Status and phase
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About
The researchers are doing this study to find out whether combining teclistamab and mezigdomide is a safe and effective treatment approach in people with relapsed/refractory multiple myeloma (MM).
Enrollment
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Inclusion criteria
Patients with relapsed or refractory multiple myeloma who has been treated with a proteasome inhibitor, an IMiD, and an anti-CD38 antibody. Patients who have been treated with at least 2 prior lines of therapy are eligible. Multiple myeloma is defined by the International Myeloma Working Group (IMWG) updated criteria.
Patients need to have measurable disease defined by one or more of the following:
Serum myeloma (M)-protein greater than or equal to 0.5 g/dL (5 g/L).
Urine M-protein greater or equal to 200 mg/24 h.
Involved light chain (either kappa or lambda) >10 mg/dL with an abnormal kappa: lambda ratio
Plasmacytoma(s) that is new or definitely increased verified by imaging or biopsy.
Increase is defined as a 50% and at least 1 cm increase as measured serially by the sum of the products of the cross-diameters of the measurable lesion.
A bone marrow biopsy demonstrating >30% infiltration of clonal plasma cells.
Patients who have received prior BCMA-directed therapy > 60 days prior including antibody drug conjugates or chimeric antigen receptor T-cell [CAR T] are eligible. BCMA presence on the cell surface should be confirmed in patients who have been treated with prior BCMA targeted therapies. Prior treatment with BCMA targeted bispecific antibodies is not allowed.
Patients who have received bispecific antibodies >60 days prior with targets other than BCMA are eligible.
Patients who have received allogeneic stem cell transplantation >6 months prior are eligible.
Age ≥18 years.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1. PS-2 is permitted if PS is due solely to bone pain.
Fulfil the criteria for Adequate Organ System Function Based on Safety Assessments:
Hematologic:
Chemistry:
Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1, with the exception of peripheral neuropathy attributable to bortezomib.
Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
° Is not a woman of childbearing potential (WOCBP)
Nonchildbearing potential is defined as follows (by other than medical reasons):
The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy. Pregnancy prevention while on mezigdomide treatment is All WOCBP must agree and adhere to all testing and contraception requirements in the mezigdomide Global Pregnancy Prevention Plan (PPP). Duration of contraception for WOCBP must be in accordance with the mezigdomide Global PPP
Male participants: Male participants are eligible to participate if they agree to the following: male participants must agree to practice complete abstinence or agree to use a condom during sexual contact with a pregnant partner or an WOCBP while taking mezigdomide, during dose interruptions, and for 28 days after the last dose of mezigdomide, even if they have undergone a successful vasectomy (ie, with documented azoospermia 90 days after the procedure). See mezigdomide Global PPP, Appendix 3. Male participants must agree not to donate sperm for the purpose of reproduction during this period.
Signed and dated Informed Consent by study participant.
Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures.
Exclusion criteria
Prior treatment with a BCMA targeted bispecific antibody
Prior treatment with mezigdomide
Systemic anti-myeloma therapy (including systemic steroids) within ≤14 days, or plasmapheresis within 7 days prior to the first dose of study drug.
Use of an investigational drug within 14 days or five half-lives (whichever is longer) preceding the first dose of study drug.
Radiation therapy within ≤14 days prior to study entry (bone lesions requiring radiation may be treated with limited [i.e., ≤ 25% of bone marrow in field] radiation therapy during this period).
Patients with a history of autologous stem cell transplant within 60 days or allogeneic stem cell transplant within 6 months prior to study enrollment.
Patients with primary AL amyloidosis will be excluded.
Participant must not have had major surgery ≤4 weeks prior to initiating study treatment.
Evidence of active internal bleeding.
Presence of active renal condition. Participants with isolated proteinuria resulting from multiple myeloma are eligible, provided they fulfill criteria given
Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease per investigator's assessment).
Subject has active or prior history of malignancy, other than multiple myeloma, unless the subject has been free of the disease or medically stable for ≥ 2 years. The only allowed exceptions are the below listed malignancies treated within the last 24 months and that are considered cured:
Evidence of cardiovascular risk including any of the following:
Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to teclistamab or mezigdomide, or any of the components of the study treatment.
Pregnant or lactating individual.
Active infection requiring treatment.
Participant has known human immunodeficiency virus (HIV) infection, unless the participant can meet all of the following criteria:
Note: Consideration must be given to ART and prophylactic antimicrobials that may have a drug-drug interaction and/or overlapping toxicities with teclistamab or mezigdomide or other combination products as relevant.
Presence of hepatitis B surface antigen (HbsAg), or hepatitis B core antibody (HbcAb at Screening or within 3 months prior to first dose of study treatment). Note: Participants with positive Hepatitis B antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis B DNA test is obtained.
Active Hepatitis C infection as measured by positive hepatitis C virus (HCV)-RNA testing. Subjects with a history of HCV antibody positivity must undergo HCV RNA testing. The result needs to be negative for trial eligibility.
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
Administration of strong CYP3A modulators or proton-pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole) within 2 weeks of starting study treatment.
Primary purpose
Allocation
Interventional model
Masking
18 participants in 1 patient group
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Central trial contact
Saad Usmani, MD, MBA; Malin Hultcrantz, MD, PhD
Data sourced from clinicaltrials.gov
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