Pembrolizumab, Belantamab and Dexamethasone in Refractory Multiple Myeloma.

NCT05493618 | Withdrawn Phase 1 DMC FDA Drug

• 2 other identifiers: Pro2022-0093ISS 60989
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Multiple Myeloma, Refractory

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  To evaluate the overall response rate for pembrolizumab, belantamab and dexamethasone (PBd) in patients with triple class refractory multiple myeloma.

  2 years

Secondary Outcomes (4)

• Progression-Free Survival (PFS)

  2 years

• Overall Survival (OS)

  2 years

• Time to next treatment

  2 years

• Tolerability and Safety

  2 years

Study Arms (1)

Single-arm, multi-institution

EXPERIMENTAL

Study Arm: Pembrolizumab 200 mg IV q3 weeks Belantamab 2.5 mg/kg IV q3 weeks. Dex 40 mg IV q3 weeks (20 mg if patient \>75) Treatment will be administered on a 21-day cycle and will be continued until unacceptable toxicity or disease progression for up to 2 years (35 cycles)

Drug: Pembrolizumab; Drug: Belantamab mafodotin; Drug: Dexamethasone

Interventions

Pembrolizumab DRUG

Pembrolizumab 200 mg IV q3 weeks until unacceptable toxicity or disease progression for up to 2 years (35 cycles).

Also known as: Keytruda

Single-arm, multi-institution

Belantamab mafodotin DRUG

Belantamab 2.5 mg/kg IV q3 weeks until unacceptable toxicity or disease progression for up to 2 years (35 cycles).

Also known as: Blenrep

Single-arm, multi-institution

Dexamethasone DRUG

Dexamethasone 40 mg IV q3 weeks (20 mg if patient \>75) until unacceptable toxicity or disease progression for up to 2 years (35 cycles).

Also known as: Decadron

Single-arm, multi-institution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients must have relapsed or must be considered refractory to all of the following:
• a proteasome inhibitor,
• an immunomodulating agent,
• a CD38-monoclonal antibody
• an autologous stem cell transplant
• CAR T-cell therapy (or ineligible)
• Patients must have more than 4 lines of prior therapy.
• Measurable disease, defined as one of the following:
• M-protein ≥ 0.5g/dL (0.3 g/dL or above if IgA subtype)
• Urine M-protein ≥ 200 mg/24hours
• Serum free light chain difference \> 100 mg/L
• Biopsy proven plasmacytoma
• Bone marrow involvement \>10%
• Life expectancy \>3 months

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

Sponsors & Collaborators

• Hackensack Meridian Health: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (3)

Lombardi Comprehensive Cancer Center, Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

John Theurer Cancer Center, Hackensack Meridian Health

Hackensack, New Jersey, 07410, United States

Location

Jersey Shore Medical Center

Neptune City, New Jersey, 07753, United States

Location

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MeSH Terms

Conditions

Multiple Myeloma

Interventions

pembrolizumab; belantamab mafodotin; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Noa Biran, MD

  Division of Hematology and Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 9, 2022
• Study Start: December 1, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)