Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma

NCT05572229 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: 2022_01742022-001594-31
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 22

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.

Conditions

Multiple Myeloma

Keywords

Newly diagnosed Multiple Myeloma; Elderly patients; Teclistamab; Daratumumab; Lenalidomide; Toxicity

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

Study Arms (2)

Tec-Dara

EXPERIMENTAL

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

Drug: Teclistamab; Drug: Daratumumab

Tec-Len

EXPERIMENTAL

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

Drug: Teclistamab; Drug: Lenalidomide

Interventions

Teclistamab DRUG

Teclistamab will be administered via a subcutaneous injection (SC)

Also known as: JNJ-64007957

Tec-Dara; Tec-Len

Daratumumab DRUG

Daratumumab will be administered via a subcutaneous injection (SC)

Tec-Dara

Lenalidomide DRUG

Lenalidomide will be administered orally

Tec-Len

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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.

Sponsors & Collaborators

• University Hospital, Lille: lead
• Janssen Pharmaceutica N.V., Belgium: collaborator

Study Sites (22)

Chu Amiens - Hopital Sud

Amiens, France

Location

Chru Angers

Angers, France

Location

Ch D'Avignon

Avignon, France

Location

Centre Hospitalier de La Cote Basque

Bayonne, France

Location

Chu de Besancon

Besançon, France

Location

Chu de Caen

Caen, France

Location

Chu Dijon Bourgogne

Dijon, France

Location

Chu de Grenoble

La Tronche, France

Location

Centre Hospitalier de Versailles

Le Chesnay, France

Location

Chu de Lille, Hopital Claude Huriez

Lille, France

Location

Chu Limoges

Limoges, France

Location

Centre Leon Berard

Lyon, France

Location

Chr Metz-Thionville

Metz, France

Location

Chu Montpellier

Montpellier, France

Location

Chru de Nancy, Hopitaux de Brabois

Nancy, France

Location

Chu de Nantes Site Hotel Dieu

Nantes, France

Location

Aphp - Chu Henri Mondor

Paris, France

Location

Chu Bordeaux

Pessac, France

Location

Chu de Poitiers

Poitiers, France

Location

Hopitaux Universitaire de Strasbourg - Hopital Hautepierre

Strasbourg, France

Location

Oncopole Chu Toulouse

Toulouse, France

Location

Chru Bretonneau

Tours, France

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

daratumumab; Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Salomon MANIER, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: 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 (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2032
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

FR (22)