Phase
Condition
Multiple Myeloma
Cancer
Leukemia
Treatment
Teclistamab
Daratumumab
Lenalidomide
Clinical Study ID
Ages > 65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient must be at least ≥65 years of age at the time of informed consent withdocumented 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 FLCratio
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 personduring the study and for a minimum of 4 weeks after the last dose of lenalidomide orfor a period of 3 months after the last dose of other study treatments, whicheveroccurs 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 malepatient is vasectomized, he still must wear a condom (with or without spermicidalfoam/gel/film/cream/suppository), but his female partner is not required to usecontraception.
A male patient must agree not to donate sperm for the purpose of reproduction duringthe study and for a minimum of 4 weeks after the last dose of lenalidomide or forperiod 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 accordancewith local requirements) indicating that the patient understands the purpose of, andprocedures 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 thisprotocol.
Exclusion
Exclusion Criteria:
Medical Conditions
CNS involvement or clinical signs of meningeal involvement of multiple myeloma. Ifeither 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), orprimary light chain amyloidosis.
Any ongoing myelodysplastic syndrome or B cell malignancy (other than multiplemyeloma).
Any history of malignancy, other than multiple myeloma, which is considered at highrisk 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 forpatients with known or suspected of having COPD or asthma and patients must beexcluded if FEV1 <50% of predicted normal.
Moderate or severe persistent asthma within the past 2 years or uncontrolled asthmaof any classification. Note that FEV1 testing is required for patients known orsuspected 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 prednisonewithin 14-days before the first dose of study drug (does not include pretreatmentmedications).
Received a live, attenuated vaccine within 4 weeks before the first dose of studydrug. 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 shortcourse of corticosteroids prior to signing ICF (not to exceed 40 mg ofdexamethasone, or equivalent per day for a maximum of 4 days, total of 160 mgdexamethasone or equivalent).
Contraindications or life-threatening allergies, hypersensitivity, or intolerance toany study drug or its excipients. Diagnostic Assessments
HIV positive.
Hepatitis B infection.
Active hepatitis C infection as measured by positive HCV-RNA testing. OtherExclusions
Women of childbearing potential
Patient had major surgery or had significant traumatic injury within 2 weeks priorto the start of administration of study treatment, or will not have fully recoveredfrom surgery., or has major surgery planned during the time the patient is expectedto be treated in the study or within 2 weeks after administration of the last doseof study treatment.
Concurrent medical or psychiatric condition or disease that is likely to interferewith study procedures or results.
Patient plans to father a child while enrolled in this study or within 3 monthsafter the last dose of study intervention.
Person under guardianship, trusteeship or deprived of freedom by a judicial oradministrative decision.
Study Design
Connect with a study center
Chu Amiens - Hopital Sud
Amiens,
FranceSite Not Available
Chru Angers
Angers,
FranceActive - Recruiting
Ch D'Avignon
Avignon,
FranceSite Not Available
Centre Hospitalier de La Cote Basque
Bayonne,
FranceActive - Recruiting
Chu de Besancon
Besancon,
FranceActive - Recruiting
Aphp Hopital Avicenne
Bobigny,
FranceSite Not Available
Chu de Caen
Caen,
FranceActive - Recruiting
Chu Dijon Bourgogne
Dijon,
FranceSite Not Available
Ch de Dunkerque
Dunkerque,
FranceSite Not Available
Chu de Grenoble
La Tronche,
FranceSite Not Available
Centre Hospitalier de Versailles
Le Chesnay,
FranceActive - Recruiting
Chu de Lille, Hopital Claude Huriez
Lille,
FranceActive - Recruiting
Chu Limoges
Limoges,
FranceSite Not Available
Centre Leon Berard
Lyon,
FranceSite Not Available
Chr Metz-Thionville
Metz,
FranceSite Not Available
Chu Montpellier
Montpellier,
FranceSite Not Available
Hopital E. Muller- Ghrmsa
Mulhouse,
FranceSite Not Available
Chru de Nancy, Hopitaux de Brabois
Nancy,
FranceActive - Recruiting
Chu de Nantes Site Hotel Dieu
Nantes,
FranceSite Not Available
Aphp - Chu Henri Mondor
Paris,
FranceSite Not Available
Aphp - Hopital Saint Antoine
Paris,
FranceSite Not Available
Aphp - Hopital Saint Louis
Paris,
FranceSite Not Available
Chu Bordeaux
Pessac,
FranceSite Not Available
Chu de Poitiers
Poitiers,
FranceSite Not Available
Chu de Reims
Reims,
FranceSite Not Available
Chu Pontchaillou
Rennes,
FranceSite Not Available
Hopitaux Universitaire de Strasbourg - Hopital Hautepierre
Strasbourg,
FranceActive - Recruiting
Oncopole Chu Toulouse
Toulouse,
FranceSite Not Available
Chru Bretonneau
Tours,
FranceActive - Recruiting
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