Trial comparing treatments for Recurrent Multiple Myeloma
Official title Testing the Investigational Medication Combination of Teclistamab and Pomalidomide Compared to the Usual Treatment (Carfilzomib, Pomalidomide, and Dexamethasone) for Patients With Multiple Myeloma Who Have Relapsed Shortly After Treatment
ClinicalTrials.gov ID: NCT07463807
What this study is testing
What is Carfilzomib?
Carfilzomib is an investigational medicine, given as a once-daily IV infusion (through a vein), being studied as a potential treatment for recurrent multiple myeloma.
Also referred to as Carfilnat, CFZ.
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 phase Ib/II trial compares the effect of teclistamab and pomalidomide to standard treatment with carfilzomib, pomalidomide and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement (relapsed). Teclistamab is a bispecific antibody that can bind to two different antigens at the same time.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 10 years
- Which group you join is decided by chance.
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
- Patient must be ≥ 18 years of age
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patient must have an identifiable dominant sequence (clonotype) established based on Adaptive Biotechnologies clonoSEQ® assay for Phase II only
- Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma.
- Tissue biopsy of any bone lesion or extramedullary plasmacytoma if applicable (positive/negative for clonal plasma cells)
See the full eligibility criteria
Who can join
- Patient must be ≥ 18 years of age
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patient must have an identifiable dominant sequence (clonotype) established based on Adaptive Biotechnologies clonoSEQ® assay for Phase II only
- Bone marrow plasmacytosis with ≥ 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma.
- Tissue biopsy of any bone lesion or extramedullary plasmacytoma if applicable (positive/negative for clonal plasma cells)
- Anemia (hemoglobin value of \> 2 g/dL below the lower limit of normal, or a hemoglobin value \< 10 g/dL)
- Hypercalcemia (serum calcium \> 1 mg/dL higher than the upper limit of normal or \> 11 mg/dL)
- Bone disease (one or more osteolytic lesions on skeletal radiography, CT, or FDG-PET/CT)
- Renal dysfunction (creatinine clearance \ 2 mg/dL).
- Clonal bone marrow plasma cells (BMPCs) ≥ 60%
- Involved/uninvolved serum free light chain ratio ≥ 100
- \> 1 focal lesions on magnetic resonance imaging (MRI) studies ≥ 5 mm
- NOTE: Patients with smoldering myeloma (serum m protein ≥ 3 gm/dL or bone marrow plasma cells ≥ 10% or greater plus no evidence of anemia, hypercalcemia, lytic bone lesions or renal dysfunction) and monoclonal...
- Patient must have experienced relapse disease defined as relapse after one line of lenalidomide therapy including single agent lenalidomide or lenalidomide/dexamethasone or CD38 antibody/lenalidomide +/- dexamethasone.
- Patient must have received no more than two lines of IMWG defined therapy (induction +/- transplant + maintenance is considered a single line of therapy)
- Patient must not receive non-protocol concurrent chemotherapy for the study disease, or any ancillary therapy considered investigational while participating in the study
- Patient must have received an immunomodulatory drug (lenalidomide) and a CD38 antibody (daratumumab or isatuximab)
- ≥ 0.5 g/dL monoclonal protein (M-protein) on serum protein electrophoresis
- ≥ 200 mg/24 hrs of monoclonal protein (M-protein) on a 24-hour urine protein electrophoresis
- Involved free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio (\ 1.65)
- Exception: patients without measurable disease in the serum or urine, but with bone or soft tissue plasmacytoma(s) ≥ 2 cm or who have bone marrow plasma cells ≥ 30% are eligible on study
- NOTE: Urine protein electrophoresis (UPEP) (on a 24 hour collection) is required, no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is ≥ 200 mg/24 hr.
- Patient must not be known to be refractory to carfilzomib or pomalidomide
- Patient must not have received a prior BCMA therapy
- Patient must not be pregnant due to the potential harm to an unborn fetus with the treatment regimens being used
- All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration/randomization to rule out pregnancy.
- Has achieved menarche at some point
- Has not undergone a hysterectomy or bilateral oophorectomy
- Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive...
- Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 6...
- Patient must agree to not breastfeed while on protocol treatment due to the potential risk for adverse events in nursing infants, and must agree to continue not breastfeeding for an additional 5 months after the last...
- Patient must agree to abstain for donating eggs (ova, oocytes) while on study treatment and for 6 months after the last dose of Arm A, B or C protocol treatment
- Patient must agree to abstain from donating sperm while on study treatment and for 3 months after the last dose of protocol treatment even if they have had a successful vasectomy
- Patient must agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment
- Patient must not receive non-protocol concurrent chemotherapy, or any ancillary therapy considered investigational while participating in the study
- NOTE: Bisphosphonates are considered supportive care rather than therapy and are thus allowed while on protocol treatment
- Patient must not have peripheral neuropathy \> grade 2 on clinical examination at the time of registration/randomization
- Patient must not have known uncontrolled congestive heart failure (CHF), New York Heart Association (NYHA) class III or IV, uncontrolled hypertension as defined as systolic \> 180 and/or diastolic \> 100, uncontrolled...
- Patient must not have known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients, or known sensitivity to mammalian-derived products
- Patient must have the ability to understand and the willingness to sign a written informed consent document.
- Absolute neutrophil count (ANC) ≥ 1,500/uL (≤ 14 days prior to registration/randomization)
- Platelets ≥ 100,000/uL (≤ 14 days prior to registration/randomization)
- Total bilirubin ≤ 3 x institutional upper limit of normal (ULN) (≤ 14 days prior to registration/randomization)
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) ≤ 3.0 x institutional ULN (≤ 14 days prior to...
- Calculated creatinine clearance ≥ 30 mL/min (≤ 14 days prior to registration/randomization)
- NOTE: Cockcroft-Gault equation should be used to calculate creatinine clearance
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration/randomization are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Patients with past central nervous system (CNS) involvement are eligible if there is no current CNS involvement
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, 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, but confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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?
This study is enrolling now at Duarte, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.