gironella M, Perez Persona E, Zudaire MT, Olivier C, Altes A, Garcia Guinon A, Nomdedeu B, Arnan M, Ramirez Payer A, Sanchez-Godoy P, Pajuelo N, Vilanova D, Monjil DF, Bonanad S; GAH Group. Further psychometric validation of the GAH scale: Responsiveness and effect size. J Geriatr Oncol. 2017 May;8(3):211-215. doi: 10.1016/j.jgo.2016.12.008. Epub 2016 Dec 22.
PubMed 28017687
Dimopoulos MA, Oriol A, Nahi H, San-Miguel J, Bahlis NJ, Usmani SZ, Rabin N, Orlowski RZ, Komarnicki M, Suzuki K, Plesner T, Yoon SS, Ben Yehuda D, Richardson PG, Goldschmidt H, Reece D, Lisby S, Khokhar NZ, O'Rourke L, Chiu C, Qin X, Guckert M, Ahmadi T, Moreau P; POLLUX Investigators. Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016 Oct 6;375(14):1319-1331. doi: 10.1056/NEJMoa1607751.
PubMed 27705267
Bahlis NJ, Dimopoulos MA, White DJ, Benboubker L, Cook G, Leiba M, Ho PJ, Kim K, Takezako N, Moreau P, Kaufman JL, Krevvata M, Chiu C, Qin X, Okonkwo L, Trivedi S, Ukropec J, Qi M, San-Miguel J. Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study. Leukemia. 2020 Jul;34(7):1875-1884. doi: 10.1038/s41375-020-0711-6. Epub 2020 Jan 30.
PubMed 32001798
Dimopoulos MA, San-Miguel J, Belch A, White D, Benboubker L, Cook G, Leiba M, Morton J, Ho PJ, Kim K, Takezako N, Moreau P, Kaufman JL, Sutherland HJ, Lalancette M, Magen H, Iida S, Kim JS, Prince HM, Cochrane T, Oriol A, Bahlis NJ, Chari A, O'Rourke L, Wu K, Schecter JM, Casneuf T, Chiu C, Soong D, Sasser AK, Khokhar NZ, Avet-Loiseau H, Usmani SZ. Daratumumab plus lenalidomide and dexamethasone versus lenalidomide and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of POLLUX. Haematologica. 2018 Dec;103(12):2088-2096. doi: 10.3324/haematol.2018.194282. Epub 2018 Sep 20.
PubMed 30237262
Facon T, Kumar S, Plesner T, Orlowski RZ, Moreau P, Bahlis N, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H, O'Dwyer M, Perrot A, Venner CP, Weisel K, Mace JR, Raje N, Attal M, Tiab M, Macro M, Frenzel L, Leleu X, Ahmadi T, Chiu C, Wang J, Van Rampelbergh R, Uhlar CM, Kobos R, Qi M, Usmani SZ; MAIA Trial Investigators. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Engl J Med. 2019 May 30;380(22):2104-2115. doi: 10.1056/NEJMoa1817249.
PubMed 31141632
Perrot A, Facon T, Plesner T, Usmani SZ, Kumar S, Bahlis NJ, Hulin C, Orlowski RZ, Nahi H, Mollee P, Ramasamy K, Roussel M, Jaccard A, Delforge M, Karlin L, Arnulf B, Chari A, He J, Ho KF, Van Rampelbergh R, Uhlar CM, Wang J, Kobos R, Gries KS, Fastenau J, Weisel K. Health-Related Quality of Life in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma: Findings From the Phase III MAIA Trial. J Clin Oncol. 2021 Jan 20;39(3):227-237. doi: 10.1200/JCO.20.01370. Epub 2020 Dec 16.
PubMed 33326255
Ito T, Handa H. [Cereblon as a primary target of IMiDs]. Rinsho Ketsueki. 2019;60(9):1013-1019. doi: 10.11406/rinketsu.60.1013. Japanese.
PubMed 31597822
Bjorklund CC, Kang J, Amatangelo M, Polonskaia A, Katz M, Chiu H, Couto S, Wang M, Ren Y, Ortiz M, Towfic F, Flynt JE, Pierceall W, Thakurta A. Iberdomide (CC-220) is a potent cereblon E3 ligase modulator with antitumor and immunostimulatory activities in lenalidomide- and pomalidomide-resistant multiple myeloma cells with dysregulated CRBN. Leukemia. 2020 Apr;34(4):1197-1201. doi: 10.1038/s41375-019-0620-8. Epub 2019 Nov 12. No abstract available.
PubMed 31719682
Matyskiela ME, Zhang W, Man HW, Muller G, Khambatta G, Baculi F, Hickman M, LeBrun L, Pagarigan B, Carmel G, Lu CC, Lu G, Riley M, Satoh Y, Schafer P, Daniel TO, Carmichael J, Cathers BE, Chamberlain PP. A Cereblon Modulator (CC-220) with Improved Degradation of Ikaros and Aiolos. J Med Chem. 2018 Jan 25;61(2):535-542. doi: 10.1021/acs.jmedchem.6b01921. Epub 2017 Apr 20.
PubMed 28425720
Burtis CA, Ashwood ER. Tietz Textbook of Clinical Chemistry, 3rd ed. Philadelphia; WB Saunders, 1998.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Phase II, National and Open-label Study to Evaluate Iberdomide-dexamethasone Alone or in Combination With Standard MM Treatment Regimens in Transplant Ineligible Newly Diagnosed Patients.
ClinicalTrials.gov ID: NCT05527340
Acronym / sponsor ID: GEM-IBERDARAX
Conditions: Multiple Myeloma
Keywords: De novo Multiple Myeloma, Transplant ineligible
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 140 participants (estimated)
Lead sponsor: PETHEMA FoundationUniversity, hospital or other
Collaborators: Celgene, Janssen-Cilag, S.A., LIDESEC SL
Study start: 15 Dec 2022 (actual)
Primary completion: Dec 2029 (estimated)
Study completion: Dec 2029 (estimated)
First posted: 2 Sep 2022 (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.

