Sign Up Now!
To sign up for our newsletter or print publications, please enter your contact information below.
First Name *
Last Name *
Email Address (Verify) *
We will request your mailing address on the next page.
We will request your mailing address on the next page.

COMPLETED RESEARCH: CLINICAL/TRANSLATIONAL RESEARCH
Abstract #CT08

In-Class Transition from Parenteral Bortezomib to Oral Ixazomib in Newly Diagnosed Multiple Myeloma: Updated Real-World Results from the Community-Based US MM-6 Study

JHOP - March 2021 Vol 11 Special Feature - HOPA Abstracts, Clinical Trials, Multiple Myeloma

Presenter: Joshua Richter, MD, Assistant Professor of Medicine, Icahn School of Medicine at Mount Sinai

Co-Authors: Habte A. Yimer, Texas Oncology/US Oncology Research, Tyler, TX; Stephen J. Noga, Millennium Pharmaceuticals, Cambridge, MA, a wholly owned subsidiary of Takeda; Sudhir Manda, Arizona Oncology/US Oncology Research, Tucson, AZ; Roger M. Lyons, Texas Oncology/US Oncology Research, San Antonio, TX; Kimberly Bogard, Millennium Pharmaceuticals, Cambridge, MA, a wholly owned subsidiary of Takeda; Presley Whidden, Millennium Pharmaceuticals, Cambridge, MA, a wholly owned subsidiary of Takeda; Dasha Cherepanov, Millennium Pharmaceuticals, Cambridge, MA, a wholly owned subsidiary of Takeda; Jack Aiello, Patient Empowerment Network, San Jose, CA; Saulius Girnius, Trihealth Cancer Institute, Cincinnati, OH; Robert M. Rifkin, Rocky Mountain Cancer Centers/US Oncology Research, Denver, CO

Background: Long-term proteasome inhibitor (PI)-based treatment is associated with improved outcomes in multiple myeloma. However, prolonged therapy with parenteral PIs can be challenging. The US MM-6 study (NCT03173092) is investigating in-class transition from parenteral bortezomib-based induction to all-oral ixazomib-lenalidomide-dexamethasone (IRd) in US community patients, with the aim of increasing PI-based treatment duration, while maintaining quality of life and improving outcomes.

Objectives: The primary end point is progression-free survival (PFS); key secondary end points include rate of partial response, very good partial response (VGPR), and complete response (CR) rates, as well as duration of therapy.

Methods: Transplant-ineligible patients or patients with delayed (>24 months) newly diagnosed multiple myeloma and stable disease or better after 3 cycles of bortezomib-based induction are being enrolled to undergo in-class transition and receive IRd (up to 39 28-day cycles or until disease progression or unacceptable toxicity).

Results: At data cutoff, 101 patients had received treatment. The patients’ median age is 73 years; 46% are aged ≥75 years; 16% are black/African American; 10% are Hispanic/Latino; 26% have calculated creatinine clearance <60 mL/min. At the start of IRd therapy, 95% of patients had ≥1 comorbidities, including renal and urinary disorders (38%), cardiac disorders (29%), and peripheral neuropathy (14%). With 52% of the patients continuing therapy and the enrollment is ongoing, the mean duration of therapy from the start of bortezomib-based induction was 12.4 months; mean IRd duration of therapy after in-class transition was 9.2 months. Patients have received IRd for up to 29.4 months to date. The overall response rate (ORR) after bortezomib-based induction was 62% (7% CR, 32% ≥VGPR). After in-class transition, the ORR increased to 71%, and the CR and ≥VGPR rates increased to 29% and 53%, respectively. The 12-month PFS rate was 84% from the start of bortezomib-based induction and 80% from the start of IRd. During IRd treatment to date, 91% of patients have had treatment-emergent adverse events (AEs; 53% grade ≥3). Treatment-emergent AEs led to study-drug modification and discontinuation in 52% and 7% of patients, respectively. Serious treatment-emergent AEs occurred in 37% of the patients. Diarrhea, peripheral neuropathy, nausea, and vomiting occurred in 43% (8% grade 3), 32% (2%), 23% (2%), and 14% (2%) of patients, respectively. Other (≥5%) grade 3 treatment-emergent AEs were pneumonia (7%) and syncope (5%).

Conclusion: Patients in the US MM-6 study reflect the real-world US population with multiple myeloma, including mostly elderly, comorbid, community-based patients with newly diagnosed multiple myeloma. In-class transition to IRd after 3 cycles of bortezomib-based induction resulted in improved response rates and depths of responses, as well as prolonged duration of therapy, and may thereby improve outcomes for real-world patients. In-class transition to an all-oral regimen could also prevent treatment interruptions for patients who are unable to, or prefer not to, travel regularly to a clinic for treatment.

Related Items
New CAR T-Cell Therapy Produces Durable Responses in Relapsed or Refractory Multiple Myeloma
Wayne Kuznar
Web Exclusives published on October 11, 2021 in Multiple Myeloma, ASCO Highlights
FDA Approved Pepaxto for Relapsed or Refractory Multiple Myeloma
JHOP - April 2021 Vol 11, No 2 published on April 27, 2021 in FDA Updates, Multiple Myeloma
Abecma First CAR T-Cell Therapy Approved for Multiple Myeloma
JHOP - April 2021 Vol 11, No 2 published on April 27, 2021 in FDA Updates, Multiple Myeloma
Safety and Antitumor Activity of Dostarlimab in Patients with Advanced or Recurrent DNA Mismatch Repair-Deficient or -Proficient Endometrial Cancer: Results from the GARNET Study
JHOP - March 2021 Vol 11 Special Feature published on April 9, 2021 in HOPA Abstracts, Biomarkers, Clinical Trials, Gynecologic Cancers
Operation Angel on the Line: Oncology Pharmacist and Pharmacy Students Piloting a New Oral Chemotherapy Telehealth Clinic During the COVID-19 Pandemic
JHOP - March 2021 Vol 11 Special Feature published on April 9, 2021 in HOPA Abstracts, Chemotherapy, COVID-19
Integration of a Clinical Pharmacist in a Phase 1 Clinical Trial Program
JHOP - March 2021 Vol 11 Special Feature published on April 9, 2021 in HOPA Abstracts, Clinical Trials
Feasibility and Perceived Benefit of an Oral Chemotherapy Pharmacy Monitoring Program to Assess Symptom Burden and Medication Adherence in Patients with Cancer
JHOP - March 2021 Vol 11 Special Feature published on April 9, 2021 in HOPA Abstracts, Chemotherapy, Oncology Pharmacy Protocols
The Incidence of Coring Between the Traditional Syringe and Needle Compounding Technique and Closed-System Transfer Devices
JHOP - March 2021 Vol 11 Special Feature published on April 9, 2021 in HOPA Abstracts, Infusion Issues
Safety of Switching e-Prescribing Platform Body Surface Area Calculation from DuBois & DuBois to Mosteller on Active Chemotherapy Doses
JHOP - March 2021 Vol 11 Special Feature published on April 9, 2021 in HOPA Abstracts, Chemotherapy
Impact of Drug Repository Program in a Rural Oncology Clinic
JHOP - March 2021 Vol 11 Special Feature published on April 9, 2021 in HOPA Abstracts, Adverse Events, Oncology Pharmacy Programs
Copyright © Green Hill Healthcare Communications, LLC. All rights reserved.