Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (MM) (NCT02899052) — USA Trial Details

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

CarfilzomibVenetoclaxDexamethasone

Carfilzomib: Carfilzomib lyophilized administered intravenously as a 10 to 30 minute infusion in Cycles 1 and beyond within 30 minutes to 4 hours after dexamethasone dosing. Dose level 1 (K1) Cycle 1: 20 mg/m2 on Days 1 and 2, 27 mg/m2 on Days 8, 9, 15, and 16; Cycles 2 - 12: 27 mg/m2 on Days 1, 2, 8, 9, 15, and 16; Cycles 13 - 18: 27 mg/m2 on Days 1, 2, 15, and 16; Cycles 19 and beyond, for participants that have not previously transitioned to monotherapy: 27 mg/m2 on Days 1, 2, 15, and 16. Dose Level K2: Cycle 1: 20 mg/m2 on Day 1; 70 mg/m2 on Days 8 and 15 Cycles 2 - onward: 70 mg/m2 on Days 1, 8, and 15. Dose Level K3: Cycle 1: 20 mg/m2 on Days 1 and 2; 56 mg/m2 on Days 8, 9, 15, and 16. Cycles 2 - onward: 56 mg/m2 on Days 1, 2, 8, 9, 15, and 16.

Venetoclax: Venetoclax tablet administered orally once daily during Cycles 1 - onward. Venetoclax dose level 1 (Ven1) 400 mg once daily, Ven2 800 mg once daily.

Dexamethasone: Dexamethasone tablet administered orally during Cycles 1 - onward. Dexamethasone dose level 1 (Dex1) 40 mg once weekly, Dex2 40 mg once weekly, Dex3 20 mg twice weekly.

Study summary

A Phase 2, open-label, dose escalation study to evaluate the safety and efficacy of venetoclax in combination with carfilzomib-dexamethasone (Kd) in participants with relapsed or refractory MM and have received 1 to 3 prior lines of therapy.

Part 4 of this study is currently enrolling.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

No

Inclusion Criteria: * Eastern Collaborative Oncology Group (ECOG) performance score of less than or equal to 2. * Documented relapsed or progressive Multiple Myeloma (MM) on or after any regimen or is refractory to the most recent line of therapy. * Positive for translocation t(11;14) as determined by an analytically validated Fluorescent In Situ Hybridization (FISH) assay per central laboratory testing. * Received prior treatment with at least 1 prior line of therapy for MM. * Measurable disease on Screening per International Myeloma Working Group (IMWG) criteria. * Meets absolute neutrophil count, platelet count, hemoglobin, liver and kidney function laboratory values within 2 weeks prior to first dose of study drug. Exclusion Criteria: * Has a pre-existing condition that is contraindicated including. * Non-secretory or oligo-secretory MM * Active plasma cell leukemia. * Waldenström's macroglobulinemia. * Primary amyloidosis. * POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes). * Active hepatitis B or C infection based on screening blood testing. * Known active Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. * Significant cardiovascular disease. * Major surgery within 4 weeks prior to first dose. * Acute infections requiring antibiotic, antifungal or antiviral therapy within14 days prior to first dose. * Peripheral neuropathy ≥ Grade 3 or ≥ Grade 2 with pain within 2 weeks prior to first dose. * Uncontrolled diabetes or uncontrolled hypertension within 14 days prior to first dose. * Any other medical condition that, in the opinion of the Investigator, would adversely affect the participant's participation in the study. * History of other active malignancies, including myelodysplastic syndrome (MDS), within the past 3 years prior to study entry Other protocol defined inclusion/exclusion criteria could apply

Primary outcome measure(s)

Number of Participants with Adverse Events — First dose of study drug through at least 30 days after end of treatment (approximately 2 years)
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Very Good Partial Response (VGPR) or Better Response Rate of VenKd in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) as well as Those with t(11;14)-positive RRMM — First dose of study drug through at least 30 days after end of treatment (approximately 2 years)
VGPR or better response rate is defined as the percentage of participants with documented VGPR or better based on IMWG criteria.
Objective Response Rate (ORR) of VenKd in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) as well as Those with t(11;14)-positive RRMM — First dose of study drug through at least 30 days after end of treatment (approximately 2 years)
ORR is defined as the percentage of participants with a documented PR or better based on IMWG criteria.
Complete Response (CR) or Better Rate of VenKd in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) as well as Those with t(11;14)-positive RRMM — First dose of study drug through at least 30 days after end of treatment (approximately 2 years)
Complete response or better rate is defined as the percentage of participants with documented CR or better based on IMWG criteria.

Trial sites (32)

Facility	City	Region
University of Alabama at Birmingham - Main /ID# 151405	Birmingham	Alabama
University of Arkansas for Medical Sciences /ID# 151399	Little Rock	Arkansas
Memorial Healthcare System /ID# 224862	Hollywood	Florida
Winship Cancer Institute of Emory University /ID# 161710	Atlanta	Georgia
The University of Chicago Medical Center /ID# 151395	Chicago	Illinois
Indiana Blood & Marrow Transpl /ID# 218862	Indianapolis	Indiana
Duplicate_University of Kentucky Chandler Medical Center /ID# 151407	Lexington	Kentucky
Central Maine Medical Center /ID# 218856	Lewiston	Maine
Duplicate_University of Maryland School of Medicine /ID# 159721	Baltimore	Maryland
Oncology Hematology Associates (OHA) - Springfield /ID# 218855	Springfield	Missouri
Washington University-School of Medicine /ID# 222651	St Louis	Missouri
Duke Cancer Center /ID# 162062	Durham	North Carolina
University of Pennsylvania /ID# 151768	Philadelphia	Pennsylvania
University of Texas Southwestern Medical Center /ID# 218336	Dallas	Texas
Baylor Scott & White Medical Center- Temple /ID# 218252	Temple	Texas
University of Utah /ID# 151397	Salt Lake City	Utah
Duplicate_VA Puget Sound Healthcare Syst /ID# 155369	Seattle	Washington
Aurora Health Care, Aurora Cancer Center /ID# 209612	Wauwatosa	Wisconsin
Border Medical Oncology Research Unit Albury Wodonga Regiona /ID# 222200	East Albury	New South Wales
Calvary Mater Newcastle /ID# 218739	Waratah	New South Wales
Flinders Medical Centre /ID# 221345	Bedford Park	South Australia
Royal Hobart Hospital /ID# 217546	Hobart	Tasmania
Debreceni Egyetem-Klinikai Kozpont /ID# 217624	Debrecen	Hajdú-Bihar
Semmelweis Egyetem /ID# 217626	Budapest	Hungary
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 217625	Budapest	Hungary
Szegedi Tudományegyetem /ID# 219172	Szeged	Hungary
Auxilio Mutuo Cancer Center /ID# 157853	San Juan	Puerto Rico
VA Caribbean Healthcare System /ID# 157854	San Juan	Puerto Rico
Hospital Universitario Germans Trias i Pujol /ID# 218006	Badalona	Barcelona
Hospital Clinic de Barcelona /ID# 218007	Barcelona	Spain
Hospital General Universitario Gregorio Maranon /ID# 218005	Madrid	Spain
Hospital Universitario Ramon y Cajal /ID# 220925	Madrid	Spain

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