Detailed description

Participants will be evaluated for study eligibility per protocol as defined in the Inclusion/Exclusion criteria . The screening period takes place 28 days prior to the baseline visit.

Frontline treatment: cohorts 1 and 2

Cohort 1: IBERDEX

Iberdomide on days 1 to 21 at 1.6 mg, every 4 weeks, orally (PO).
Dexamethasone will be given on days 1, 8, 15, and 22 at 40 mg (patients aged ≥ 75 years: 20 mg), every 4 weeks, PO.

Cohort 2: IBERDARADEX

Iberdomide on days 1 to 21 at 1.6 mg, every 4 weeks, PO.
Dexamethasone will be given on days 1, 8, 15, and 22 at 40 mg (patients aged ≥ 75 years: 20 mg), every 4 weeks, PO.
Daratumumab will be given at 1800 mg, every 4 weeks, subcutaneously (SC). Cycles 1 and 2 (C1 and C2): Days 1, 8, 15, and 22 C3-6: Days 1 and 15 From C7 onwards: Day 1 of each cycle

The study treatment in both cohorts will be until unacceptable toxicity, disease progression, patient withdrawal, loss to follow-up, end of study or death, whichever comes first.

The trial has the following objectives:

Primary Objectives

Secondary Objectives

SO3: To evaluate the changes in the immune profiling in order to better understand the outcomes in the overall population and in the non-frail and frail subgroups of patients.

SO4: To assess quality of life evolution through EQ-5D/5L, QLQ-C30 and MY20 questionnaires, at baseline and at months 4, 8, 12, 18, and 24.

SO5: To assess the safety of the combination of iberdomide + dexamethasone and iberdomide + dexamethasone + daratumumab.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
iberdomide + dexamethasone (IBERDEX)	Experimental	Drug: Iberdomide, Drug: DexamethasoneIBERDEX * Iberdomide on days 1 to 21 at 1.6 mg, every 4 weeks, orally (PO). * Dexamethasone will be given on days 1, 8, 15, and 22 at 40 mg (patients aged ≥ 75 years: 20 mg), every 4 weeks, PO.
iberdomide + daratumumab + dexamethasone (IBERDARADEX)	Experimental	Drug: Iberdomide, Drug: Dexamethasone, Drug: DaratumumabIBERDARADEX * Iberdomide on days 1 to 21 at 1.6 mg, every 4 weeks, PO. * Dexamethasone will be given on days 1, 8, 15, and 22 at 40 mg (patients aged ≥ 75 years: 20 mg), every 4 weeks, PO. * Daratumumab will be given at 1800 mg, every 4 weeks, subcutaneously (SC). Cycles 1 and 2 (C1 and C2): Days 1, 8, 15, and 22 C3-6: Days 1 and 15 From C7 onwards: Day 1 of each cycle Cycles will be of 4 weeks of duration (28 days).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (35 listed)

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 study-related procedure nor 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 ≥65 years or younger but non-transplant eligible who requires start active treatment according to the IMWG published in 2014.
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/L (100 mg/dl), with an abnormal serum FLC ratio.

Key exclusion criteria (34 listed)

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.
Patient has invasive malignancies other than disease under study, unless the second malignancy has been medically stable for at least 2 years and, in the opinion of the principal investigators, will not affect the evaluation of the effects of clinical trial treatments on the currently targeted malignancy. Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction.
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 lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
Pregnant or breastfeeding females.

