Pembrolizumab, Belantamab and Dexamethasone in Refractory Multiple Myeloma.

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Multiple Myeloma, Refractory

In brief

This is a single arm, multi-institution (1) Hackensack Meridian Health at Hackensack, New Jersey (NJ) (2) Jersey Shore Medical Center, Neptune, NJ and (3) Georgetown/Lombardi Cancer Center) phase II study of the combination of pembrolizumab, belantamab, and dexamethasone in patients with triple class refractory multiple myeloma.

Key facts

Study ID: NCT05493618
Run by: Hackensack Meridian Health
People needed: 0
Starts: 2022-12-01
Expected to finish: 2025-11-01
Last updated by the study team: 2023-01-27

Who can join

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

You may not qualify if…

Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
Any of the following laboratory abnormalities (unless there is >50% plasma cell involvement of the bone marrow):
Absolute neutrophil count (ANC) < 1,000/μL
Platelet count < 30,000/μL
Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L)
Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) ≥ 2.5 x upper limit of normal (ULN)
Serum total bilirubin, direct bilirubin, and alkaline phosphatase ≥ 1.5 x ULNf. Subjects with serious renal impairment ([CrCl] < 50 mL/min) or requiring dialysis would be excluded
g. International Normalized Ratio (INR) of >1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Subjects with a prior history of malignancies, other than Multiple Myeloma (MM), unless the subject has been free of the disease for ≥ 5 years with the exception of the following noninvasive malignancies:
Basal cell carcinoma of the skin
Squamous cell carcinoma of the skin
Carcinoma in situ of the cervix
Carcinoma in situ of the breast
Incidental histological findings of prostate cancer such as T1a or T1b using the Tumor/Node/Metastasis (TNM) classification of malignant tumors or prostate cancer that is curative
Subject has received a prior anti-BCMA therapy
Subject has received prior systemic anti-cancer therapy including investigational agents within 3 weeks prior to study intervention
Subject has received prior radiotherapy within 2 weeks of start of study intervention.
Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease
Subject has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 3 weeks prior to the first dose of study intervention
Subject has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
Subject has known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis.
Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 3 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
Subject has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Subject has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.

Where it is running

Lombardi Comprehensive Cancer Center, Georgetown University — Washington D.C., District of Columbia, United States
John Theurer Cancer Center, Hackensack Meridian Health — Hackensack, New Jersey, United States
Jersey Shore Medical Center — Neptune City, New Jersey, United States

Full record on ClinicalTrials.gov

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