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Multiple Myeloma at First RelapsePhase 2I2D IFM2021_03NCT04998786

A Multi-center Open-label Phase 2 Study of Ixazomib, Iberdomide and Dexamethasone in Elderly Patients With Multiple Myeloma at First Relapse."

A Phase 2 study testing Ixazomib, Iberdomide and Dexamethasone Oral in people with Multiple Myeloma at First Relapse, run by Nantes University Hospital at 21 sites in France.

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 phase II, multicenter, open-label study to evaluate the rate of patients achieving very good partial response (VGPR) or better to the oral combination Iberdomide Ixazomib Dexamethasone in elderly patients with multiple myeloma at first relapse . Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Multiple Myeloma at First Relapse
What is being tested?
Ixazomib, Iberdomide and Dexamethasone Oral
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
21 sitesFrance
Study dates
14 Dec 2021to 1 Jan 2030
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age > 70 years
  • Eastern Collaborative Oncology Group (ECOG) performance score of ≤2
  • Life expectancy > 6 months
  • 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.
  • Symptomatic multiple myeloma (MM) at first relapse, as defined below:
  • Symptomatic multiple myeloma according to international criteria.(Rajkumar et al, 2014)
Show all 48Show fewer
  • Relapsed MM is defined as previously treated MM that progresses and requires initiation of salvage therapy.
  • Subject must have received one prior line of therapy for at least 3 cycles.
  • 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.
  • 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)
  • Patient should comply with Celgene's pregnancy prevention plan for Iberdomide (please see appendix 8 Iberdomide Pregnancy Prevention Plan for subjects in clinical trials)
  • 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)
  • 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:
  • Subject is refractory to bortezomib, defined as progression on or within 60 days of the last dose of bortezomib.
  • Subject has had prior treatment with ixazomib, carfilzomib, pomalidomide or iberdomide
  • Subject has any of the following conditions:
  • Non-secretory or oligo-secretory MM
  • Light chain Amyloidosis (AL Amyloidosis)
  • POEMS syndrome Waldenström macroglobulinemia
  • Known Human Immunodeficiency Viral (HIV) infection
  • Active hepatitis B or C infection based on blood screen tests
  • 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
  • Major surgery within 4 weeks prior screening
  • Acute infections requiring parenteral therapy (antibiotic, antifungal or antiviral) within 14 days
  • ≥ Grade 3 Peripheral neuropathy or grade 2 with pain
  • Uncontrolled diabetes or uncontrolled hypertension within 14 days
  • Any other medical condition that, in the opinion of the Investigator, would adversely affect the subject's participation in the study
  • 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.
  • Known intolerance to steroid therapy
  • Serious medical or psychiatric illness likely to interfere with participation in study
  • Incidence of gastrointestinal disease that may significantly alter the absorption of oral drugs
  • Subjects unable or unwilling to undergo antithrombotic prophylactic treatment
  • Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision

Who cannot join

None listed.

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

France21 sites

  • CHR

    Annecy

  • CH de la cote basque

    Bayonne

  • CHRU Hopital Haut Lévêque

    Bordeaux

  • CHU

    Caen

  • CHU

    Clermont-Ferrand

  • CHRU

    Dijon

  • CHD les Oudairies

    La Roche-sur-Yon

  • CHRU Lille

    Lille

  • CHU

    Limoges

  • CH Lyon Sud

    Lyon

  • CHRU

    Nancy

  • CHU

    Nantes

  • Hopital de l'archet

    Nice

  • CHU Henri Mondor

    Paris

  • Hopital St Antoine

    Paris

  • Hôpital Cochin

    Paris

  • University Hospital

    Poitiers

  • CHRU

    Rennes

  • Centre hospitalier

    Strasbourg

  • CHU

    Toulouse

  • CHRU Bretonneau

    Tours

Other trials in France

About this study

This is a phase II, multicenter, open-label study to evaluate the rate of patients achieving very good partial response (VGPR) or better to the oral combination Iberdomide Ixazomib Dexamethasone in elderly patients with multiple myeloma at first relapse .

