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Multiple MyelomaPhase 2IFm2022-01NCT06353022

Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma

A Phase 2 study testing Teclistamab, Talquetamab and Lenalidomide in people with Multiple Myeloma, run by Nantes University Hospital at 19 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 2 study, open-label, 2-cohort, multicenter, national, interventional in patients with newly diagnosed multiple myeloma. The study will investigate teclistamab (Tec) in combination with lenalidomide (Len) (Tec-Len; Cohort A) or in combination with talquetamab (Tal) (Tec-Tal; Cohort B), allocated based… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Teclistamab, Talquetamab and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
19 sitesFrance
Study dates
26 Jun 2024to 26 Jun 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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Each potential patient must satisfy all of the following criteria to be enrolled in the study:
  • Age, Type of Patient, Disease Characteristics
  • Male or female patients must be at least 18 years of age at the time of consent younger than 66 years.
  • Documented multiple myeloma satisfying the calcium elevation, renal insufficiency, anemia, and bone lesions (CRAB) criteria and measurable disease (Source: Rajkumar 2014)
  • Newly diagnosed patients eligible for high dose therapy and autologous Stem cell therapy.
  • Have a Karnofsky performance status score ≥50% (Eastern Cooperative Oncology Group ECOG performance status ECOG score ≤2.
Show all 68Show fewer
  • Have clinical laboratory values meeting the following criteria.
  • Sex and Contraceptive/Barrier Requirements
  • A female patient of childbearing potential must have a negative serum pregnancy test within 10 to 14 days prior to the start of study treatment and again either a serum or urine pregnancy test within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study and for a period of 6 months after the last dose of study treatments.
  • A female patient must be :
  • Not of childbearing potential, or
  • Of childbearing potential and 1) Practicing 2 reliable methods of contraception simultaneously including one highly effective method of contraception and one other effective method of contraception starting 4 weeks prior to dosing, throughout the study including during dose interruptions and for period of 6 months after the last dose of study treatments. For patients who are of childbearing potential.
  • A female patient must agree not to donate eggs or freeze for future use, for the purposes of assisted reproduction during the study and for a period of 6 months after the last dose of other study treatments. Female patients should consider preservation of eggs prior to study treatment as anti-cancer treatments may impair fertility.
  • A male patient must wear a condom (with spermicidal foam/gel/film/cream/suppository) when engaging in any activity that allows for passage of ejaculate to another person during the study and for a period of 6 months after the last dose of study treatments. If the male patient's partner is a female of childbearing potential, she must also be practicing a highly effective method of contraception.
  • A male patient must agree not to donate sperm for the purpose of reproduction during the study and for a period of 6 months after receiving the last dose of study. Male patients should consider preservation of sperm prior to study treatment as anti cancer treatments may impair fertility.
  • Informed Consent
  • 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 patient may withdraw consent at any time without prejudice to future medical care.
  • Willing and able to adhere to the lifestyle restrictions specified in this protocol.
  • Affiliation with French social security system or beneficiary from such system.
  • Non inclusion Criteria:
  • Medical Conditions
  • Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the NCI CTCAE Version 5.0.
  • Chronic Obstructive Pulmonary Disease (COPD) with a Forced Expiratory Volume 1 (FEV1) <50% of predicted normal. Note that FEV1 testing is required for patients with known or suspected of having COPD or asthma and patients must be excluded if FEV1 <50% of predicted normal.
  • Moderate or severe persistent asthma within the past 2 years, uncontrolled asthma of any classification. Note that FEV1 testing is required for patients known or suspected asthma and patients must be excluded if FEV1 <50% of predicted normal.
  • Central Nervous System (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI and lumbar cytology are required.
  • Plasma cell leukemia, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis.
  • Any ongoing myelodysplastic syndrome or B cell malignancy (other than multiple myeloma).
  • Any history of malignancy, other than multiple myeloma, which is considered at high risk of recurrence requiring systemic therapy.
  • Active malignancies other than multiple myeloma. The only allowed exceptions are malignancies treated within the last 24 months that are considered cured:
  • Non-muscle invasive bladder cancer.
  • Non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone
  • Noninvasive cervical cancer
  • Localized prostate cancer with a Gleason Score ≤7a, treated locally only
  • Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer
  • Other malignancy that is considered cured with minimal risk of recurrence in consultation with the Sponsor
  • Stroke, transient ischemic attack, or seizure within 6 months prior to signing informed consent form.
  • Presence of the following cardiac conditions:
  • New York Heart Association stage III or IV congestive heart failure
  • Myocardial infarction or coronary artery bypass graft ≤6 months prior to enrollment
  • History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
  • Uncontrolled cardiac arrhythmia or clinically significant ECG (Electrocardiogram) abnormalities
  • History of severe non-ischemic cardiomyopathy
  • Concurrent medical or psychiatric condition or 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, such as:
  • Acute diffuse infiltrative pulmonary disease
  • Evidence of active systemic viral, fungal, or bacterial infection, requiring systemic antimicrobial therapy
  • History of autoimmune disease with the exception of vitiligo, type I diabetes, and prior autoimmune thyroiditis that is currently euthyroid based on clinical symptoms and laboratory testing.
  • Disabling psychiatric conditions, severe dementia, or altered mental status.
  • Any other issue that would impair the ability of the patient to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient or that could prevent, limit, or confound the protocol- specified assessments.
  • History of noncompliance with recommended medical treatments
  • Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug (daratumumab, bortezomib, lenalidomide, dexamethasone, teclistamab or talquetamab) or its excipients or analogues and study-required co-medication.
  • Incidence of gastrointestinal disease that may significantly alter the absorption of oral drugs.
  • Prior/Concomitant Therapy
  • Prior or current systemic therapy or SCT for any plasma cell dyscrasia, with the exception of emergency use of a short course of corticosteroids before treatment.
  • Received a strong CYP3A4 inducer within 5 half-lives prior to the first dose of study treatment (Flockhart 2016: http://medicine.iupui.edu/flockhart/).
  • Plasmapheresis within 28 days prior to the first dose of study treatment.
  • Patient had major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the patient is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment.
  • Taken any disallowed therapies, Concomitant Therapy before the planned first dose of study intervention.
  • Received a live, attenuated vaccine within 4 weeks before the first dose of study drug. Non-live or replicating vaccines authorized for emergency use (eg, COVID-19) are allowed.
  • Diagnostic Assessments
  • HIV infection (positive, history, treatment for HIV).
  • Hepatitis B infection (ie, HBsAg or HBV-DNA positive). In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status.
  • Active hepatitis C infection as measured by positive HCV-RNA testing. Patients with a history of HCV antibody positivity must undergo HCV RNA testing. If a patient with history of chronic hepatitis C infection (defined as both HCV antibody and HCV RNA positive) completed antiviral therapy and has undetectable HCV-RNA 12 weeks following the completion of therapy, the patient is eligible for the study.
  • Other non-inclusions
  • Patients unable to complete baseline next generation sequencing (NGS) evaluation at Screening.
  • Patient is pregnant, a nursing mother, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment.
  • Patient plans to father a child while enrolled in this study or within 6 months after the last dose of study treatment, whichever is later.
  • Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments.
  • Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision.

