NL-OMON53994招募中不适用
A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants with Multiple Myeloma - 64407564MMY1004 (monumenTAL-2)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Be >=18 years of age.
- •2. Sign an ICF indicating that the participant understands the purpose of, and
- •procedures required for, the study and is willing to participate in the study,
- •including the requirement to provide information during the Posttreatment
- •Follow-up Period. Consent must be obtained prior to the initiation of any
- •study-related tests or procedures that are not part of standard of care for the
- •participant*s disease.
- •3. Have documented initial diagnosis of multiple myeloma according to IMWG
- •diagnostic criteria.
- •4. Meet treatment regimen-specific requirements as follows:
- •a. Treatment Regimen A (talquetamab + carfilzomib): Participants with multiple
- •myeloma who have received >=3 prior lines of therapy, including a PI, an IMiD,
- •and an anti-CD38 mAb
- •b. Treatment Regimen B (talquetamab + daratumumab + carfilzomib): Participants
- •with multiple myeloma who have received >=3 prior lines of therapy, including a
- •PI and an IMiD
- •c. Treatment Regimen C (talquetamab + lenalidomide): Participants with multiple
- •myeloma who have received >=1 prior lines of therapy,
- •including a PI and an IMiD
- •d. Treatment Regimen D (talquetamab + daratumumab + lenalidomide):
- •o Participants with >=1 prior lines, including a PI and an IMiD.
- •o Participants who are lenalidomide naïve or have newly diagnosed disease. Any
- •newly diagnosed participants must be transplant ineligible. Where local
- •treatment guidelines allow, newly diagnosed transplant-eligible participants
- •who chose to defer ASCT as initial therapy may also be enrolled.
- •e. Treatment Regimen E (talquetamab + pomalidomide): Participants with multiple
- •myeloma who have received >=2 prior lines of therapy, including a PI and
- •lenalidomide
- •5. Have measurable disease at screening as defined by at least 1 of the
- •a. Serum M-protein level >=1.0 g/dL; or
- •b. Urine M-protein level >=200 mg/24 hours; or
- •c. Light chain multiple myeloma: Serum Ig FLC >=10 mg/dL and abnormal serum Ig
- •kappa lambda FLC ratio.
- •6. Have an ECOG performance status score of 0 or 1 at screening and immediately
- •before the start of study treatment administration.
- •7. Have clinical laboratory values meeting the following criteria during the
- •Screening Period:
- •Hemoglobin 8.0 g/dL ( 5 mmol/L) (without prior RBC transfusion within 7 days
- •before the laboratory test; recombinant human erythropoietin use is permitted)
- •Platelets 50×109/L (without transfusion support in the 7 days prior to the
- •laboratory test)
- •ANC 1.0×109/L (prior growth factor support is permitted but must be without
- •support for 7 days if received G-CSF or GM-CSF or 14 days if received peg-G-CSF)
- •AST and ALT <=2.5×ULN
- •Creatinine clearance 30 mL/min based upon Modified Diet in Renal Disease
- •formula calculation (Appendix 7) or a 24-hour urine collection.
- •Total bilirubin <=1.5×ULN; except in participants with congenital bilirubinemia,
- •such as Gilbert syndrome (in which case, direct bilirubin <=1.5×ULN is required)
- •Serum calcium corrected for albumin: <=14 mg/dL (<=3.5 mmol/L) or free ionized
- •calcium <=6.5 mg/dL (<=1.6 mmol/L)
- 另有 5 项未显示
排除标准
- •Any potential participant who meets any of the following criteria will be
- •excluded from participating in the study:
- •1. Prior treatment with any therapy that targets GPRC5D.
- •2. Prior antitumor therapy as follows, in the specified time frame prior to the
- •first dose of study treatment:
- •a. Targeted therapy, epigenetic therapy, or treatment with an investigational
- •drug or an invasive investigational medical device within 21 days or at least 5
- •half lives, whichever is less.
- •b. Gene-modified adoptive cell therapy (eg, CAR modified T-cells, NK cells)
- •within 3 months.
- •c. mAb treatment or bispecific T-cell redirector therapy for multiple myeloma
- •within 21 days.
- •d. Cytotoxic therapy within 21 days.
- •e. PI therapy within 14 days.
- •f. Immunomodulatory agent therapy within 7 days.
- •g. Radiotherapy within 14 days. However, if palliative focal radiation is used,
- •the participant is eligible irrespective of the end date of radiotherapy.
- •3. Live, attenuated vaccine within 4 weeks before the first dose of study
- •4. Non-hematologic toxicity from prior anticancer therapy that has not resolved
- •to baseline levels or to Grade <=1 (except alopecia [any grade] or peripheral
- •neuropathy Grade <=3).
- •5. Received a cumulative dose of corticosteroids equivalent to >=140 mg of
- •prednisone within the 14-day period before the start of study treatment
- •administration
- •6. Received either of the following:
- •a. An allogeneic SCT within 6 months before the first dose of study treatment.
- •Participants who received an allogeneic transplant must be off all
- •immunosuppressive medications during the 6 weeks before the start of study
- •treatment administration without signs of graft-versus-host disease.
- •b. An autologous SCT within 12 weeks before the start of study treatment
- •administration.
- •7. Active CNS involvement or exhibition of clinical signs of meningeal
- •involvement of multiple
- •8. Active plasma cell leukemia (>2.0×109/L plasma cells by standard
- •differential), Waldenstro*m*s macroglobulinemia, POEMS syndrome
- •(polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or
- •primary amyloid light chain amyloidosis.
- •9. Known to be seropositive for human immunodeficiency virus.
- •10. Seropositive for HBV, defined by a positive test for HbsAg. Participants
- •with resolved infection (ie, participants who are HbsAg negative but positive
- •for hepatitis B core antibody[anti-HBc] and/or positive for hepatitis B surface
- •antibody [anti-HBs]) must be screened using real-time PCR measurement of HBV
- •DNA levels. Those who are PCR positive will be excluded. EXCEPTION:
- •Participants with serologic findings suggestive of HBV vaccination (anti-HBs
- •positivity as the only serologic marker) and a known history of prior HBV
- •vaccination do not need to be tested for HBV DNA by PCR.
- •11. Active hepatitis C infection as measured by positive HCV-RNA testing.
- •Participants with a history of HCV antibody positivity must undergo HCV-RNA
- •12. Known allergies, hypersensitivity, or intolerance to any study treatment or
- •their excipients
- 另有 4 项未显示
研究者
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