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Multiple MyelomaPhase 2IDARANCT03757221

Ixazomib -Daratumumab Without Dexamethasone (IDara) in Elderly Relapse Refractory Multiple Myeloma

A Phase 2 study testing Ixazomib and Daratumumab in people with Multiple Myeloma, run by University Hospital, Caen at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Multiple myeloma is an incurable hematological malignancy that affects older patients. Currently, despite recent progress, the disease relapses more or less quickly after initial treatment and requires the resumption of treatment with new drugs associated with cortisone, whose side effects are important. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Ixazomib and Daratumumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteFrance
Study dates
7 Feb 2019to 28 Apr 2024
Phase
Phase 2
Are there results?
None posted in the registry

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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Must be able to understand and voluntarily sign an informed consent form
  • Must be able to adhere to the study visit schedule and other protocol requirements
  • Age >= 65 years
  • Subjects affiliated with an appropriate social security system.
  • Life expectancy > 6 months
  • Patients must have relapsed myeloma, and have been previously treated with Bortezomib, Melphalan and Prednisone (VMP) or Lenalidomide and Dexamethasone (Rd), or both:
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  • One or two line(s) of prior therapies
  • Patients must have Progressive Disease as defined by the IMWG as one of the following (Kumar, 2016): Increase of 25% from lowest response value in any one or more of the following:
  • Serum M-component (absolute increase must be ≥ 0.5 g/100 ml) and/or Urine M-component (absolute increase must be ≥ 200 mg per 24 h) and/or
  • Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/l).
  • Bone marrow plasma cell percentage (absolute % must be ≥ 10%)
  • Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas
  • Development of hypercalcemia (corrected serum calcium > 11.5 mg/100 ml) that can be attributed solely to the plasma cell proliferative disorder
  • Patients must have undergone prior treatment with VMP or Rd:
  • They must have received at least two cycles of therapy
  • Either at diagnosis or relapse
  • Patients must have a clearly detectable and quantifiable monoclonal M-component value: IgG (serum M-component > 10g/l) ; IgA (serum M-component > 5g/l) ; IgD (serum M-component > 0.5g/l); Light chain (serum M-component >1g/l or Bence Jones > 200 mg/24H) In patients without measurable serum and urine M-protein levels when the absolute serum Free Light chain (sFLC) is ≥100 mg/l and an abnormal sFLC K/λ ratio (<0.26 and >1.65) is found (Dispenzieri, 2008).
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
  • Adequate bone marrow function within 5 days prior to 1st drug intake (cycle1, day 1, C1D1), without transfusion nor growth factor support within 5 days prior to 1st drug intake, defined as: Absolute neutrophils ≥ 1000/mm3 ; Platelets ≥ 50000/mm3 ; Haemoglobin ≥ 8.5g/dl
  • Adequate organ function defined as: Serum creatinine clearance (MDRD formula) ≥30 ml/min ; Serum SGOT or SGPT < 3.0 X upper limit of normal (ULN) ; Serum total bilirubin < 1.5 ULN
  • Wash out period of at least 2 weeks from previous antitumor therapy or any investigational treatment or 5 half-lives from previous antibodies.
  • Women who are partners of men and of childbearing potential must be practicing one of the following methods of birth control: subcutaneous hormonal implant, levonorgestrel releasing intra-uterine system, medroxyprogesterone acetate depot, tubal sterilization, ovulation inhibitory progesterone only pills, or sexual intercourse with a vasectomized male partner (vasectomy must be confirmed by 2 negative semen analyses). Or women will commit to absolute and continuous abstinence confirmed to her physician on a monthly basis. Childbearing potential*. Contraception will start during therapy including dose interruptions, for 4 months after discontinuation of Ixazomib and Daratumumab.
  • Criteria for women of childbearing potential:
  • This protocol defines a female of childbearing potential as a sexually mature woman who:
  • has not undergone a hysterectomy or bilateral oophorectomy or
  • has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months)
  • A woman of childbearing potential must have 2 negative serum or urine pregnancy tests at Screening, first within 28 days prior to dosing and the second within 48 hours prior to dosing, and remain on a highly effective method of birth control. The two methods of reliable contraception must include one highly effective method and one additional effective (barrier) method. FCBP must be referred to a qualified provider of contraceptive methods if needed. The following are examples of highly effective and additional effective methods of contraception:
  • Highly effective methods: Intrauterine device (IUD) ; Hormonal (birth control pills, injections, implants) ; Tubal ligation ; Partner's vasectomy
  • Additional effective methods: Male condom ; Diaphragm CervicalCap
  • Serum (urine in the case where serum is not possible in a timely manner) pregnancy test to be performed for all women of childbearing potential regularly during the study, In addition, a pregnancy test may be done at any time during the study at the discretion of the investigator if a subject misses a period or has unusual menstrual bleeding.
  • A woman of childbearing potential must remain on a highly effective method of birth control. Contraception must begin 4 weeks before initiating treatment with Ixazomib and Daratumumab, during therapy, during dose interruptions and continuing for 4 months following discontinuation of Ixazomib and Daratumumab. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy.
  • A man who has not had a vasectomy and who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control eg, condom with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study, for 4 months following discontinuation of Ixazomib and Daratumumab. The exception to this restriction is that if the subject's female partner is surgically sterile, a second method of birth control is not required.

