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New pill combo shows promise for older myeloma patients

NCT ID NCT04998786

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a combination of three oral drugs—ixazomib, iberdomide, and dexamethasone—in patients over 70 with multiple myeloma that has returned after initial treatment. The goal is to see how many patients achieve a very good partial response or better. 75 participants will receive the drugs for up to 6 cycles, with two drugs continued until the disease worsens.

What this could mean

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

Active substance
ixazomib, iberdomide, and dexamethasone (oral drugs)
What this could lead to
If successful, this could offer a convenient, all-oral treatment option for elderly patients with relapsed multiple myeloma, potentially delaying disease progression.
What could go wrong
This is an early Phase 2 study with only 75 participants, so results may not apply to all patients. The drugs can cause side effects like fatigue, nausea, and low blood counts.

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

75 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Jan 2030

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

70 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: 1. Age \> 70 years 2. Eastern Collaborative Oncology Group (ECOG) performance score of ≤2 3. Life expectancy \> 6 months 4. Voluntary written informed consent must be given before performance of any study-related procedure not part of normal medical care, with the understanding that the subject may withdraw consent at any time without prejudice to future medical care. 5. Symptomatic multiple myeloma (MM) at first relapse, as defined below: * Symptomatic multiple myeloma according to international criteria.(Rajkumar et al, 2014) * Relapsed MM is defined as previously treated MM that progresses and requires initiation of salvage therapy. 6. Subject must have received one prior line of therapy for at least 3 cycles. 7. Subject has measurable disease at Screening, defined at least one of the following: * Serum M-protein ≥ 0.5 gram (g)/deciliter (dL), OR * Urine M-protein ≥ 200 mg in 24 hours, OR * Serum immunoglobulin free light chain (FLC) ≥ 10 mg/dL provided serum FLC ratio is abnormal. 8. Subjects must meet the following laboratory parameters, per laboratory reference range (performed at most 15 days before cycle 1 day 1): * Absolute neutrophil count (ANC) ≥ 1000/microliter (μL). Subjects may use growth factor support to achieve ANC eligibility criteria. * Platelet count ≥ 75,000 /mm3 for subjects in whom \< 50% of bone marrow nucleated cells are plasma cells; or a platelet count ≥ 50,000/mm3 for subjects in whom \> 50% of bone marrow nucleated cells are plasma cells. It is not permissible to transfuse subjects to achieve minimum platelet counts within 3 days before study. --AST and ALT ≤ 3 × upper limit of normal (ULN). * Total bilirubin ≤ 1.5 × ULN. Subjects with documented Gilbert's syndrome may have bilirubin \> 1.5 × ULN with the approval of the Primary Therapeutic Area Medical Director * Creatinine clearance (CrCl) ≥ 30 milliliter (mL)/minute (min) (using Cockroft and Gault Formula) 9. Patient should comply with Celgene's pregnancy prevention plan for Iberdomide (please see appendix 8 Iberdomide Pregnancy Prevention Plan for subjects in clinical trials) 10. Female patients who: * are postmenopausal for at least 24 months before the screnning visit, OR * are surgically sterile (have undergone a hysterectomy or bilateral oophorectomy) 11. Men even if surgically sterilized must agree to not father a child and agree to practice complete abstinence or to use a condom during therapy and dose interruptions and for 90 days after the last dose of study drug, even if they have had a successful vasectomy, if their partner is of childbearing potential or pregnant. Non-inclusion Criteria: 1. Subject is refractory to bortezomib, defined as progression on or within 60 days of the last dose of bortezomib. 2. Subject has had prior treatment with ixazomib, carfilzomib, pomalidomide or iberdomide 3. Subject has any of the following conditions: * Non-secretory or oligo-secretory MM * Light chain Amyloidosis (AL Amyloidosis) * POEMS syndrome Waldenström macroglobulinemia 4. Known Human Immunodeficiency Viral (HIV) infection 5. Active hepatitis B or C infection based on blood screen tests 6. Significant cardiovascular or pericardial disease, including uncontrolled angina, hypertension, arrhythmia, recent myocardial infarction within 6 months, congestive, heart failure New York Heart Association (NYHA) Class ≥ 3 7. Major surgery within 4 weeks prior screening 8. Acute infections requiring parenteral therapy (antibiotic, antifungal or antiviral) within 14 days 9. ≥ Grade 3 Peripheral neuropathy or grade 2 with pain 10. Uncontrolled diabetes or uncontrolled hypertension within 14 days 11. Any other medical condition that, in the opinion of the Investigator, would adversely affect the subject's participation in the study 12. Subject has a history of other active malignancies, including myelodysplastic syndrome (MDS), within the past 3 years prior to study entry, with the following exceptions: * Adequately treated in situ carcinoma of the cervix uteri or the breast, * Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, * Prostate cancer Gleason grade 6 or lower AND with stable Prostate Specific Antigen (PSA) levels off treatment, * Previous malignancy with no evidence of disease confined and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study. 13. Known intolerance to steroid therapy 14. Serious medical or psychiatric illness likely to interfere with participation in study 15. Incidence of gastrointestinal disease that may significantly alter the absorption of oral drugs 16. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment 17. Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision

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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

  • CH Lyon Sud

    Lyon, France

  • CH de la cote basque

    Bayonne, France

  • CHD les Oudairies

    La Roche-sur-Yon, France

  • CHR

    Annecy, France

  • CHRU

    Dijon, France

  • CHRU

    Nancy, France

  • CHRU

    Rennes, France

  • CHRU Bretonneau

    Tours, France

  • CHRU Hopital Haut Lévêque

    Bordeaux, France

  • CHRU Lille

    Lille, France

  • CHU

    Caen, France

  • CHU

    Clermont-Ferrand, France

  • CHU

    Limoges, France

  • CHU

    Nantes, France

  • CHU

    Toulouse, France

  • CHU Henri Mondor

    Paris, France

  • Centre hospitalier

    Strasbourg, France

  • Hopital St Antoine

    Paris, France

  • Hopital de l'archet

    Nice, France

  • Hôpital Cochin

    Paris, France

  • University Hospital

    Poitiers, France