A Study of Elranatamab Outpatient Administration in Patients With Relapsed/Refractory Multiple Myeloma

Recruiting now · Phase 2

Conditions studied: Multiple Myeloma (MM), Multiple Myeloma Refractory, Multiple Myeloma in Relapse, Multiple Myeloma

In brief

This is a Phase II, open-label, nonrandomized, single-arm study of elranatamab that will be administered in the outpatient setting in 2 sequential cohorts of participants with relapsed or refractory multiple myeloma (RRMM). The primary objective of this study is to evaluate the overall incidence of cytokine release syndrome (CRS) during Cycle 1 of elranatamab treatment following a single prophylactic dose of tocilizumab.

Key facts

Study ID

NCT07637578

Run by

SCRI Development Innovations, LLC

People needed

46

Starts

2026-08-01

Expected to finish

2030-02-01

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent, according to institutional guidelines, signed and dated by the participant or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses
• At least 18 years-of-age at the time of signature of the ICF
• Has documented diagnosis of MM according to IMWG diagnostic criteria
• Measurable disease at screening, as assessed by local laboratory, defined by any of the following:
• Serum M-protein level ≥0.5 g/dL
• Urine M-protein level ≥200 mg/24 hours
• Light chain MM without measurable M-protein in the serum or the urine: serum free light chain (sFLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
• For participants without measurable disease in the serum, urine, or involved FLC, presence of plasmacytomas (≥2 cm x 1 cm)
• Relapsed and/or refractory MM received ≥1 prior line of therapy and must have been exposed to both lenalidomide and an anti-CD38 monoclonal antibody (in the same or separate prior lines)
• ECOG Performance Status score of 0 or 1
• Human immunodeficiency virus (HIV)-positive participants are eligible if they meet all of the following:
• No detectable viral load (i.e., <50 copies/mL) at screening
• CD4+ count >300 cells/mm3 at screening
• No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections 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 enrollment. A change in HAART due to toxicity is allowed up to 4 weeks prior to enrollment. HAART that could interfere with study treatment is excluded (consult the Medical Monitor for a review of medications prior to enrollment, if needed).
• Adequate organ function, defined as follows:
• Hemoglobin (Hgb) ≥8 g/dL (≥5 mmol/L; without prior red blood cell [RBC] transfusion within 7 days before laboratory testing; recombinant human erythropoietin use is permitted)
• Platelets >50 x109/L
• Absolute neutrophil count (ANC) ≥10.x109/L (prior growth factor support is permitted but must be without support for 7 days for G-CSF or GM-CSF and for 14 days for pegylated G-CSF)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5xupper limit of normal (ULN)
• Estimated glomerular filtration rate (eGFR) ≥30 mL/min based on Modified Diet in Renal Disease (MDRD) 4-variable formula calculation or creatinine clearance measured by 24-hour urine collection
• Total bilirubin <1.5xULN (isolated total bilirubin) ≥1.5xULN with conjugated [direct] bilirubin <1.5xULN is allowed for those participants with known congenital nonhemolytic hyperbilirubinemias)
• Corrected serum calcium ≤14 mg/dL (≤3.5 mmol/L) or free ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L)
• Participants must be able and willing to receive prophylaxis for Varicella zoster virus (VZV) and Pneumocystis jirovecii pneumonia (PJP) as follows:
• VZV prophylaxis (e.g. acyclovir or valacyclovir) must be initiated prior to or on Day 1 of study treatment, continued throughout the treatment period, and maintained for at least 3 months after the final dose

You may not qualify if…

• History of antitumor therapy as follows, before the first dose of study drug
• Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is shorter.
• Monoclonal antibody treatment for MM within 21 days.
• Cytotoxic therapy within 21 days.
• PI therapy within 14 days.
• Immunomodulatory agent therapy within 7 days.
• Radiotherapy within 14 days or focal radiation within 7 days.
• Prior gene modified adoptive cell therapy (e.g., chimeric antigen receptor modified [CAR]-T cells) ≤12 weeks before the first dose of study drug
• Has received any of the following:
• Packed red blood cells within the last 7 days prior to dosing
• Platelet transfusions within the last 7 days prior to dosing
• Live vaccine within 1 month prior to screening or plans to receive a live vaccine during the study
• History of Grade ≥3 CRS or ICANS with prior therapies.
• Current treatment with strong or moderate inducers of cytochrome P450 (CYP) 3A4 (CYP3A4) that cannot be discontinued at least 7 days prior to the start of elranatamab treatment and during the study.
• Has myelodysplastic syndrome or active malignancies (i.e., progressing or requiring treatment change in the last 12 months) other than RRMM. The only allowed exceptions are:
• a. Malignancies treated within the last 12 months and considered at very low risk for recurrence: i. Non-muscle invasive bladder cancer (solitary Ta-PUNLMP or low grade, <3 cm, no CIS).
• ii. Skin cancer (non-melanoma or melanoma). iii. Noninvasive cervical cancer. iv. Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, localized breast cancer and receiving antihormonal agents.
• v. Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (RP/RT/focal treatment).
• b. Other malignancy that is considered at minimal risk of recurrence. In the event of any questions, consult with the Medical Monitor prior to enrolling a participant.
• Has active autoimmune disease or documented history autoimmune disease with exception of vitiligo, type I diabetes mellitus, or prior autoimmune thyroiditis currently euthyroid based on symptoms and labs.
• Has active plasma cell leukemia (≥20% peripheral blood plasma cells and ≥2.0×109/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.
• Any of the following cardiac criteria currently or within the last 6 months:
• Have documented major electrocardiogram (ECG) abnormalities which are clinically significant at the Investigator's discretion (for example, symptomatic or sustained atrial or ventricular arrhythmias, second- or third-degree atrioventricular block, bundle-branch blocks, ventricular hypertrophy, or recent myocardial infarction or a mean QTc of >470 ms [calculated using Fridericia's Correction, confirmed by triplicate ECG])
• Cardiac function: left ventricular ejection fraction (LVEF) assessed by ECHO or MUGA <45% (evaluation based on institutional lower limit of normal) and the patient has a significant cardiac history, or the investigator suspects ongoing cardiac pathology
• Have the presence of cardiac disease, including a myocardial infarction or any other arterial thrombotic event including cerebrovascular accident or transient ischemic attack within 6 months prior to enrollment, unstable angina pectoris, New York Heart Association (NYHA) Class III-IV congestive heart failure, aneurysm of major vessels or heart, uncontrolled hypertension.

Where it is running

• Colorado Blood Cancer Institute — Denver, Colorado, United States (enrolling)
• Willamette Valley Cancer Institute and Research Center — Eugene, Oregon, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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