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Multiple MyelomaPhase 2NCT04564703

Iberdomide (Cc220) Maintenance After Asct in Newly Diagnosed MM Patients

A Phase 2 study testing Iberdomide in people with Multiple Myeloma, run by Stichting European Myeloma Network at 22 sites in 4 countries.

Active, not recruiting

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

Official record
Search all trials

Trial summary

This is a phase II study to evaluate the efficacy and safety of different doses of iberdomide continuous therapy as maintenancetreatment after transplant. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
22 sitesin 4 countries
Study dates
22 Feb 2021to Dec 2027
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

  • Subjects with newly diagnosed MM, requiring therapy due to the presence of CRAB symptoms or myeloma defining events and measurable disease (sPEP >0.5 g/dL and/or uPEP > 200 mg/24h and/or FLC involved > 10 mg/dL with abnormal FLC ratio) before induction therapy with a PI and IMID-containing regimen-
  • Subjects with complete baseline evaluation at the time of diagnosis according to revised International Staging System (R-ISS) (cytogenetic profile, ISS and LDH)
  • Subjects treated with proteasome inhibitor plus immunomodulatory drug-based induction (3-6 cycles), followed by single or double autologous stem cell transplant (ASCT) with melphalan as condItioning regimen +/- consolidation.
  • Subjects within 12 months from diagnosis and 120 days after last ASCT, who achieved at least a partial response (PR) after ASCT, according to IMWG criteria
  • Subjects willing and able to follow the trial procedures
  • Subjects must understand and voluntary sign an ICF prior to any study related assessment/procedurs being conducted
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  • Age ≥18 years
  • ECOG performance status 0-1
  • A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) and must:
  • Have two negative pregnancy tests as verified by the Investigator prior to starting study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence* from heterosexual contact.
  • Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with two forms of contraception: one highly effective, and one additional effective (barrier) measure of contraception without interruption 28 days prior to starting investigational product, during the study treatment (including dose interruptions), and for at least 28 days after the last dose of CC-220, 90 days after the last dose of cyclophosphamide, whichever is longer. Contraception requirements are detailed in Appendix H.
  • Male subjects must:
  • Practice true abstinence* (which must be reviewed on a monthly basis and source documented) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 90 days following the last dose of study treatment, even if he has undergone a successful vasectomy.
  • True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.]
  • Males must agree to refrain from donating sperm while on study treatment, during dose interruptions and for at least 90 days following last dose of study treatment.
  • All subjects must agree to refrain from donating blood while on study treatment, during dose interruptions and for at least 28 days following the last dose of study treatment.
  • All male and female subjects must follow all requirements defined in the Pregnancy Prevention Program (v5.1). See Appendix I for CC-220 Pregnancy Prevention Plan for Subjects in Clinical Trials.
  • Subject agree to refrain from donating blood while on iberdomide, during dose interruption and for at least 28 days following the last iberdomide dose
  • Baseline values:
  • ANC ≥1.0 x 109/L without use of growth factors; PLTs≥75 x109/L (transfusions within 14 days from Day1 cycle 1 to achieve this cut off are not allowed); Hb >8 g/dL (transfusions within 14 days from Day1 cycle 1 to achieve this cut off are not allowed); • Life expectancy ≥ 3 months

Who cannot join

  • • Systemic AL amyloidosis or plasma cell leukemia (>2.0x109/L circulating plasma cells by standard differential) or Waldenstrom's macroglobulinemia
  • Subject has known meningeal involvement of multiple myeloma
  • History of active malignancy during the past 5 years, except squamous cell and basal cell carcinomas of the skin and carcinoma in situ of the cervix or breast and incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is cured, or malignancy that in the opinion of the local investigator, with concurrence with the principal investigator, is considered cured with minimal risk of recurrence within 3 years.
  • Subject with any one of the following: clinically significant abnormal electrocardiogram (ECG) findings at screening; congestive heart failure (New York Heart Association Class III or IV); myocardial infarction within 12 months prior to starting iberdomide; unstable or poorly controlled angina pectoris, including Prinzmetal variant; clinically significant pericardial disease
  • Peripheral neuropathy of ≥grade 2.
  • Subject has any concurrent severe and/or uncontrolled medical condition or psychiatric disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study or that confounds the ability to interpret data from the study.
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  • Subjects with gastrointestinal disease that may significantly alter the absorption of iberdomide
  • Subject with known history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, pomalidomide
  • Subject with known or suspected hypersensitivity to excipients contained in the formulation of iberdomide
  • Subjects has current or prior use of immunosuppressive medication within 14 days prior to starting therapy with iberdomide (exceptions are intranasal, inhaled, topical or local steroids injections; systemic corticosteroids at doses not exceeding 10 mg/day of prednisone or equivalent; steroids as premedication for hypersensitivity reactions)
  • Subject has taken a strong inhibitor or inducer of CYP3A4/5 including grapefruit, St John's wort or related products within 2 weeks prior to dosing and during the course of study
  • Subject known to test positive for HIV or have active hepatitis A, B or C
  • Subjects is unable or unwilling to undergo protocol required thromboembolism prophylaxis
  • Subject is a female who is pregnant nursing or breastfeeding or who intends to become pregnant during the participation
  • Baseline lab values:
  • Creatinine clearance ≤30 ml/min.
  • Significant hepatic dysfunction (total bilirubin > 1.5x ULN or AST/ALT > 2.5x ULN), or > 3.0 mg/dL for subjects with documented Gilbert's syndrome unless related to myeloma
  • Corrected serum calcium>13.5 mg/dL (3.4 mmol/L) • Any clinical condition at screening that would preclude subject from completing the study

