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Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma
- Source :
- Blood advances. 3(4)
- Publication Year :
- 2018
-
Abstract
- The addition of clarithromycin enhances the efficacy of lenalidomide plus dexamethasone in treatment-naive multiple myeloma (MM). We conducted a phase 2 trial to evaluate the safety and efficacy of clarithromycin, pomalidomide, and dexamethasone (ClaPd) in relapsed or refractory multiple myeloma (RRMM) with prior lenalidomide exposure. One hundred twenty patients with a median of 5 prior lines of therapy received clarithromycin 500 mg orally twice daily, pomalidomide 4 mg orally on days 1 to 21, and dexamethasone 40 mg orally on days 1, 8, 15, and 22 of a 28-day cycle. The overall response rate (ORR) was 60% with 23% achieving at least a very good partial response. There was no statistical difference in response rates for patients who were refractory to lenalidomide (ORR, 58%), bortezomib (ORR, 55%), or both lenalidomide and bortezomib (ORR, 54%). Median progression-free survival (PFS) for the cohort was 7.7 months and median overall survival (OS) was 19.2 months. A history of dual-refractoriness to lenalidomide and bortezomib did not significantly impact either PFS or OS. The most common toxicities were neutropenia (83%), lymphopenia (74%), and thrombocytopenia (71%). The most common grade ≥3 toxicities included neutropenia (58%), thrombocytopenia (31%), and anemia (28%). ClaPd is an effective combination in RRMM with response and survival outcomes that are independent of lenalidomide- or bortezomib-refractory status. Toxicities are manageable with low rates of nonhematologic or high-grade events. ClaPd is a convenient, all-oral option in RRMM with comparable efficacy to other highly active, 3-drug, pomalidomide-based combinations. This trial was registered at www.clinicaltrials.gov as #NCT01159574.
- Subjects :
- Adult
Male
medicine.medical_specialty
Clinical Trials and Observations
Phases of clinical research
Neutropenia
Gastroenterology
Dexamethasone
Clarithromycin
Internal medicine
hemic and lymphatic diseases
Antineoplastic Combined Chemotherapy Protocols
Medicine
Humans
Multiple myeloma
Lenalidomide
Aged
Aged, 80 and over
business.industry
Bortezomib
Hematology
Middle Aged
medicine.disease
Pomalidomide
Survival Analysis
Thalidomide
Treatment Outcome
Female
Neoplasm Recurrence, Local
business
Multiple Myeloma
medicine.drug
Subjects
Details
- ISSN :
- 24739537
- Volume :
- 3
- Issue :
- 4
- Database :
- OpenAIRE
- Journal :
- Blood advances
- Accession number :
- edsair.doi.dedup.....80918c3932b453fd86e8a5a717a8057a