The patient population will consist of adult men and women more than 70 years, who meet eligibility criteria.

Following the screening period, patients will be enrolled and treated then, they will receive therapy with Iberdomide, Ixazomib and Dexaméthasone during 6 cycles and Iberdomide and Ixazomib until progression.

Being tested
Ixazomib, Iberdomide, Dexamethasone Oral
Keywords
Multiple Myeloma, elderly patients, first relapse, previous exposed, High Risk, Ixazomib, Iberdomide, Dexametasone
Medical subject headings
Multiple Myeloma

What participants receive

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

  • IxazomibDrug

    Ixazomib 3 mg/day (days 1, 8, 15) cycle 1 to until progress

  • IberdomideDrug

    Iberdomide 1.6 mg / day (day 1 to 21) cycle 1 to until progress

  • Dexamethasone OralDrug

    Cycle 1 and 2 Dexaméthasone 20 mg/day on days 1, 8, 15, 22 Cycle 3 to 6 Dexamethasone 10 mg/day on days 1, 8, 15, 22

Study groups in NCT04998786
Study groupRoleWhat they receive
assessment of treatment Ixazomib, dexamethasone, iberdomideExperimentalIberdomide, Ixazomib and Dexaméthasone during 6 cycles and Iberdomide and Ixazomib until progression
Receives: Drug: Ixazomib; Drug: Iberdomide; Drug: Dexamethasone Oral

What is being measured

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

  1. Percentage of patients have very good partial response (VGPR) or better

    Using IMWG criteria

    Measured: approximate 18 months

Secondary outcomes (13)

  1. Number of adverse events

    Number of adverse events defined by Common Terminology Criteria for Adverse Events (v5)

    Measured: approximate 18 months

  2. Number of responses

    Partial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR) and minor response (MR) will be evaluated according to IMWG

    Measured: 3 months

  3. Number of responses

    Partial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR) and minor response (MR) will be evaluated according to IMWG

    Measured: 6 months

  4. Number of the death

    is defined as the time in months from inclusion to the date of death due to any cause. Subject alive will be censored at the last known alive date.

    Measured: approximate 18 months

  5. Number of progression

    is defined as the time in months from inclusion to the date of disease progression or death due to any cause, using IMWG criteria

    Measured: approximate 18 months

  6. Percentage of time to progression

    is defined as the time in months from inclusion to the date of disease progression or death due to any cause, using IMWG criteria

    Measured: approximative 18 months

  7. Percentage of duration of response

    is defined as the time from the first response (PR or better) to the date of disease progression or death due to any cause

    Measured: approximative 18 months

  8. Percentage of duration of therapy

    is defined as the time from treatment initiation to the last dose of therapy

    Measured: approximative 18 months

  9. Percentage of time to response

    according IMWG

    Measured: approximative 18 months

  10. Percentage of Overall Response Rate

    according IMWG

    Measured: approximative 18 months

  11. Percentage of value of biological prognostic factors

    prognostic factors as ISS stage, cytogenetic as del(17p), t(4;14),

    Measured: day 1

  12. Percentage of frailty scores

    age, ECOG, comorbidity index

    Measured: day 1

  13. Percentage of score of quality of life

    To assess Quality of Life EQ5D and SF36

    Measured: approximative 18 months

Timeline

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

  1. First posted10 Aug 2021
  2. Study start14 Dec 2021
  3. Primary completion1 Jan 2030 (estimated)
  4. Study completion1 Jan 2030 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04998786
Sponsor's protocol ID
RC21_0169
Other IDs
2021-001587-13
Acronym
I2D IFM2021_03
Status last verified
Jun 2026
First submitted
4 Aug 2021
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ixazomib, Iberdomide and Dexamethasone Oral in people with Multiple Myeloma at First Relapse, run by Nantes University Hospital at 21 sites in France.

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 48 inclusion and 0 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 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in France. 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?

Percentage of patients have very good partial response (VGPR) or better (time frame: approximate 18 months). 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 NCT04998786.

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 15 Jun 2026.

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