{
  "topic": {
    "stem": "ELRANATAMAB_MM_REVIEW",
    "name": "Elranatamab (BCMA bispecific) in R/R MM",
    "ncts": [
      "NCT03269136",
      "NCT04649359",
      "NCT05020236"
    ],
    "drug_patterns": [
      "elranatamab",
      "pf-06863135"
    ],
    "condition_patterns": [
      "multiple myeloma"
    ]
  },
  "trials": [
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT03269136",
        "aact_title": "PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma",
        "aact_acronym": "",
        "start_date": "2017-11-29",
        "primary_completion_date": "2024-01-19",
        "aact_intvs": [
          "PF-06863135 monotherapy IV or SC",
          "PF-06863135 + dexamethasone",
          "PF-06863135 + lenalidomide",
          "PF-06863135 + pomalidomide"
        ],
        "aact_conditions": [
          "multiple myeloma"
        ],
        "pmid": "40826257",
        "pubmed_year": 2025,
        "pubmed_doi": "10.1007/s11523-025-01168-y",
        "aact_per_arm_counts": {
          "BG000": 2,
          "BG001": 3,
          "BG002": 2,
          "BG003": 3,
          "BG004": 2,
          "BG005": 5,
          "BG006": 6,
          "BG007": 6,
          "BG008": 4,
          "BG009": 4,
          "BG010": 4,
          "BG011": 6,
          "BG012": 6,
          "BG013": 7,
          "BG014": 13,
          "BG015": 4,
          "BG016": 9,
          "BG017": 15
        },
        "aact_primary_outcome_measure": "Part 1: Number of Participants With Drug Limiting Toxicities (DLTs) Graded According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v)4.03",
        "aact_outcome_count_rows": [
          [
            "OG007",
            "4.0"
          ],
          [
            "OG001",
            "2.0"
          ],
          [
            "OG013",
            "14.3"
          ],
          [
            "OG014",
            "46.2"
          ],
          [
            "OG006",
            "1.0"
          ],
          [
            "OG001",
            "0.0"
          ],
          [
            "OG002",
            "0.0"
          ],
          [
            "OG003",
            "0.0"
          ],
          [
            "OG004",
            "0.0"
          ],
          [
            "OG005",
            "1.0"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT04649359",
        "aact_title": "MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb",
        "aact_acronym": "",
        "start_date": "2021-02-02",
        "primary_completion_date": "2022-06-17",
        "aact_intvs": [
          "Elranatamab (PF-06863135)"
        ],
        "aact_conditions": [
          "multiple myeloma"
        ],
        "pmid": "40830740",
        "pubmed_year": 2025,
        "pubmed_doi": "10.1007/s11523-025-01170-4",
        "aact_per_arm_counts": {
          "BG000": 123,
          "BG001": 64
        },
        "aact_primary_outcome_measure": "Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) as Per International Myeloma Working Group (IMWG) Criteria",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "61.0"
          ],
          [
            "OG001",
            "34.4"
          ],
          [
            "OG000",
            "38.5"
          ],
          [
            "OG000",
            "71.4"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT05020236",
        "aact_title": "A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments",
        "aact_acronym": "MAGNETISMM-5",
        "start_date": "2021-10-04",
        "primary_completion_date": "2026-04-27",
        "aact_intvs": [
          "Elranatamab",
          "Daratumumab",
          "Pomalidomide",
          "Dexamethasone"
        ],
        "aact_conditions": [
          "multiple myeloma"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Part 1 Safety Lead-In: Incidence of dose limiting toxicities",
        "aact_outcome_count_rows": []
      }
    }
  ],
  "gate_summary": {
    "A_aact_exists": 3,
    "B_drug_in_intvs": 3,
    "C_condition_in_aact": 3,
    "D_pmid_topic_match": 2,
    "E_two_arms": 2,
    "F_primary_outcome_known": 3
  },
  "n_total": 3,
  "n_pass_all": 2,
  "pass_rate": 0.6666666666666666,
  "verdict": "VIABLE"
}