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Pembrolizumab, Belantamab and Dexamethasone in Refractory Multiple Myeloma. | Clinical Trials | Clareo Health

WITHDRAWNPHASE1/PHASE2

Pembrolizumab, Belantamab and Dexamethasone in Refractory Multiple Myeloma.

A Phase II Study of Pembrolizumab, Belantamab and Dexamethasone in Patients With Triple Class Refractory Multiple Myeloma.

NCT05493618•Hackensack Meridian Health

View on ClinicalTrials.gov

Summary

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.

Detailed Description

This is a single arm, multi-institution (1) Hackensack Meridian Health at Hackensack, 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. All institutions will share the same Institutional Review Board. Safety lead-in Cohort: After the first 10 patients are enrolled, an independent safety review committee will meet to review adverse events and toxicity and determine whether the trial will continue to enroll. Phase 2 portion: The remainder of patients will be enrolled using a Simon's - 2 stage design. The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of multiple myeloma.
•2. Patients must have relapsed or must be considered refractory to all of the following:
•1. a proteasome inhibitor,
•2. an immunomodulating agent,
•3. a CD38-monoclonal antibody
•4. an autologous stem cell transplant
•5. CAR T-cell therapy (or ineligible)
•3. Patients must have more than 4 lines of prior therapy.
•4. Measurable disease, defined as one of the following:
•1. M-protein ≥ 0.5g/dL (0.3 g/dL or above if IgA subtype)
+14 more criteria

Exclusion Criteria

•1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
•2. Any of the following laboratory abnormalities (unless there is \>50% plasma cell involvement of the bone marrow):
•1. Absolute neutrophil count (ANC) \< 1,000/μL
•2. Platelet count \< 30,000/μL
•3. Corrected serum calcium \> 13.5 mg/dL (\> 3.4 mmol/L)
•4. 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)
•5. 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
•3. 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:
•1. Basal cell carcinoma of the skin
+27 more criteria

Locations (3)

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

Key Dates

Start Date

December 1, 2022

Primary Completion Date

November 1, 2025

Completion Date

November 1, 2025

Last Updated

January 27, 2023

Conditions

Multiple Myeloma, Refractory

Interventions

Pembrolizumab

DRUG

Belantamab mafodotin

DRUG

Dexamethasone

DRUG

HCMT/MM2401: Ph2 Study of Selinexor + Bispecific Antibody for RRMM

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RECRUITINGPHASE1

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Multiple Myeloma in RelapseMultiple Myeloma, Refractory

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pembrolizumab, Belantamab and Dexamethasone in Refractory Multiple Myeloma.

Inclusion Criteria

Exclusion Criteria

HCMT/MM2401: Ph2 Study of Selinexor + Bispecific Antibody for RRMM

A Trial of Selinexor, Ruxolitinib and Methylprednisolone

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