Clinical Trials

Inclusion Criteria:

• Male or female age ≥ 18 years.
• Prior diagnosis of multiple myeloma (MM) according to International Myeloma Working Group (IMWG) criteria, and measurable disease.
• Relapsed to at least one IMiD, one PI, and one anti-CD38 antibody; patient does not need to be refractory to all three classes of treatment in the same LOT in order to be eligible.
  • Note:  Refractory is defined as having progressive disease (PD) while on therapy or within 60 days following treatment.
  • Note:  PD will be defined as one or more of the following based on the 2016 IMWG consensus criteria for response and minimal residual disease assessment in MM7:
• Relapsed or refractory to last anti-MM regimen.
• Receiving subsequent treatment after becoming TCR (but not necessarily the first subsequent treatment). The index date will be defined as the date when a TCR-identified and eligible patient receives their next LOT (i.e., systemic cancer treatment or anti-cancer regimen). This means that the index therapy will not be restricted to the first LOT following TCR eligibility.
• Ability to understand the study procedures and provide written informed consent.

Exclusion Criteria:

• Individual < 18 years.
• No smoldering MM, active plasma cell leukemia, systemic amyloid light chain amyloidosis, POEMS syndrome.
• No stem cell transplant within 12 weeks prior to study enrollment or active GVHD.
• No other active malignancy within 3 years prior to study enrollment.
  • Note: Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  • Note: If there is a history of prior malignancy, they must not be receiving other specific treatment (hormone therapy, chemotherapy, or immunotherapy) for their cancer
• No investigational drug within 30 days or 5 half-lives preceding the index date, and throughout course of the study.
• No live attenuated vaccine administered 4 weeks prior to study enrollment.
• No active hepatitis B virus (HBV), hepatitis C virus (HCV), severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), human immunodeficiency virus (HIV), or uncontrolled infection. Active infections must be resolved at least 14 days prior to study enrollment.
• No impaired cardiovascular function or clinically significant cardiovascular diseases (CVD), defined as any of the following within 6 months prior to study enrollment:
  • Acute myocardial infarction (AMI) or acute coronary syndromes (e.g., unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, symptomatic pericardial effusion);
  • Clinically significant cardiac arrhythmias (e.g., uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);
  • Thromboembolic or cerebrovascular events (e.g., transient ischemic attack, cerebrovascular accident, deep vein thrombosis [unless associated with a central venous access complication] or pulmonary embolism);
  • Prolonged QT syndrome (or triplicate average QTcF > 470 msec at screening).
• No ongoing Grade > 2 peripheral sensory or motor neuropathy.
• Pending sufficient sample size, criteria will be applied among patients with prior BCMA-directed therapy:
  • No history of any grade peripheral sensory or motor neuropathy.
  • No history of GBS or GBS variants, or history of any Grade >3 peripheral motor polyneuropathy.
  • No surgical (including major surgery within 14 days prior to study enrollment), medical or psychiatric conditions including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the individual inappropriate for the study.
  • No prior or concomitant treatment with an anti-BCMA bispecific antibody, including elranatamab.
    • Note: Additional inclusion/exclusion criteria may be applied in a sensitivity analysis to more closely match the Phase 2 MagnetisMM-3 (study C1071003) trial population depending on available data.
• The following information will be collected at the time of enrollment to the extent data are available. Laboratory measurements will be based on the most recent reading at the time of enrollment:
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
  • Left ventricular ejection fraction (LVEF) > 40% by a MUGA scan or ECHO;
  •  Adequate hepatic function o Total bilirubin < 2 x upper limit of normal (ULN) (< 3 x ULN if documented Gilbert’s syndrome);
  • Aspartate transaminase (AST) < 2.5 x ULN;
  • Alanine aminotransferase (ALT) < 2.5 x ULN;
  • Adequate renal function o Creatinine clearance > 30 mL/min (according to the Cockcroft Gault formula, by 24-hour urine collection for creatinine clearance, or according to local institutional standard method;
  • Adequate bone marrow function;
  • Absolute neutrophil count (ANC) > 1.0 x 10^9 /L;
  • Platelets > 25 x 10^9 /L;
  • Hemoglobin > 8 g/dL;
  • Resolved acute effects of any prior therapy to baseline severity or Common Terminology Criteria for Adverse Events (CTCAE) Grade < 1.

Eligibility last updated 9/1/21. Questions regarding updates should be directed to the study team contact.