Could a new pill keep multiple myeloma in check after transplant?

NCT ID NCT04564703

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This phase 2 trial is testing the drug iberdomide (CC220) as a long-term maintenance therapy for people with newly diagnosed multiple myeloma who have already had a stem cell transplant. The goal is to see if taking iberdomide continuously can improve the depth of response and help keep the cancer from coming back. The study enrolls about 160 participants and will also monitor side effects and how well people tolerate the treatment.

What this could mean

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

Active substance
iberdomide (CC220), a drug taken continuously as maintenance therapy after autologous stem cell transplant
What this could lead to
If successful, this could lead to a new maintenance option that improves response rates and delays relapse in multiple myeloma patients after transplant.
What could go wrong
This is a phase 2 trial with a moderate number of participants, so results may not confirm long-term benefit or safety. The drug may cause side effects leading to dose reductions or discontinuation.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 160 people

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

Started

Feb 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Ages

18 years and older

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: * 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 * 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: 1. 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. 2. 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: a. 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 Exclusion Criteria: * • 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. * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • A.O. S. Maria

    Terni, Italy

  • A.O. Spedali Civili di Brescia

    Brescia, Italy

  • A.O.U. Careggi

    Florence, Italy

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

    Torino, Italy

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

    Ancona, Italy

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

    Genova, Italy

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

    Bologna, Italy

  • Albert Schweitzer Hospital

    Dordrecht, Netherlands

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

    Athens, Greece

  • Breda-Amphia Ziekenhuizen

    Breda, Netherlands

  • C.H.U. Strasbourg

    Strasbourg, France

  • CHU Hôtel-Dieu

    Nantes, France

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

    Nantes, France

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeau, France

  • Centre Hospitalier Universitaire de Dijon

    Dijon, France

  • Erasmus University Medical Center

    Rotterdam, Netherlands

  • Institut Universitaire Du Cancer De Toulose

    Toulouse, France

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

    Bolzano, Italy

  • Policlinico S. Matteo Fondazione IRCCS

    Pavia, Italy

  • Saint Antoine Hospital, Hematology Department

    Paris, France

  • Theagenio Cancer Hospital

    Thessaloniki, Greece

  • Vrije Universiteit Medical Center (VUMC)

    Amsterdam, Netherlands

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