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Ixazomib-pomalidomide-dexamethasone as Second or Third-line Combination Treatment for Patients With Relapsed and Refractory Multiple Myeloma Previously Treated With Daratumumab, Lenalidomide and Bortezomib

NCT04790474 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-07-24

No results posted yet for this study

Summary

Adult patients with a confirmed diagnosis of symptomatic and relapsed and/or refractory MM, after receiving bortezomib, lenalidomide and daratumumab during first and second lines, will be eligible to be enrolled in this study.

During the first three treatment cycles, patients will be seen twice (Days 1 and 15 of the cycle). Starting from cycle 4 and on, patients will be assessed once per cycle (Day 1), until disease progression, for disease response and progression according to the International Myeloma Working Group (IMWG) criteria. After progression, all patients will be followed for survival; for this purpose, patients will be contacted every 12 weeks until death or termination of the study by the Sponsor.

Patients may continue to receive treatment for 24 months or until disease progression (PD) or unacceptable toxicity, the earlier of the three. Dose modifications may be made based on toxicities. Patients who complete study therapy will continue to receive treatment per standard of care.

Conditions

  • Multiple Myeloma in Relapse
  • Refractory Multiple Myeloma

Interventions

DRUG

ixazomib-pomalidomide-dexamethasone

Cycles 1-3: during each 21-day cycle: * ixazomib 3 mg on Days 1, 4, 8 and 11 * pomalidomide 4 mg on Days 1 through 14 * dexamethasone 20 mg on Days 1, 2, 8, 9, 15, 16 Cycle 4 and consequently: during each 28-day cycle: * ixazomib 4 mg on Days 1, 8 and 15 * pomalidomide 4 mg on Days 1 through 21 * dexamethasone 20 mg on Days 1, 2, 8, 9, 15, 16, 22 and 23

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Yael Cohen, MD · Tel-Aviv Sourasky Medical Center

  • Noa Lavi, MD · Rambam Health Care Campus

  • Moshe Gat, MD · Hadassah Ein-Keerm Medical Center

  • Iuliana Vaxman, MD · Rabin Medical Center

  • Hila Magen, MD · Shiba Tel Hashomer Medical Center

  • Chezi Ganzel, MD · Shearei Zedek Medical Center

  • Evgeni Chubar, MD · Emek Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-25
Primary Completion
2026-03-01
Completion
2029-09-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04790474 on ClinicalTrials.gov