Multiple MyelomaPhase 2IFM2021-01NCT05572229
Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma
A Phase 2 study testing Teclistamab, Daratumumab and Lenalidomide in people with Multiple Myeloma, run by University Hospital, Lille at 22 sites in France.
Trial summary
The primary hypothesis of this study is that teclistamab SC in combination with daratumumab SC or lenalidomide will be safe and induce a high rate of VGPR or better in newly diagnosed multiple myeloma patients This is an open-label, multicenter, non-comparative, 2-cohort, 2-stage with interruption of enrollment for an… 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?
- Teclistamab, Daratumumab and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 22 sitesFrance
- Study dates
- 21 Dec 2023to Sep 2032
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient must be at least ≥65 years of age at the time of informed consent with documented multiple myeloma as defined by the criteria below:
- Multiple myeloma diagnosis according to IMWG diagnostic criteria
- Measurable disease at Screening as defined by any of the following:
- Serum monoclonal paraprotein (M-protein) level ³ 0.5 g/dL; or Urine M protein level ³ 200 mg/24 hours; or Serum Ig FLC ³ 10 mg/dL and abnormal serum Ig kappa/lambda FLC ratio
- Have an ECOG performance status score of 0-2
- Not considered for high-dose chemotherapy and autologous SCT
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- Have clinical laboratory values meeting the criteria during the Screening Phase.
- 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 minimum of 4 weeks after the last dose of lenalidomide or for a period of 3 months after the last dose of other study treatments, whichever occurs later. If the male patient's partner is a female of childbearing potential, she must also be practicing a highly effective method of contraception. If the male patient is vasectomized, he still must wear a condom (with or without spermicidal foam/gel/film/cream/suppository), but his female partner is not required to use contraception.
- 7. A male patient must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 4 weeks after the last dose of lenalidomide or for period of 3 months after receiving the last dose of other study treatments, whichever occurs later.
- 8. Must sign an ICF (or their legally acceptable representative must sign in accordance with local requirements) indicating that the patient understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- 9. Must be willing and able to adhere to the lifestyle restrictions specified in this protocol.
Who cannot join
- Medical Conditions
- 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, 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
- Any active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than multiple myeloma.
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- Stroke, transient ischemic attack, or seizure within 6 months prior to signing ICF.
- Presence of the a cardiac conditions.
- Tec-Dara-specific
- COPD with a 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 or 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.
- Prior/Concomitant Therapy
- Radiotherapy within 14 days or focal radiation within 7 days.
- Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within 14-days before the first dose of study drug (does not include pretreatment medications).
- Received a live, attenuated vaccine within 4 weeks before the first dose of study drug. Non-live or non-replicating vaccines authorized for emergency use (eg, COVID-19) are allowed.
- Any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids prior to signing ICF (not to exceed 40 mg of dexamethasone, or equivalent per day for a maximum of 4 days, total of 160 mg dexamethasone or equivalent).
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients.
- Diagnostic Assessments
- HIV positive.
- Hepatitis B infection.
- Active hepatitis C infection as measured by positive HCV-RNA testing. Other Exclusions
- Women of childbearing potential
- 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.
- Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results.
- Patient plans to father a child while enrolled in this study or within 3 months after the last dose of study intervention.
- Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
France22 sites
Chu Amiens - Hopital Sud
Amiens
Chru Angers
Angers
Ch D'Avignon
Avignon
Centre Hospitalier de La Cote Basque
Bayonne
Chu de Besancon
Besançon
Chu de Caen
Caen
Chu Dijon Bourgogne
Dijon
Chu de Grenoble
La Tronche
Centre Hospitalier de Versailles
Le Chesnay
Chu de Lille, Hopital Claude Huriez
Lille
Chu Limoges
Limoges
Centre Leon Berard
Lyon
Chr Metz-Thionville
Metz
Chu Montpellier
Montpellier
Chru de Nancy, Hopitaux de Brabois
Nancy
Chu de Nantes Site Hotel Dieu
Nantes
Aphp - Chu Henri Mondor
Paris
Chu Bordeaux
Pessac
Chu de Poitiers
Poitiers
Hopitaux Universitaire de Strasbourg - Hopital Hautepierre
Strasbourg
Oncopole Chu Toulouse
Toulouse
Chru Bretonneau
Tours
About this study
Official title: A Phase 2 Study of Teclistamab in Combination With Daratumumab or Lenalidomide in Elderly Patients With Newly Diagnosed Multiple Myeloma
The primary hypothesis of this study is that teclistamab SC in combination with daratumumab SC or lenalidomide will be safe and induce a high rate of VGPR or better in newly diagnosed multiple myeloma patients
This is an open-label, multicenter, non-comparative, 2-cohort, 2-stage with interruption of enrollment for an efficacy and safety interim analysis, interventional Phase 2 study evaluating the efficacy and safety of a combination with Tec-Dara (Cohort A) or Tec-Len (Cohort B) in patients with newly diagnosed multiple myeloma who are not eligible for SCT.
- Conditions
- Multiple Myeloma
- Being tested
- Teclistamab, Daratumumab, Lenalidomide
- Keywords
- Newly diagnosed Multiple Myeloma, Elderly patients, Teclistamab, Daratumumab, Lenalidomide, Toxicity
- 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 JNJ-64007957
Teclistamab will be administered via a subcutaneous injection (SC)
DaratumumabDrug
Daratumumab will be administered via a subcutaneous injection (SC)
LenalidomideDrug
Lenalidomide will be administered orally
| Study group | Role | What they receive |
|---|---|---|
| Tec-Dara | Experimental | For patients assigned to cohort A (Tec-Dara) patients will receive Tec-Dara until documented PD or unacceptable toxicity Receives: Drug: Teclistamab; Drug: Daratumumab |
| Tec-Len | Experimental | For patients assigned to cohort B (Tec-Len) patients will receive Tec-Len until documented PD or unacceptable toxicity Receives: Drug: Teclistamab; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of very good partial response (VGPR) or better according to the IMWG criteria in patients with newly diagnosed multiple myeloma after 4 cycles of treatment with Tec-Dara or Tec-Len
Measured: At the end of 4 th cycle (each cycle is 28 days), an average 4 months
Secondary outcomes (12)
Treatment-emergent adverse events according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 5.0).
Measured: From date of randomization until the date of first documented progression,assessed up to 5 years
Overall response rate(PR or better) as defined by the IMWG response criteria
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Very good partial response or better, defined as VGPR or CR according to the IMWG criteria at the time of data cutoff
Measured: TFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Complete response or better, defined as negative immunofixation of serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow*
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Time to response
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Duration of response
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Time from randomization to discontinuation of therapy for any reason including death, progression or toxicity
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Overall survival time
OS, measured from the date of the first dose of study treatment to the date of the patient's death. If the patient is alive or the vital status is unknown at last contact, then the patient's data will be censored at the date the patient was last known to be alive
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
TTTF, defined as the time from the date of the first dose of study treatment to discontinuation of therapy for any reason including death, progression, toxicity
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
TTNT, defined as the time from date of the first dose of study treatment to the start of the next-line treatmentTime-to-next treatment
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Rate of minimal residual disease (MRD)-negativity (at level of 10-5 and 10-6 by NGS) at 6 months
Measured: at 6 months
Rate of Sustained MRD-negativity-(at level of 10-5 and 10-6 by NGS)
Measured: at 18 months (12 months after the initial MRD time point).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start21 Dec 2023
- Primary completionJun 2027 (estimated)
- Study completionSep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceutica N.V., Belgium
- Responsible party
- Sponsor
- Investigators
- Salomon MANIER, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572229
- Sponsor's protocol ID
- 2022_0174
- Other IDs
- 2022-001594-31
- Acronym
- IFM2021-01
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2022
