Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma
IFM2021-01
A Phase 2 Study of Teclistamab in Combination With Daratumumab or Lenalidomide in Elderly Patients With Newly Diagnosed Multiple Myeloma
2 other identifiers
interventional
74
1 country
29
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 multiple-myeloma
Started Dec 2023
Typical duration for phase_2 multiple-myeloma
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2022
CompletedFirst Posted
Study publicly available on registry
October 7, 2022
CompletedStudy Start
First participant enrolled
December 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2030
ExpectedSeptember 17, 2025
September 1, 2025
2.3 years
September 27, 2022
September 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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).
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
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
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*
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
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
- +7 more secondary outcomes
Study Arms (2)
Tec-Dara
EXPERIMENTALFor patients assigned to cohort A (Tec-Dara) patients will receive Tec-Dara until documented PD or unacceptable toxicity
Tec-Len
EXPERIMENTALFor patients assigned to cohort B (Tec-Len) patients will receive Tec-Len until documented PD or unacceptable toxicity
Interventions
Teclistamab will be administered via a subcutaneous injection (SC)
Eligibility Criteria
You may qualify if:
- 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
- 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.
- \. 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.
- \. 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.
- \. Must be willing and able to adhere to the lifestyle restrictions specified in this protocol.
You may not qualify if:
- 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.
- 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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Lillelead
- Janssen Pharmaceutica N.V., Belgiumcollaborator
Study Sites (29)
Chu Amiens - Hopital Sud
Amiens, France
Chru Angers
Angers, France
Ch D'Avignon
Avignon, France
Centre Hospitalier de La Cote Basque
Bayonne, France
Chu de Besancon
Besançon, France
Aphp Hopital Avicenne
Bobigny, France
Chu de Caen
Caen, France
Chu Dijon Bourgogne
Dijon, France
Ch de Dunkerque
Dunkirk, France
Chu de Grenoble
La Tronche, France
Centre Hospitalier de Versailles
Le Chesnay, France
Chu de Lille, Hopital Claude Huriez
Lille, France
Chu Limoges
Limoges, France
Centre Leon Berard
Lyon, France
Chr Metz-Thionville
Metz, France
Chu Montpellier
Montpellier, France
Hopital E. Muller- Ghrmsa
Mulhouse, France
Chru de Nancy, Hopitaux de Brabois
Nancy, France
Chu de Nantes Site Hotel Dieu
Nantes, France
Aphp - Chu Henri Mondor
Paris, France
Aphp - Hopital Saint Antoine
Paris, France
Aphp - Hopital Saint Louis
Paris, France
Chu Bordeaux
Pessac, France
Chu de Poitiers
Poitiers, France
Chu de Reims
Reims, France
Chu Pontchaillou
Rennes, France
Hopitaux Universitaire de Strasbourg - Hopital Hautepierre
Strasbourg, France
Oncopole Chu Toulouse
Toulouse, France
Chru Bretonneau
Tours, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Salomon MANIER, MD
University Hospital, Lille
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2022
First Posted
October 7, 2022
Study Start
December 21, 2023
Primary Completion
April 1, 2026
Study Completion (Estimated)
September 1, 2030
Last Updated
September 17, 2025
Record last verified: 2025-09