A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma (MagnetisMM-30)

Официальное название

A PHASE 1B, OPEN-LABEL STUDY OF ELRANATAMAB IN COMBINATION WITH IBERDOMIDE IN PARTICIPANTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA

Обзор

The main purpose of the study is to understand how safe and tolerable is elranatamab when given along with iberdomide. There are 2 parts to this study. Part 1 will look at how safe and tolerable is elranatamab when given with iberdomide. Part 2 will look at the correct amount of this combination that can be given to patients with relapsed or refractory multiple myeloma. Myeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies). Refractory means a disease or condition that does not respond to treatment. Relapsed means the return of a disease after a period of improvement. All study medicines are given in cycles that last 28 days. Everyone taking part in this study will receive elranatamab as a shot under the skin. Iberdomide will be taken by mouth once a day for 21 days over a 28-day cycle. Participants will receive study medicine until: * their disease progresses or, * they experience unacceptable side effects or, * they choose to no longer take part in the study. The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and can be used for multiple myeloma treatment.

Вмешательства

• Препарат Elranatamab
  BCMA-CD3 bispecific antibody
• Препарат Iberdomide
  cereblon-modulating agent

Первичные конечные точки

• Part 1: Number of participants with dose limiting toxicity (DLT) [Срок оценки: Cycle 1, about 28 days]
• Part 2: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment [Срок оценки: Assessed from baseline up to 90 days after last dose of study treatment]

Вторичные конечные точки (12)

• Part 1: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment [Срок оценки: Assessed from baseline up to 90 days after last dose of study treatment]
• Part 1 and Part 2: Number of Participants with Adverse Events (AE) characterized by type, frequency, severity [Срок оценки: Assessed from baseline up to 90 days after last dose of study treatment]
• Part 1 and Part 2: Number of Participants with Clinically Significant Change from Baseline in Laboratory Abnormalities [Срок оценки: Assessed from baseline up to 90 days after last dose of study treatment]
• Part 1 and Part 2: Percentage of Participants with Objective Response Rate (ORR) [Срок оценки: Assessed for approximately 2 years]
• Part 1 and Part 2: Percentage of Participants with Complete Response Rate (CRR) [Срок оценки: Assessed for approximately 2 years]
• Part 1 and Part 2: Time to Response (TTR) [Срок оценки: Assessed for approximately 2 years]
• Part 1 and Part 2: Duration of Response (DOR) [Срок оценки: Assessed for approximately 2 years]
• Part 1 and Part 2: Duration of Complete Response (DOCR) [Срок оценки: Assessed for approximately 2 years]
• Part 1 and Part 2: Time of Progression Free Survival (PFS) [Срок оценки: Assessed for approximately 2 years]
• Part 1 and Part 2: Time of Overall Survival (OS) [Срок оценки: Assessed for approximately 2 years]
• Part 1 and Part 2: Minimal Residual Disease (MRD) Negativity Rate [Срок оценки: Assessed for approximately 2 years]
• Part 1 and Part 2: Concentrations of elranatamab [Срок оценки: Assessed for approximately 2 years]

Критерии участия

Критерии включения

• Prior diagnosis of multiple myeloma as defined by IMWG criteria
• Measurable disease based on IMWG criteria as defined by at least 1 of the following:
• Serum M-protein ≥0.5 g/dL by SPEP
• Urinary M-protein excretion ≥200 mg/24 hour by UPEP
• Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FL ratio (<0.26 or >1.65)
• Part 1: Received 2-4 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
• Part 2: Received 1-3 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
• ECOG performance status 0-1
• Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1

Критерии исключения

• Plasma cell leukemia, Smoldering multiple myeloma, Waldenström's macroglobulinemia, Amyloidosis, POEMS Syndrome
• Impaired cardiovascular function or clinically significant cardiovascular diseases
• Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease
• Participants with any active, uncontrolled bacterial, fungal, or viral infection
• Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
• Previous treatment with:
• BCMA-directed or CD3 redirecting therapy
• Iberdomide (CC-220) or Mezigdomide
• Administration of strong inhibitor or inducer of CYP3A4/5 within 2 weeks prior to dosing and during the study
• Administration with an investigational product within 30 days preceding the first dose of study intervention
• Participant is unable or unwilling to undergo protocol required thromboembolism prophylaxis

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 34 центра

• Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center — Coral Gables
• University of Miami Hospital and Clinics Deerfield Beach — Deerfield Beach
• Sylvester Comprehensive Cancer Center- Doral — Doral
• Sylvester Comprehensive Cancer Center — Miami
• University of Miami Hospital and Clinics — Miami
• Sylvester Comprehensive Cancer Center Kendall — Miami
• Sylvester Comprehensive Cancer Center Plantation — Plantation
• Emory University Hospital Midtown — Atlanta
• … и ещё 26 центров

Австралия · 6 центров

• Liverpool Hospital — Liverpool
• Calvary Mater Newcastle — Waratah
• Townsville University Hospital — Douglas
• Epworth Freemasons — East Melbourne
• Epworth Hospital — Richmond
• Slade Pharmacy — Richmond

Канада · 3 центра

• Dr. Everett Chalmers Regional Hospital — Fredericton
• CIUSSS de l'Est-de-l'Île-de-Montréal — Montreal
• Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospital — Sherbrooke

Идентификаторы

NCT: NCT06215118 · C1071030 · MagnetisMM-30

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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