Who cannot join

  • Target disease exceptions: Solitary bone/solitary extramedullary plasmocytoma ; Patients with non-secretory MM and non-measurable MM ; Evidence of central nervous system (CNS) involvement
  • Medical history and Concurrent disease:
  • Subjects with prior (≤ 5 years) or concurrent invasive malignancies except the following: Adequately treated basal cell or squamous cell skin cancer ; Incidental finding of low grade (Gleason 3+3 or less) prostate cancer ; Any cancer from which the subject has been disease free for at least 3 years.
  • Subject with known/underlying medical conditions that, in the investigator's opinion would make the administration of the study drug hazardous (ie: uncontrolled diabetes or uncontrolled coronary artery disease)
  • Any uncontrolled or severe cardiovascular or pulmonary disease determined by the investigator including: NYHA functional classification III or IV congestive heart failure LVEF (Left Ventricular Ejection Fraction) ≥45% ; Uncontrolled angina, hypertension or arrhythmia Myocardial infarction in the past 6 months
  • Subjects with grade 2 or greater peripheral neuropathy (as per NCI-CTCAEv4.0)
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  • Subject is a woman who is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 4 months after the last dose of any component of the treatment regimen. Or, subject is a man who plans to father a child while enrolled in this study or within 4 months after the last dose of any component of the treatment regimen.
  • Known positive for HIV or active hepatitis B or C.
  • Subjects with psychiatric illnesses or social situations that would preclude them understanding the informed consent, study compliance or the ability to tolerate study procedures and/or study therapy
  • Subjects with known chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) < 50% of predicted normal. Note that FEV1 testing is required for patients suspected of having COPD and subjects must be excluded if FEV1 <50% of predicted normal.
  • Subjects with a history of moderate or severe persistent asthma within the past 2 years (see appendix), or with uncontrolled asthma of any classification at the time of screening (Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study).
  • Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of Ixazomib including difficulty swallowing.
  • Physical and laboratory test findings:
  • Patients on dialysis or with a Creatinine clearance < 30mL/min
  • SGOT or SGPT >3ULN
  • Prohibited prior therapies
  • Prior local irradiation within two weeks before first dose
  • Previous anti-CD38 therapy.
  • Previous Ixazomib therapy
  • Allergies and Adverse Drug Reaction:Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
  • Refusal to consent or protected by a legal regime (guardianship, trusteeship)

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU CAEN Dept of Hematology

    Caen, 14033

Other trials in France

About this study

Official title: A Multicentre Open-label Phase II Study of Ixazomib -Daratumumab Without Dexamethasone (IDara) in Elderly Relapse Refractory Multiple Myeloma

Multiple myeloma is an incurable hematological malignancy that affects older patients. Currently, despite recent progress, the disease relapses more or less quickly after initial treatment and requires the resumption of treatment with new drugs associated with cortisone, whose side effects are important. The investigators propose to conduct a phase 2 testing the combination ixazomib - daratumumab without dexamethasone.

Being tested
Ixazomib and Daratumumab
Keywords
Multiple Myeloma
Medical subject headings
Multiple Myeloma

What participants receive

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

  • Ixazomib and DaratumumabCombination product

    Daratumumab will be administrated every week for the first 2 cycles. For cycle 3 to 6, it will be administrated every two weeks at day 1 and day 15. From cycle 7 until progression Daratumumab will be administrated every 4 weeks.

    Ixazomib will be administrated every week three weeks on one week off at D1, D8 and D15 on a 28-d cycle basis.

    Dexamethasone will not be given except one series of 4 days of dexamethasone, 20 mg/day or a maximum of 80 mg, for emergencies and complications at initiation of treatment.

Study groups in NCT03757221
Study groupRoleWhat they receive
Combination ixazomib + daratumumab without dexamethasoneExperimentalElderly Relapse Refractory Multiple Myeloma Patients treated by Combination ixazomib + daratumumab without dexamethasone
Receives: Combination Product: Ixazomib and Daratumumab

What is being measured

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

  1. Very Good Partial Response (VGPR) + Complete Response (CR) Rate using the IMWG response criteria

    The primary endpoint is the Very Good Partial Response (VGPR) + Complete Response (CR) Rate using the IMWG response criteria. Using IMWG criteria for best response reached at during the twelve months follow-up.

    Measured: 12 months

Timeline

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

  1. First posted28 Nov 2018
  2. Study start7 Feb 2019
  3. Primary completion15 Sep 2022
  4. Study completion28 Apr 2024

Why it stopped: Early termination (regarding the follow-up of the patients). The required sample size was reached, and the primary endpoint was met.

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
Model description
We plan a single-arm non-randomized open label phase II study with a Fleming one stage hypothesis testing for the primary endpoint of VGPR (Very Good Partial Response) + CR (Complete Response) Rate during the twelve months follow-up. The efficacy of Daratumumab plus Ixazomib will be evaluated in comparison to a minimally effective lower threshold level of VGPR + CR.
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03757221
Sponsor's protocol ID
18-070
Acronym
IDARA
Status last verified
May 2026
First submitted
27 Nov 2018
Last updated
13 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bobin A, Macro M, Touzeau C, Mariette C, Manier S, Brechignac S, Vincent L, Hebraud B, Decaux O, Schulman S, Lenoir C, Godmer P, Parienti JJ, Paul LPS, Briant A, Leleu X. A dexamethasone-free daratumumab-ixazomib regimen in frail elderly patients with relapsed or refractory multiple myeloma: Results of the IFM 2018-02 phase II study. Br J Haematol. 2026 Jul;209(1):127-135. doi: 10.1111/bjh.70512. Epub 2026 May 7.

    PubMed 42097596

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ixazomib and Daratumumab in people with Multiple Myeloma, run by University Hospital, Caen at 1 site 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 32 inclusion and 21 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: stopped early, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study was stopped early (reason given: Early termination (regarding the follow-up of the patients). The required sample size was reached, and the primary endpoint was met.). Results are not available in the source record.

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?

Very Good Partial Response (VGPR) + Complete Response (CR) Rate using the IMWG response criteria (time frame: 12 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 NCT03757221, which also lists 1 linked publication.

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 13 May 2026.

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