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Venetoclax, Ixazomib Citrate, and Dexamethasone in Treating Patients with Relapsed Multiple Myeloma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Venetoclax, Ixazomib Citrate, and Dexamethasone in Treating Patients with Relapsed Multiple Myeloma

Phase I Clinical Trial of Venetoclax (ABT-199) in Combination with Ixazomib and Dexamethasone for Patients with Relapsed Multiple Myeloma

NCT03399539•Mayo Clinic

View on ClinicalTrials.gov

Summary

This phase I trial studies the side effects and best dose of venetoclax when given together with ixazomib citrate and dexamethasone and to see how well they work in treating patients with multiple myeloma that has come back. Venetoclax and ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with ixazomib citrate and dexamethasone may work better in treating patients with multiple myeloma.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of venetoclax in combination with ixazomib citrate (ixazomib) and dexamethasone in patients with relapsed multiple myeloma (MM). (Phase 1) SECONDARY OBJECTIVES: I. To describe toxicities associated with venetoclax, in combination with ixazomib and dexamethasone in patients with relapsed MM. (Phase 1) TERTIARY OBJECTIVES: I. To explore levels of BCL-2 family member proteins (BCL-2, BCL-x, MCL-1) on bone marrow biopsies using ribonucleic acid sequencing (RNASeq) and immunohistochemistry. OUTLINE: This is a phase I, dose-escalation study of venetoclax followed by a phase II study. Patients receive venetoclax orally (PO) daily on days 1-28, ixazomib citrate PO once weekly on days 1, 8, and 15, and dexamethasone PO on days 1, 8, 15, and 22 for courses 1-12. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 or 6 months for 3 years.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Phase 1: Relapsed MM with at least one prior line of therapy and should have received a proteasome inhibitor and an immunomodulatory drug
•Phase 2: 1-3 prior lines of therapy and should have received a proteasome inhibitor and an immunomodulatory drug
•Obtained =\< 14 days prior to registration: Calculated creatinine clearance (using Cockcroft-Gault equation) \>= 30 mL/min
•Obtained =\< 14 days prior to registration: Absolute neutrophil count (ANC) \>= 1000/uL (without growth factor support)
•Obtained =\< 14 days prior to registration: Un-transfused platelet count \>= 75000/uL (\>= 50,000/uL if marrow plasma cells \[PC\]% \> 50%)
•Obtained =\< 14 days prior to registration: Hemoglobin \>= 8.0 g/dL
•Obtained =\< 14 days prior to registration: Total bilirubin =\< 1.5 x upper limit of normal (ULN)
•Obtained =\< 14 days prior to registration: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN
•Obtained =\< 14 days prior to registration: Alkaline phosphatase =\< 750 U/L
•Expansion cohort only: Plasma cell fluorescence in situ hybridization (FISH) test demonstrating presence of t(11;14)
+17 more criteria

Exclusion Criteria

•Diagnosed or treated for another malignancy =\< 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease; NOTE: Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection
•Any of the following:
•* Pregnant women
•* Nursing women
•* Men or women of childbearing potential who are unwilling to employ adequate contraception
•Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease
•Other concurrent chemotherapy or any ancillary therapy considered investigational
•* NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
•Peripheral neuropathy \>= grade 2 on clinical examination or grade 1 with pain during the screening period
•Major surgery =\< 14 days prior to study registration
+11 more criteria

Locations (3)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Siteman Cancer Center at Washington University

St Louis, Missouri, United States

Key Dates

Start Date

May 2, 2018

Primary Completion Date

December 20, 2021

Completion Date

February 23, 2024

Last Updated

November 4, 2024

Enrollment

ACTUAL participants

Conditions

Recurrent Plasma Cell MyelomaT(11;14)

Interventions

Dexamethasone

DRUG

Ixazomib Citrate

DRUG

Laboratory Biomarker Analysis

OTHER

Venetoclax

DRUG

Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple Myeloma

NCT05312255

Plasma Cell MyelomaRecurrent Plasma Cell Myeloma+2 more

View study

RECRUITINGPHASE2

Leflunomide, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma

NCT04508790

Recurrent Plasma Cell MyelomaRefractory Plasma Cell Myeloma

View study

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: November 4, 2024Data 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

Venetoclax, Ixazomib Citrate, and Dexamethasone in Treating Patients with Relapsed Multiple Myeloma

Inclusion Criteria

Exclusion Criteria

Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple Myeloma

Leflunomide, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma

Low-Dose Selinexor and Choline Salicylate for Non-Hodgkin or Hodgkin Lymphoma, Histiocytic/Dendritic Cell Neoplasm, or Relapsed or Refractory Multiple Myeloma

Immunomodulatory Drugs (Lenalidomide With or Without Pomalidomide) in Combination With a Corticosteroid Drug (Dexamethasone) for the Treatment of Multiple Myeloma

Ixazomib and Dexamethasone Versus Ixazomib, Dexamethasone and Lenalidomide, Randomized With NFKB2 Rearrangement

Pembrolizumab for the Treatment of Relapsed or Refractory Multiple Myeloma After Anti-BCMA CAR-T Therapies