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
IberdomideIberdomide on days 1 to 21 at 1.6 mg, every 4 weeks, orally (PO)	Drug	iberdomide + daratumumab + dexamethasone (IBERDARADEX), iberdomide + dexamethasone (IBERDEX)
DexamethasoneDexamethasone 40 mg (PO) (or 20 mg (PO) if patient ≥ 75 years old) should be administered on the days 1, 8, 15 and 22 of every 4-week cycle.	Drug	iberdomide + daratumumab + dexamethasone (IBERDARADEX), iberdomide + dexamethasone (IBERDEX)
DaratumumabDaratumumab will be given at 1800 mg, every 4 weeks, subcutaneously (SC). Cycles 1 and 2 (C1 and C2): Days 1, 8, 15, and 22 C3-6: Days 1 and 15 From C7 onwards: Day 1 of each cycle Cycles will be of 4 weeks of duration (28 days).	Drug	iberdomide + daratumumab + dexamethasone (IBERDARADEX)

Primary outcome

Overall Response Rate (ORR)
Time frame: Throught the study period. Approximately 6 years.
The percentage of participants with a confirmed partial response (PR) or better (PR, Very good partial response (VGPR), Complete response (CR), stringent complete response (sCR)).Response rates will be monitored monthly, but the study will report the % of patients achieving CR rate at month 12, 18, 24 and yearly thereafter.
Complete Response Rate (CRR)
Time frame: Throught the study period. Approximately 6 years.
The percentage of participants with a confirmed complete response (CR) or better (stringent complete response (CR, sCR).

12 secondary outcomes

Minimal Residual Disease (MRD) negativity rate
Time frame: Throught the study period. Approximately 6 years.
Progression-Free Survival (PFS)
Time frame: Throught the study period. Approximately 6 years.
Overall Survival (OS)
Time frame: Throught the study period. Approximately 6 years.
Changes in the immune profiling.
Time frame: Throught the study period. Approximately 6 years.
Health status/quality of life
Time frame: Baseline and throught the first 24 months.
Health status/quality of life
Time frame: Baseline and throught the first 24 months.
Health status/quality of life
Time frame: Baseline and throught the first 24 months.
Frequency and percentage of deaths and primary cause of death.
Time frame: Throught the study period. Approximately 6 years.
Incidence of adverse events (AEs).
Time frame: Throught the treatment period. Approximately 4 years.
Percentage of patients discontinuing therapy due to AEs.
Time frame: Throught the treatment period. Approximately 4 years.
Percentage of patients requiring dose modifications.
Time frame: Throught the treatment period. Approximately 4 years.
Percentage of patients with changes in laboratory analytes from the hematology and blood chemistry panel.
Time frame: Throught the treatment period. Approximately 4 years.

