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New treatment option for Relapse Multiple Myeloma
Official title Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel in Patients With Relapsed/Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT07093554
What this study is testing
What is Talquetamab?
Talquetamab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for relapse multiple myeloma.
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
- This is a single-arm, open-label, phase 1b study evaluating the safety and feasibility of using talquetamab as bridging therapy prior to cilta-cel in patients with relapsed and refractory multiple myeloma (RRMM).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \> 18 years.
- Histologically confirmed diagnosis of multiple myeloma with evidence of progressive disease as defined by the IMWG criteria.
- Have measurable disease, defined as:
- Serum M-protein level ≥ 1.0 g/dL, or
- Urine M-protein level ≥ 200 mg/24 hours, or
You likely can't join if
- Prior treatment:
- Adoptive T-cell therapy (e.g., CAR T-cell therapy) at any time prior to enrollment.
- Bispecific antibody, investigational or approved, irrespective of its target, at any time prior to enrollment.
- Use of talquetamab prior to enrollment.
- Any therapy targeting BCMA or GPRC5D, including but not limited to antibody-drug conjugates and/or monoclonal antibodies.
- Prior allogeneic stem cell transplant at any time.
See the full eligibility criteria
- Age \> 18 years.
- Histologically confirmed diagnosis of multiple myeloma with evidence of progressive disease as defined by the IMWG criteria.
- Have measurable disease, defined as:
- Serum M-protein level ≥ 1.0 g/dL, or
- Urine M-protein level ≥ 200 mg/24 hours, or
- In patients without a measurable M-protein, an involved light chain level ≥ 10 mg/dL and an abnormal free light chain ratio.
- Patient had at least one prior line of therapy (PLOT), including a proteasome inhibitor (PI), an anti-CD38 antibody, and an immunomodulatory drug (IMID).
- Patient meets the requirements for the use of talquetamab, as per the most recent FDA prescription information.
- Patient plans to receive cilta-cel and meets the criteria for commercial use as per the most recent FDA prescription information.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at screening.
- Have the following clinical laboratory values at screening: Adequate bone marrow function: Hemoglobin\ ≥ 8.0 g/dL; Absolute Neutrophil Count\ ≥ 1,000/mcL; Absolute Lymphocyte Count\ ≥ 200/mcL; Platelets\ ≥ 25,000/mm\^3...
- Female patients must meet one of the following:
- Postmenopausal for at least one year before the screening visit, or
- Surgically sterile, or
- If they are of childbearing potential: i. Agree to practice two effective methods of contraception from the time of signing of the informed consent form through three months after the last dose of the study drug, AND...
- Male patients, even if surgically sterilized (i.e., status postvasectomy), must agree to one of the following:
- Practice effective barrier contraception during the entire study treatment period and through 90 days after the last study drug dose, OR
- Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not...
- Ability to understand a written informed consent document, and the willingness to sign it.
- Prior treatment:
- Adoptive T-cell therapy (e.g., CAR T-cell therapy) at any time prior to enrollment.
- Bispecific antibody, investigational or approved, irrespective of its target, at any time prior to enrollment.
- Use of talquetamab prior to enrollment.
- Any therapy targeting BCMA or GPRC5D, including but not limited to antibody-drug conjugates and/or monoclonal antibodies.
- Prior allogeneic stem cell transplant at any time.
- Autologous stem cell transplant within 2 months of date of enrollment.
- High-dose cytotoxic chemotherapy (e.g., DCEP, KD-PACE, D-PACE) within 28 days of the enrollment date.
- Cytotoxic chemotherapy, such as cyclophosphamide, within 14 days of the enrollment date .
- Treatment with a PI, IMID, anti-CD38 antibody, or venetoclax within 7 days of the enrollment date.
- A cumulative dexamethasone dose of ≥ 100 mg within 14 days of the enrollment date .
- Radiation therapy within 7 days of the enrollment date.
- No ongoing Grade ≥ 3 non-hematological adverse events from prior therapy.
- Active central nervous system (CNS) involvement.
- Have plasma cell leukemia (PCL).
- Have unmeasurable disease (oligosecretory or non-secretory myeloma).
- Have concomitant AL amyloidosis.
- Patients with severe cardiac disease.
- Active heart disease with New York Heart Association class III or IV congestive heart failure.
- History of myocardial infarction, unstable angina, placement of drug-eluting or metallic stent, coronary artery bypass graft in the last ≤ 6 months.
- Ejection fraction ≤ 40% on transthoracic echocardiography.
- Severe non-ischemic cardiomyopathy.
- Patients with pulmonary dysfunction requiring continuous supplemental oxygen ≥ 2L/minute.
- Any serious medical condition such as:
- Disabling neurological or psychiatric conditions, including altered mental status, dementia, or any condition that could preclude the use of high-dose steroids and/or accurate assessment of neurotoxicity.
- Any condition that could impair the ability of the subject to receive any of the study drugs.
- Infections:
- No new uncontrolled clinically significant bacterial, viral or fungal infections.
- HIV-positive patients on combination antiretroviral therapy are not eligible.
- Pregnant women are excluded from this study because talquetamab and cilta-cel have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing...
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, United States
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milwaukee, Wisconsin, United States. 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.