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Teclistamab in Combination With Daratumumab or Lenalidomide in Elderly Patients With Newly Diagnosed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05572229
- Acronym / sponsor ID
- IFM2021-01 / 2022_0174
- Conditions
- Multiple Myeloma
- Keywords
- Newly diagnosed Multiple Myeloma, Elderly patients, Teclistamab, Daratumumab, Lenalidomide, Toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Janssen Pharmaceutica N.V., Belgium
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2032 (estimated)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary hypothesis of this study is that teclistamab SC in combination with daratumumab SC or lenalidomide will be safe and induce a high rate of VGPR or better in newly diagnosed multiple myeloma patients
This is an open-label, multicenter, non-comparative, 2-cohort, 2-stage with interruption of enrollment for an efficacy and safety interim analysis, interventional Phase 2 study evaluating the efficacy and safety of a combination with Tec-Dara (Cohort A) or Tec-Len (Cohort B) in patients with newly diagnosed multiple myeloma who are not eligible for SCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tec-Dara | Experimental | Drug: Teclistamab, Drug: DaratumumabFor patients assigned to cohort A (Tec-Dara) patients will receive Tec-Dara until documented PD or unacceptable toxicity |
| Tec-Len | Experimental | Drug: Teclistamab, Drug: LenalidomideFor patients assigned to cohort B (Tec-Len) patients will receive Tec-Len until documented PD or unacceptable toxicity |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Patient must be at least ≥65 years of age at the time of informed consent with documented multiple myeloma as defined by the criteria below:
- Multiple myeloma diagnosis according to IMWG diagnostic criteria
- Serum monoclonal paraprotein (M-protein) level ³ 0.5 g/dL; or Urine M protein level ³ 200 mg/24 hours; or Serum Ig FLC ³ 10 mg/dL and abnormal serum Ig kappa/lambda FLC ratio
- Have an ECOG performance status score of 0-2
- Not considered for high-dose chemotherapy and autologous SCT
Key exclusion criteria (26 listed)
- Medical Conditions
- 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, 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeclistamabAlso: JNJ-64007957Teclistamab will be administered via a subcutaneous injection (SC) | Drug | Tec-Dara, Tec-Len |
| DaratumumabDaratumumab will be administered via a subcutaneous injection (SC) | Drug | Tec-Dara |
| LenalidomideLenalidomide will be administered orally | Drug | Tec-Len |
Primary outcome
Rate of very good partial response (VGPR) or better according to the IMWG criteria in patients with newly diagnosed multiple myeloma after 4 cycles of treatment with Tec-Dara or Tec-Len
Time frame: At the end of 4 th cycle (each cycle is 28 days), an average 4 months
12 secondary outcomes
Treatment-emergent adverse events according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 5.0).
Time frame: From date of randomization until the date of first documented progression,assessed up to 5 years
Overall response rate(PR or better) as defined by the IMWG response criteria
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Very good partial response or better, defined as VGPR or CR according to the IMWG criteria at the time of data cutoff
Time frame: TFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Complete response or better, defined as negative immunofixation of serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow*
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Time to response
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Duration of response
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Time from randomization to discontinuation of therapy for any reason including death, progression or toxicity
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Overall survival time
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
TTTF, defined as the time from the date of the first dose of study treatment to discontinuation of therapy for any reason including death, progression, toxicity
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
TTNT, defined as the time from date of the first dose of study treatment to the start of the next-line treatmentTime-to-next treatment
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Rate of minimal residual disease (MRD)-negativity (at level of 10-5 and 10-6 by NGS) at 6 months
Time frame: at 6 months
Rate of Sustained MRD-negativity-(at level of 10-5 and 10-6 by NGS)
Time frame: at 18 months (12 months after the initial MRD time point).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salomon MANIER, MD principal investigator
University Hospital, Lille
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teclistamab, Daratumumab and Lenalidomide in people with Multiple Myeloma, run by University Hospital, Lille at 22 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 11 inclusion and 26 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 very good partial response (VGPR) or better according to the IMWG criteria in patients with newly diagnosed multiple myeloma after 4 cycles of treatment with Tec-Dara or Tec-Len (time frame: At the end of 4 th cycle (each cycle is 28 days), an average 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2026.