Who cannot join

None listed.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

France19 sites

  • CH de la Côte Basque

    Bayonne, 64109

  • CHU Caen

    Caen, 14033

  • CHRU DIjon

    Dijon, 21000

  • Chd Vendee

    La Roche-sur-Yon, 85925

  • CHRU LILLE - Hôpital Claude Huriez

    Lille, 59037

  • CHU Limoges

    Limoges, 87000

  • CH Lyon Sud

    Lyon, 69495

  • IPC Marseille Institut Paoli Calmettes

    Marseille, 13009

  • CHU Montpellier

    Montpellier, 34295

  • CHU de Nantes

    Nantes, 44093

  • APHP Hôpital Saint-Antoine

    Paris, 75012

  • APHP Hôpital La Pitié Salpétrière

    Paris, 75013

  • CHU BORDEAUX - Hôpital du Haut Lévêque

    Pessac, 33604

  • CHU Poitiers

    Poitiers, 86000

  • CHRU Rennes - Hôpital de Pontchaillou

    Rennes, 35033

  • CHU de Strasbourg (HUS)

    Strasbourg, 67200

  • CHU Toulouse

    Toulouse, 31059

  • CHU Tours Hôpital Bretonneau

    Tours, 37044

  • CHRU Nancy - Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Official title: Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma: A Phase 2 (IFM 2022-01)

This is a Phase 2 study, open-label, 2-cohort, multicenter, national, interventional in patients with newly diagnosed multiple myeloma. The study will investigate teclistamab (Tec) in combination with lenalidomide (Len) (Tec-Len; Cohort A) or in combination with talquetamab (Tal) (Tec-Tal; Cohort B), allocated based on minimal residual disease (MRD) status (MRD [-] [standard-risk] vs MRD [+] [high-risk] respectively).

