Actively Recruiting
Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma
Led by University Hospital, Lille · Updated on 2025-09-17
74
Participants Needed
29
Research Sites
349 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Lille
Lead Sponsor
J
Janssen Pharmaceutica N.V., Belgium
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 65 years of age or older at the time of consent with documented multiple myeloma
- Diagnosis of multiple myeloma according to IMWG diagnostic criteria
- Measurable disease defined by serum or urine M protein levels or abnormal serum Ig free light chain ratio
- ECOG performance status score of 0 to 2
- Not eligible for high-dose chemotherapy and autologous stem cell transplant
- Clinical laboratory values meet study criteria during screening
- Male patients agree to use condoms with spermicidal agents during the study and for specified periods after last dose
- Male patients agree not to donate sperm during the study and for specified periods after last dose
- Patient (or legally acceptable representative) signs informed consent form
- Willing and able to follow lifestyle restrictions specified in the protocol
You will not qualify if you...
- Central nervous system involvement or meningeal signs of multiple myeloma
- Plasma cell leukemia, Waldenstr�f6m's macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis
- Ongoing myelodysplastic syndrome or B cell malignancy other than multiple myeloma
- History of malignancy other than multiple myeloma with high risk of recurrence requiring systemic therapy
- Active malignancies other than multiple myeloma requiring treatment change within last 24 months
- Stroke, transient ischemic attack, or seizure within 6 months before consent
- Presence of cardiac conditions
- COPD with FEV1 less than 50% predicted normal
- Moderate or severe persistent asthma within past 2 years or uncontrolled asthma
- Radiotherapy within 14 days or focal radiation within 7 days prior to treatment
- Use of corticosteroids equivalent to 140 mg prednisone within 14 days before first dose
- Live attenuated vaccine within 4 weeks before first dose (non-live vaccines allowed)
- Prior therapy for multiple myeloma except short corticosteroid course before consent
- Life-threatening allergies or intolerance to study drugs
- HIV positive
- Hepatitis B infection
- Active hepatitis C infection
- Women of childbearing potential
- Major surgery or significant injury within 2 weeks prior or planned during treatment
- Concurrent medical or psychiatric conditions likely to interfere with study
- Plans to father a child during or within 3 months after study treatment
- Under guardianship or deprived of freedom by judicial or administrative decision
AI-Screening
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Trial Site Locations
Total: 29 locations
1
Chu Amiens - Hopital Sud
Amiens, France
Actively Recruiting
2
Chru Angers
Angers, France
Actively Recruiting
3
Ch D'Avignon
Avignon, France
Active, Not Recruiting
4
Centre Hospitalier de La Cote Basque
Bayonne, France
Actively Recruiting
5
Chu de Besancon
Besançon, France
Actively Recruiting
6
Aphp Hopital Avicenne
Bobigny, France
Not Yet Recruiting
7
Chu de Caen
Caen, France
Actively Recruiting
8
Chu Dijon Bourgogne
Dijon, France
Actively Recruiting
9
Ch de Dunkerque
Dunkirk, France
Active, Not Recruiting
10
Chu de Grenoble
La Tronche, France
Actively Recruiting
11
Centre Hospitalier de Versailles
Le Chesnay, France
Actively Recruiting
12
Chu de Lille, Hopital Claude Huriez
Lille, France
Actively Recruiting
13
Chu Limoges
Limoges, France
Active, Not Recruiting
14
Centre Leon Berard
Lyon, France
Not Yet Recruiting
15
Chr Metz-Thionville
Metz, France
Actively Recruiting
16
Chu Montpellier
Montpellier, France
Actively Recruiting
17
Hopital E. Muller- Ghrmsa
Mulhouse, France
Not Yet Recruiting
18
Chru de Nancy, Hopitaux de Brabois
Nancy, France
Actively Recruiting
19
Chu de Nantes Site Hotel Dieu
Nantes, France
Active, Not Recruiting
20
Aphp - Chu Henri Mondor
Paris, France
Active, Not Recruiting
21
Aphp - Hopital Saint Antoine
Paris, France
Not Yet Recruiting
22
Aphp - Hopital Saint Louis
Paris, France
Not Yet Recruiting
23
Chu Bordeaux
Pessac, France
Actively Recruiting
24
Chu de Poitiers
Poitiers, France
Actively Recruiting
25
Chu de Reims
Reims, France
Not Yet Recruiting
26
Chu Pontchaillou
Rennes, France
Active, Not Recruiting
27
Hopitaux Universitaire de Strasbourg - Hopital Hautepierre
Strasbourg, France
Actively Recruiting
28
Oncopole Chu Toulouse
Toulouse, France
Actively Recruiting
29
Chru Bretonneau
Tours, France
Actively Recruiting
Research Team
S
Salomon MANIER, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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