Trial Title:
Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma
NCT ID:
NCT05572229
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Lenalidomide
Daratumumab
Conditions: Keywords:
Newly diagnosed Multiple Myeloma
Elderly patients
Teclistamab
Daratumumab
Lenalidomide
Toxicity
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Teclistamab
Description:
Teclistamab will be administered via a subcutaneous injection (SC)
Arm group label:
Tec-Dara
Arm group label:
Tec-Len
Other name:
JNJ-64007957
Intervention type:
Drug
Intervention name:
Daratumumab
Description:
Daratumumab will be administered via a subcutaneous injection (SC)
Arm group label:
Tec-Dara
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
Lenalidomide will be administered orally
Arm group label:
Tec-Len
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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
2. Have an ECOG performance status score of 0-2
3. Not considered for high-dose chemotherapy and autologous SCT
4. Have clinical laboratory values meeting the criteria during the Screening Phase.
5. 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.
Exclusion Criteria:
Medical Conditions
1. CNS involvement or clinical signs of meningeal involvement of multiple myeloma. If
either is suspected, negative whole brain MRI and lumbar cytology are required.
2. Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome
(polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or
primary light chain amyloidosis.
3. Any ongoing myelodysplastic syndrome or B cell malignancy (other than multiple
myeloma).
4. Any history of malignancy, other than multiple myeloma, which is considered at high
risk of recurrence requiring systemic therapy
5. Any active malignancies (ie, progressing or requiring treatment change in the last
24 months) other than multiple myeloma.
6. Stroke, transient ischemic attack, or seizure within 6 months prior to signing ICF.
7. Presence of the a cardiac conditions.
Tec-Dara-specific
8. 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.
9. 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
10. Radiotherapy within 14 days or focal radiation within 7 days.
11. 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).
12. 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.
13. 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).
14. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to
any study drug or its excipients.
Diagnostic Assessments
15. HIV positive.
16. Hepatitis B infection.
17. Active hepatitis C infection as measured by positive HCV-RNA testing. Other
Exclusions
18. Women of childbearing potential
19. 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.
20. Concurrent medical or psychiatric condition or disease that is likely to interfere
with study procedures or results.
21. Patient plans to father a child while enrolled in this study or within 3 months
after the last dose of study intervention.
22. Person under guardianship, trusteeship or deprived of freedom by a judicial or
administrative decision.
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chu Amiens - Hopital Sud
Address:
City:
Amiens
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Lydia MONTES
Email:
Principal Investigator
Facility:
Name:
Chru Angers
Address:
City:
Angers
Country:
France
Status:
Recruiting
Investigator:
Last name:
Mamoun DIB
Email:
Principal Investigator
Facility:
Name:
Ch D'Avignon
Address:
City:
Avignon
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Centre Hospitalier de La Cote Basque
Address:
City:
Bayonne
Country:
France
Status:
Recruiting
Investigator:
Last name:
Julie GAY
Email:
Principal Investigator
Facility:
Name:
Chu de Besancon
Address:
City:
Besancon
Country:
France
Status:
Recruiting
Investigator:
Last name:
Jean FONTAN
Email:
Principal Investigator
Facility:
Name:
Aphp Hopital Avicenne
Address:
City:
Bobigny
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Thorsten BRAUN
Email:
Principal Investigator
Facility:
Name:
Chu de Caen
Address:
City:
Caen
Country:
France
Status:
Recruiting
Investigator:
Last name:
Margaret MACRO
Email:
Principal Investigator
Facility:
Name:
Chu Dijon Bourgogne
Address:
City:
Dijon
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Jean-Noël BASTIE
Email:
Principal Investigator
Facility:
Name:
Ch de Dunkerque
Address:
City:
Dunkerque
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Hélène DEMARQUETTE
Email:
Principal Investigator
Facility:
Name:
Chu de Grenoble
Address:
City:
La Tronche
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Centre Hospitalier de Versailles
Address:
City:
Le Chesnay
Country:
France
Status:
Recruiting
Investigator:
Last name:
Sophie RIGAUDEAU
Email:
Principal Investigator
Facility:
Name:
Chu de Lille, Hopital Claude Huriez
Address:
City:
Lille
Country:
France
Status:
Recruiting
Investigator:
Last name:
Salomon MANIER
Email:
Principal Investigator
Facility:
Name:
Chu Limoges
Address:
City:
Limoges
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Centre Leon Berard
Address:
City:
Lyon
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Phillipe REY
Email:
Principal Investigator
Facility:
Name:
Chr Metz-Thionville
Address:
City:
Metz
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Véronique DORVAUX
Email:
Principal Investigator
Facility:
Name:
Chu Montpellier
Address:
City:
Montpellier
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Hopital E. Muller- Ghrmsa
Address:
City:
Mulhouse
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Murielle NEWINGER
Email:
Principal Investigator
Facility:
Name:
Chru de Nancy, Hopitaux de Brabois
Address:
City:
Nancy
Country:
France
Status:
Recruiting
Investigator:
Last name:
Caroline JACQUET
Email:
Principal Investigator
Facility:
Name:
Chu de Nantes Site Hotel Dieu
Address:
City:
Nantes
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Aphp - Chu Henri Mondor
Address:
City:
Paris
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Aphp - Hopital Saint Antoine
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Mohamad MOHTY
Email:
Principal Investigator
Facility:
Name:
Aphp - Hopital Saint Louis
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Bertrand ARNULF
Email:
Principal Investigator
Facility:
Name:
Chu Bordeaux
Address:
City:
Pessac
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Cyrille HULIN
Email:
Principal Investigator
Facility:
Name:
Chu de Poitiers
Address:
City:
Poitiers
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Xavier LELEU
Email:
Principal Investigator
Facility:
Name:
Chu de Reims
Address:
City:
Reims
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Sophie GODET
Email:
Principal Investigator
Facility:
Name:
Chu Pontchaillou
Address:
City:
Rennes
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Hopitaux Universitaire de Strasbourg - Hopital Hautepierre
Address:
City:
Strasbourg
Country:
France
Status:
Recruiting
Investigator:
Last name:
Cécile FOHRER-SONNTAG
Email:
Principal Investigator
Facility:
Name:
Oncopole Chu Toulouse
Address:
City:
Toulouse
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Aurore PERROT
Email:
Principal Investigator
Facility:
Name:
Chru Bretonneau
Address:
City:
Tours
Country:
France
Status:
Recruiting
Investigator:
Last name:
Thomas CHALOPIN
Email:
Principal Investigator
Start date:
December 21, 2023
Completion date:
September 2030
Lead sponsor:
Agency:
University Hospital, Lille
Agency class:
Other
Collaborator:
Agency:
Janssen Pharmaceutica N.V., Belgium
Agency class:
Industry
Source:
University Hospital, Lille
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05572229
