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New treatment option for Multiple Myeloma
Official title Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma
ClinicalTrials.gov ID: NCT05572229
What this study is testing
What is Teclistamab?
Teclistamab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for multiple myeloma.
Also referred to as JNJ-64007957.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join 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...
- 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...
You likely can't join 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...
- Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or...
- 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.
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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.
- 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...
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients. Diagnostic Assessments
- HIV positive.
- Hepatitis B infection.
- Active hepatitis C infection as measured by positive HCV-RNA testing. Other Exclusions
- Women of childbearing potential
- 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...
- Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results.
- Patient plans to father a child while enrolled in this study or within 3 months after the last dose of study intervention.
- Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision.
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Avignon, France
- Bayonne, France
- Besançon, France
- Bobigny, France
- Caen, France
- Dijon, France
- Dunkirk, France
- La Tronche, France
- Le Chesnay, France
- Lille, France
- Limoges, France
- Lyon, France
- Metz, France
- Montpellier, France
- Mulhouse, France
- Nancy, France
- Nantes, France
- Paris, France
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; Avignon, France; Bayonne, France; Besançon, France; Bobigny, France and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.