Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 65 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05572229
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Lille
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Salomon MANIER, MD
Principal Investigator Affiliation University Hospital, Lille
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Arms & Interventions

Arms

Experimental: Tec-Dara

For patients assigned to cohort A (Tec-Dara) patients will receive Tec-Dara until documented PD or unacceptable toxicity

Experimental: Tec-Len

For patients assigned to cohort B (Tec-Len) patients will receive Tec-Len until documented PD or unacceptable toxicity

Interventions

Drug: - Teclistamab

Teclistamab will be administered via a subcutaneous injection (SC)

Drug: - Daratumumab

Daratumumab will be administered via a subcutaneous injection (SC)

Drug: - Lenalidomide

Lenalidomide will be administered orally

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Salomon MANIER, MD

salomon.manier@chru-lille.fr

0320445962

For additional contact information, you can also visit the trial on clinicaltrials.gov.