Trial locations and contacts

22 sites in 4 countries.

22 sites in 4 countries

Italy9 sites

  • A.O.U. Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi di Ancona

    Ancona

  • A.O.U. di Bologna - Policlinico S. Orsola Malpighi

    Bologna

  • Ospedale Generale Regionale-Divisione di Ematologia e Centro Trapianto Midollo Osseo

    Bolzano

  • A.O. Spedali Civili di Brescia

    Brescia

  • A.O.U. Careggi

    Florence

  • A.O.U. Policlinico S. Martino - Ematologia

    Genova

  • Policlinico S. Matteo Fondazione IRCCS

    Pavia

  • A.O. S. Maria

    Terni

  • A.O.U. Città della Salute e della Scienza di Torino-Ematologia U

    Torino

Other trials in Italy

France7 sites

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeau

  • Centre Hospitalier Universitaire de Dijon

    Dijon

  • CHU Hôtel-Dieu, 1, place Alexis Ricordeau, 44093 NANTES Cedex 1, FRANCE

    Nantes

  • CHU Hôtel-Dieu

    Nantes

  • Saint Antoine Hospital, Hematology Department

    Paris

  • C.H.U. Strasbourg

    Strasbourg

  • Institut Universitaire Du Cancer De Toulose

    Toulouse

Other trials in France

Netherlands4 sites

  • Vrije Universiteit Medical Center (VUMC)

    Amsterdam

  • Breda-Amphia Ziekenhuizen

    Breda

  • Albert Schweitzer Hospital

    Dordrecht

  • Erasmus University Medical Center

    Rotterdam

Other trials in Netherlands

Greece2 sites

  • Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens

    Athens

  • Theagenio Cancer Hospital

    Thessaloniki

Other trials in Greece

About this study

Official title: Phase II Study of Iberdomide (Cc220) Maintenance After Autologous Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma Patients

This is a phase II study to evaluate the efficacy and safety of different doses of iberdomide continuous therapy as maintenancetreatment after transplant.

Read the detailed description

This is a phase II study with two parallel cohorts of newly diagnosed multiple myeloma (NDMM) patients in at least partial response (PR) after induction with proteasome inhibitors (PIs) plus IMIDs and single or double ASCT Subjects will receive two dose levels of Iberdomide, they will be evaluated for efficacy and safety. In case, in one cohort will be registered unacceptable toxicity, a third cohort will be opened. Subjects will receive treatment until progression, intolerance or unacceptable toxicity. Subsequently subjects will be followed for 24 months. The maximum number of subjects is 130 for cohort 1 and 2, 160 in case a third cohort will be opened.

Being tested
Iberdomide
Keywords
Newly diagnosed MM patients, IBERDOMIDE, Maintenance
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 (CC220) IN MAINTENANCE AFTER AUTOLOGOUS STEM CELL TRANSPLANTION IN NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS

Study groups in NCT04564703
Study groupRoleWhat they receive
cohort 1ExperimentalIberdomide will be given orally at 1.3 mg/day, from day 1 to 21 of a 28-day cycle, continuously, until progressive disease (PD) or unacceptable toxicity.
Receives: Drug: Iberdomide
cohort 2ExperimentalIberdomide will be given orally at 1.0 mg/day, from day 1 to 21 of a 28-day cycle, continuously, until progressive disease (PD) or unacceptable toxicity.
Receives: Drug: Iberdomide
cohort 3ExperimentalIberdomide will be given orally at 0.75 mg/day, from day 1 to 21 of a 28-day cycle, continuously, until progressive disease (PD) or unacceptable toxicity.
Receives: Drug: Iberdomide

What is being measured

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

  1. Efficacy: rate of improvement in response with iberdomide maintenance after autologous stem cell transplantation (ASCT)

    Response improvement rate within 6 months will be measured as the number of subjects that improve response according to IMWG criteria (from PR to ≥VGPR; from VGPR to ≥CR; from CR to >sCR) within the end of sixth cycle of treatment.

