New pill combo shows promise for older myeloma patients
NCT ID NCT04998786
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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75 people
The number who actually took part.
- Started
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Dec 2021
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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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
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70 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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CH Lyon Sud
Lyon, France
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CH de la cote basque
Bayonne, France
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CHD les Oudairies
La Roche-sur-Yon, France
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CHR
Annecy, France
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CHRU
Dijon, France
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CHRU
Nancy, France
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CHRU
Rennes, France
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CHRU Bretonneau
Tours, France
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CHRU Hopital Haut Lévêque
Bordeaux, France
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CHRU Lille
Lille, France
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CHU
Caen, France
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CHU
Clermont-Ferrand, France
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CHU
Limoges, France
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CHU
Nantes, France
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CHU
Toulouse, France
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CHU Henri Mondor
Paris, France
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Centre hospitalier
Strasbourg, France
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Hopital St Antoine
Paris, France
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Hopital de l'archet
Nice, France
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Hôpital Cochin
Paris, France
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University Hospital
Poitiers, France