EUCTR2021-000202-22-NL招募中1 期
A Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 1 Prior Line of Therapy - MonumenTAL-3
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 810
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
- 性别
- All
入选标准
- •1. =18 years of age.
- •2. Criterion modified per Amendment 2
- •2.1 Documented multiple myeloma as defined by the criteria below:
- •a. Multiple myeloma diagnosis according to the IMWG diagnostic criteria
- •b. Measurable disease at screening as defined by any of the following:
- •1) Serum M-protein level =0.5 g/dL (central laboratory); or
- •2) Urine M-protein level =200 mg/24 hours (central laboratory); or
- •3) Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain =10 mg/dL (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio (central laboratory normal ranges).
- •3.1 Criterion modified per Amendment 2/EEA-2
- •Relapsed or refractory disease as defined below:
- •a. Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria >60 days after cessation of treatment.
- •b. Refractory disease is defined as <25% reduction in M-protein or confirmed progressive disease by IMWG criteria during previous treatment or =60 days after cessation of treatment.
- •4. Received at least 1 prior line of antimyeloma therapy including a PI and lenalidomide. Participants who have received only 1 prior line of antimyeloma therapy must be considered lenalidomide-refractory (ie, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Participants who have received =2 prior lines of antimyeloma therapy must be considered lenalidomide exposed.
- •5. Documented evidence of progressive disease based on investigator’s determination of response by the IMWG criteria on or after their last regimen.
- •6. Have an ECOG performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment.
- •7. Criterion modified per Amendment 2
- •7.1 Have clinical laboratory values as defined in the protocol
- •8. Human immunodeficiency virus-positive participants are eligible if they meet all of the following:
- •- No detectable viral load (ie, <50 copies/mL) at screening
- •- CD4+ count >300 cells/mm3 at screening
- •- No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 6 months of screening
- •- Receiving highly active antiretroviral therapy (HAART). Any changes in HAART due to resistance/progression should occur at least 3 months prior to screening. A change in HAART due to toxicity is allowed up to 4 weeks prior to screening.
- •9. A participant of childbearing potential must have a negative highly sensitive urine or serum (ß human chorionic gonadotropin [ß hCG]) pregnancy test at screening, within 24 hours prior to the start of study treatment, and must agree to further urine or serum pregnancy tests during the study and within 100 days after receiving the last dose of study treatment.
- •10. A participant must be:
- •a. Not of childbearing potential, or
- •b. Of childbearing potential and
- •1) Practicing true abstinence; or
- •2) Have a sole partner who is bilaterally vasectomized; or
- •3) Practicing 2 effective methods of contraception (at least 1 highly-effective, method of contraception). For participants who are of childbearing potential, see protocol Section 6.12.3 for details regarding concomitant use of estrogen containing products and pomalidomide
- •11. A participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for at least 100 day
排除标准
- •1. Criterion modified per Amendment 1
- •1.1 Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients (refer to the talquetamab and daratumumab IB and appropriate prescribing information).
- •2. Disease is considered refractory to an anti-CD38 monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody).
- •3. Prior or concurrent exposure to any of the following, in the specified time frame prior to randomization:
- •a. GPRC5D-directed therapy
- •b. Received prior pomalidomide therapy
- •c. T cell redirection therapy (for example, antibody therapy or BiTE’s) within 3 months
- •d. Gene-modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells) within 3 months
- •e. Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or =5 half-lives, whichever is less
- •f. Investigational vaccine other than SARS CoV-2 vaccine approved/ in use under emergency approval within 4 weeks
- •g. Live, attenuated vaccine within 4 weeks
- •h. Monoclonal antibody therapy within 21 days
- •i. Cytotoxic therapy within 21 days
- •j. PI therapy within 14 days
- •k. IMiD agent therapy within 14 days
- •l. Radiotherapy within 14 days or focal radiation within 7 days
- •4. 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.
- •5. A maximum cumulative dose of corticosteroids to =140 mg of prednisone or equivalent within 14-day period before the first dose of study drug
- •6. Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI and lumbar cytology are required.
- •7. Criterion modified per Amendment 2
- •7.1 Plasma cell leukemia (per IMWG criteria) at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or
- •primary amyloid light chain amyloidosis.
- •8. Criterion modified per Amendment 2
- •8.1 Myelodysplastic syndrome or active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than relapsed/refractory multiple myeloma. The only allowed exceptions are:
- •a. Any history of malignancy other than multiple myeloma, which is considered at high risk of recurrence requiring systemic therapy
- •b. Any ongoing B-cell malignancy or myelodysplastic syndrome
- •c. Any active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than relapsed/refractory multiple myeloma. The only allowed exceptions are malignancies treated within the last 24 months that are considered cured:
- •1) Non-muscle invasive bladder cancer (solitary Ta-PUNLMP or low grade, <3 cm, no CIS)
- •2)Non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone
- •3)Noninvasive cervical cancer
- •4) Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer (anti-antihormonal the
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