Study of Dara-Pembro for Multiple Myeloma Patients

NCT04361851 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: LCI-HEM-DRMM-DPEM-00100043318
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase II, single-arm, open-label study in subjects with relapsed and/or refractory multiple myeloma (RRMM) comparing Pembrolizumab (Pembro) in combination with Daratumumab (Dara) to the historical control of Daratumumab.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 8-Month Progression-Free Survival (PFS8)

  PFS8 will be determined for each subject as a binary variable indicating whether or not the subject is alive and progression free at 8 months.

  8 months

Secondary Outcomes (9)

• Complete Response (CR) Rate

  up to 5 years

• Stringent Complete Response (sCR) Rate

  up to 5 years

• Clinical Benefit Rate (CBR)

  up to 5 years

• Overall Response Rate (ORR)

  up to 5 years

• Time to First Response (TTFR)

  up to 5 years

Study Arms (1)

Single Arm

EXPERIMENTAL

Pembrolizumab and Daratumumab

Drug: Pembrolizumab

Interventions

Pembrolizumab DRUG

Experimental

Also known as: KEYTRUDA

Single Arm

Eligibility Criteria

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

You may not qualify if:

• Written informed consent and HIPAA authorization for release of personal health information.
• Age ≥ 18 years at the time of consent.
• ECOG Performance Status of ≤ 1.
• Documented symptomatic/active multiple myeloma with measurable disease that has previously responded to therapy (partial response or better by IMWG criteria) and since relapsed or is refractory to the last line of therapy. Refractory disease is defined as evidence of progressive disease per IMWG criteria within 60 days (measured from the end of the last cycle) after completing treatment with the last anti-myeloma drug regimen.
• Note: measurable disease is defined as
• Serum monoclonal protein level ≥ 0.5 g/dL for IgG, IgA, or IgM disease
• Monoclonal protein or total serum IgD ≥ 0.5 g/dL for IgD disease
• Urinary M-protein excretion of ≥ 200 mg over a 24-hour period
• Involved free light chain level ≥ 10 mg/dL, along with an abnormal free light chain ratio
• Subjects must have a documented history of relapsed and/or refractory multiple myeloma with 3 or more prior lines of therapy.
• Subjects must have had prior exposure to daratumumab in one of the prior lines of therapy.
• Prior cancer treatment, including chemotherapy and radiation therapy, must be completed at least 14 days prior to enrollment and the subject must have recovered from all reversible acute toxic effects of the regimen to their previous baseline or \≤ Grade 1. Exceptions include alopecia (all grades) and neuropathy (grade 1 with controlled pain, grade 2 without pain).
• Demonstrate adequate organ function as defined below; all screening labs to be obtained within 3 days prior to initiating study treatment:
• Absolute neutrophil count (ANC) ≥ 1.0 x 109/L
• Platelets ≥ 75 x 109/L

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

Multiple Myeloma

Interventions

pembrolizumab

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

Study Officials

• Saad Usmani, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: June 9, 2021
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 26, 2022

Record last verified: 2022-01