The patient population will consist of adults men and women at least 18 years to younger than 66 years of age, who meet eligibility criteria.

Being tested
Teclistamab, Talquetamab, Lenalidomide, Bortezomib, Daratumumab
Keywords
Multiple Myeloma, Newly Diagnosed, Teclistamab, Talquetamab
Medical subject headings
Multiple Myeloma

What participants receive

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

  • TeclistamabDrug

    Also called No more information

    Maintenance therapy wtih teclistamab (administered via SC injections) for finite duration. Teclistamab will be used in 28 day cycles following initial step up doses

  • TalquetamabDrug

    Also called No more information

    Maintenance therapy with talquetamab (administered via SC injections) for finite duration. Talquetamab will be used in 28 day cycles following initial step up doses

  • LenalidomideDrug

    Also called No more information

    Induction therapy with lenalidomide:

    Lenalidomide 25 mg/day oral from Day 1 to Day 21.

    Maintenance therapy lenalidomide (administered orally) for finite duration.

  • BortezomibDrug

    Also called No more information

    Induction therapy with Borthezomib Cycle 1 to 6: Bortezomib 1.3 mg/m² SC twice a week on Days 1, 4, 8 and 11

  • DaratumumabDrug

    Also called No more information

    Induction therapy with Daratumumab Cycle 1 to 6 Daratumumab 1800 mg SC on Days 1, 8, 15, 22 of Cycle 1 and Cycle 2 and on Days 1 and 15 of Cycle 3

  • DexamethasoneDrug

    Also called No more information

    Induction therapy with Dexamethasone:

    cycle 1 to 3 Dexamethasone 40 mg/day oral or IV on Days 1, 8, 15, 22 Cycle 4 to 6 --> Dexamethasone 40 mg/day oral or IV on Days 1, 8, 15, 22

Study groups in NCT06353022
Study groupRoleWhat they receive
Teclistamab and LenalidomideExperimentalPatients treated with Teclistamab and Lenalidomide for finite duration.
Receives: Drug: Teclistamab; Drug: Lenalidomide; Drug: Bortezomib; Drug: Daratumumab; Drug: Dexamethasone
Talquetamab andTeclistamabExperimentalPatients treated with Teclistamab and Talquetamab for finite duration
Receives: Drug: Teclistamab; Drug: Talquetamab; Drug: Lenalidomide; Drug: Bortezomib; Drug: Daratumumab; Drug: Dexamethasone

What is being measured

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

  1. Rate of sustained MRD negativity (NGS, 10^-5)

    Measured: 38 months

  2. Rate of conversion from positive MRD to negative MRD (NGS, 10^-5)

    Measured: 38 months

Secondary outcomes (9)

  1. Number of adverse events

    Measured: 50 months

  2. Rate of sustained MRD negativity (NGS, 10^-6)

    Measured: 38 months

  3. Rate of conversion from positive MRD to negative MRD (NGS, 10^-6).

    Measured: 38 months

  4. Rate of conversion from positive MRD to negative MRD (NGS, 10^-5).

    Measured: 23 months

  5. Number of the death

    Measured: 74 months

  6. Number of responses

    Measured: 50 months

  7. Number of progression-free survival

    Measured: 74 months

  8. Percentage of duration of response

    Measured: 74 months

  9. Percenatge of time to response

    Measured: 74 months

Timeline

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

  1. First posted8 Apr 2024
  2. Study start26 Jun 2024
  3. Primary completion26 Apr 2028 (estimated)
  4. Study completion26 Jun 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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
103 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06353022
Sponsor's protocol ID
RC23_0267
Other IDs
2023-508310-41, 2023
Acronym
IFm2022-01
Status last verified
Mar 2026
First submitted
22 Mar 2024
Last updated
17 Mar 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 Teclistamab, Talquetamab and Lenalidomide in people with Multiple Myeloma, run by Nantes University Hospital at 19 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 68 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 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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?

Rate of sustained MRD negativity (NGS, 10^-5) (time frame: 38 months). The study lists 2 primary outcomes in all. 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 NCT06353022.

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 17 Mar 2026.

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