    Measured: 6 months of treatment

  2. Rate of dose reductions/discontinuations with iberdomide maintenance after ASCT

    Dose reductions/discontinuation rate within 6 months will be measured as the number of subjects that discontinued treatment or have a dose modification within the end of sixth cycle of treatment

    Measured: 6 months of treatment

Secondary outcomes (9)

  1. Rate of next-generation flow (NGF ) minimal residual disease (MRD) conversion from positive to negative.

    Rate of NGF Minimal residual disease (MRD) conversion from positive to negative.The MRD conversion rate at 6 months is determined as the proportion of subjects with MRD negativity (*10-5 sensitivity level, by NGF) after 6 months converted from status as Positive at screening.

    Measured: 6 months of treatment

  2. Rate of next-generation flow (NGF ) minimal residual disease (MRD) conversion from positive to negative.

    The MRD conversion rate at 12 months is determined as the proportion of subjects with MRD negativity (*10-5 sensitivity level, by NGF) after 12 months converted from status as Positive at screening. Subjects who withdraw from the study or are lost to follow up before post 12 months MRD evaluation, the best MRD assessment will be considered

    Measured: 12 months of treatment

  3. Rate of next-generation flow (NGF ) minimal residual disease (MRD) conversion from positive to negative.

    The best MRD conversion rate within 12 months is determined as the proportion of subjects with MRD negativity (*10-5 sensitivity level, by NGF) within 12 months converted from status as Positive at screening. Subjects who withdraw from the study or are lost to follow up before MRD evaluation, the best MRD assessment will be considered.

    Measured: 12 months of treatment

  4. Rate of adverse events

    The analysis of safety as defined by type, frequency and severity will be done primarily by tabulation of the incidence of AEs as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. In the by-subject analysis, a subject having the same event more than once will be counted only once.

    AEs will be summarized by worst CTCAE grade

    Measured: approximately 60 months

  5. Safety in different subset of subjects with different prognostic features

    Determine whether rate of adverse events may change in subgroups with different prognosis according to current prognostic factors

    Measured: approximately 60 months

  6. Efficacy in different subset of subjects with different prognostic features

    Determine whether tumor response in terms of response and survival may change in subgroups with different prognosis according to current prognostic factors

    Measured: approximately 60 months

  7. Time to Progression (TTP)

    TTP will be measured by protocol from the date of start of therapy and according to ITT from the date of eligibility confirmation to the date of first observation of PD, or deaths for PD. Subjects who have not progressed or who withdraw from the study or die from causes other than PD will be censored at the time of the last disease assessment. Subjects lost to FU will also be censored at the time of last complete disease assessment.

    Measured: approximately 60 months

  8. Progression Free Survival (PFS)

    PFS will be measured by protocol from the date of start of therapy and according to ITT from the date of eligibility confirmation to the date of first observation of PD, or death from any cause as an event. Subjects who have not progressed or who withdraw from the study or who were lost to FU will be censored at the time of the last disease assessment.

    Measured: approximately 60 months

  9. Time to next therapy (TNT)

    TNT will be measured by protocol from the date of start of therapy and according to ITT from the date of eligibility confirmation to the date of next anti-myeloma therapy. Death due to any cause before starting therapy will be considered an event. Subjects who have not progressed or who withdraw from the study

    Measured: approximately 60 months

Timeline

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

  1. First posted25 Sep 2020
  2. Study start22 Feb 2021
  3. Primary completion27 Jul 2023
  4. Study completionDec 2027 (estimated)

Resources

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
Single group
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04564703
Sponsor's protocol ID
EMN26
Status last verified
Jul 2026
First submitted
14 Sep 2020
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Iberdomide in people with Multiple Myeloma, run by Stichting European Myeloma Network at 22 sites in 4 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 20 inclusion and 18 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 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Italy, France, Netherlands, Greece. 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?

Efficacy: rate of improvement in response with iberdomide maintenance after autologous stem cell transplantation (ASCT) (time frame: 6 months of treatment). 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 NCT04564703.

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 16 Jul 2026.

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