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 8 May 2026.
Background: PubMed 29222298Mateos MV, San Miguel JF. Management of multiple myeloma in the newly diagnosed patient. Hematology Am Soc Hematol Educ Program. 2017 Dec 8;2017(1):498-507. doi: 10.1182/asheducation-2017.1.498.
Background: PubMed 32804408Durie BGM, Kumar SK, Usmani SZ, Nonyane BAS, Ammann EM, Lam A, Kobos R, Maiese EM, Facon T. Daratumumab-lenalidomide-dexamethasone vs standard-of-care regimens: Efficacy in transplant-ineligible untreated myeloma. Am J Hematol. 2020 Dec;95(12):1486-1494. doi: 10.1002/ajh.25963. Epub 2020 Sep 5.
Background: PubMed 32242970Belotti A, Ribolla R, Cancelli V, Crippa C, Bianchetti N, Ferrari S, Bottelli C, Cattaneo C, Tucci A, De La Fuente Barrigon C, Rossi G. Transplant eligibility in elderly multiple myeloma patients: Prospective external validation of the international myeloma working group frailty score and comparison with clinical judgment and other comorbidity scores in unselected patients aged 65-75 years. Am J Hematol. 2020 Jul;95(7):759-765. doi: 10.1002/ajh.25797. Epub 2020 Apr 23.
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.
Background: PubMed 28017687Cruz-Jentoft AJ, Gonzalez B, de la Rubia J, Hernandez Rivas JA, Soler JA, Fernandez Lago C, Arnao M, Gironella M, Perez Persona E, Zudaire MT, Olivier C, Altes A, Garcia Guinon A, Nomdedeu B, Arnan M, Ramirez Payer A, Sanchez-Godoy P, Pajuelo N, Vilanova D, Monjil DF, Bonanad S; GAH Group. Further psychometric validation of the GAH scale: Responsiveness and effect size. J Geriatr Oncol. 2017 May;8(3):211-215. doi: 10.1016/j.jgo.2016.12.008. Epub 2016 Dec 22.
Background: PubMed 27705267Dimopoulos MA, Oriol A, Nahi H, San-Miguel J, Bahlis NJ, Usmani SZ, Rabin N, Orlowski RZ, Komarnicki M, Suzuki K, Plesner T, Yoon SS, Ben Yehuda D, Richardson PG, Goldschmidt H, Reece D, Lisby S, Khokhar NZ, O'Rourke L, Chiu C, Qin X, Guckert M, Ahmadi T, Moreau P; POLLUX Investigators. Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016 Oct 6;375(14):1319-1331. doi: 10.1056/NEJMoa1607751.
Background: PubMed 32001798Bahlis NJ, Dimopoulos MA, White DJ, Benboubker L, Cook G, Leiba M, Ho PJ, Kim K, Takezako N, Moreau P, Kaufman JL, Krevvata M, Chiu C, Qin X, Okonkwo L, Trivedi S, Ukropec J, Qi M, San-Miguel J. Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study. Leukemia. 2020 Jul;34(7):1875-1884. doi: 10.1038/s41375-020-0711-6. Epub 2020 Jan 30.
Background: PubMed 30237262Dimopoulos MA, San-Miguel J, Belch A, White D, Benboubker L, Cook G, Leiba M, Morton J, Ho PJ, Kim K, Takezako N, Moreau P, Kaufman JL, Sutherland HJ, Lalancette M, Magen H, Iida S, Kim JS, Prince HM, Cochrane T, Oriol A, Bahlis NJ, Chari A, O'Rourke L, Wu K, Schecter JM, Casneuf T, Chiu C, Soong D, Sasser AK, Khokhar NZ, Avet-Loiseau H, Usmani SZ. Daratumumab plus lenalidomide and dexamethasone versus lenalidomide and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of POLLUX. Haematologica. 2018 Dec;103(12):2088-2096. doi: 10.3324/haematol.2018.194282. Epub 2018 Sep 20.
Background: PubMed 31141632Facon T, Kumar S, Plesner T, Orlowski RZ, Moreau P, Bahlis N, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H, O'Dwyer M, Perrot A, Venner CP, Weisel K, Mace JR, Raje N, Attal M, Tiab M, Macro M, Frenzel L, Leleu X, Ahmadi T, Chiu C, Wang J, Van Rampelbergh R, Uhlar CM, Kobos R, Qi M, Usmani SZ; MAIA Trial Investigators. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Engl J Med. 2019 May 30;380(22):2104-2115. doi: 10.1056/NEJMoa1817249.
Background: PubMed 33326255Perrot A, Facon T, Plesner T, Usmani SZ, Kumar S, Bahlis NJ, Hulin C, Orlowski RZ, Nahi H, Mollee P, Ramasamy K, Roussel M, Jaccard A, Delforge M, Karlin L, Arnulf B, Chari A, He J, Ho KF, Van Rampelbergh R, Uhlar CM, Wang J, Kobos R, Gries KS, Fastenau J, Weisel K. Health-Related Quality of Life in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma: Findings From the Phase III MAIA Trial. J Clin Oncol. 2021 Jan 20;39(3):227-237. doi: 10.1200/JCO.20.01370. Epub 2020 Dec 16.
Background: PubMed 31597822Ito T, Handa H. [Cereblon as a primary target of IMiDs]. Rinsho Ketsueki. 2019;60(9):1013-1019. doi: 10.11406/rinketsu.60.1013. Japanese.
Background: PubMed 31719682Bjorklund CC, Kang J, Amatangelo M, Polonskaia A, Katz M, Chiu H, Couto S, Wang M, Ren Y, Ortiz M, Towfic F, Flynt JE, Pierceall W, Thakurta A. Iberdomide (CC-220) is a potent cereblon E3 ligase modulator with antitumor and immunostimulatory activities in lenalidomide- and pomalidomide-resistant multiple myeloma cells with dysregulated CRBN. Leukemia. 2020 Apr;34(4):1197-1201. doi: 10.1038/s41375-019-0620-8. Epub 2019 Nov 12. No abstract available.

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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.

María Victoria Mateos Manteca study chair

University of Salamanca

Verónica González de la Calle study chair

University of Salamanca

Jesús San Miguel Izquierdo study chair

Clinica Universidad de Navarra, Universidad de Navarra

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Iberdomide, Dexamethasone and Daratumumab in people with Multiple Myeloma, run by PETHEMA Foundation at 9 sites in Spain.

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 35 inclusion and 34 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 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Spain. 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?

Overall Response Rate (ORR) (time frame: Throught the study period. Approximately 6 years.). The study lists 2 primary outcomes in all. 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 NCT05527340, which also lists 14 linked publications.

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 8 May 2026.