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Pomalidomide, Ixazomib, and Dexamethasone With or Without Intensification by Cyclophosphamide in Relapsed or Refractory Multiple Myeloma

NCT03731832 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-09-30

No results posted yet for this study

Summary

The study is designed as a multicenter, non-randomized, Phase II trial with one treatment arm. A total of 82 patients of both genders and older than 18 years with relapsed/refractory multiple myeloma are planned to be included in the study. After the first 6 patients will have finished the first treatment cycle of the induction phase the DMC will assess safety and tolerability of the treatment schedule and decide about the further continuation of the study.

Conditions

  • Refractory Multiple Myeloma

Interventions

DRUG

MLN9708

Study drug will be given as a single, oral dose of 4.0 mg weekly (day 1, 8 and 15) for 3 weeks, followed by 1 week without study drug in a 28-day cycle

DRUG

Pomalidomide 4 MG Oral Capsule

Study drug will be given as an oral dose of 4.0 mg on day 1 until day 21, followed by 1 week without study drug in a 28-day cycle.

DRUG

Dexamethasone

Dexamethasone will be administered as a single, oral dose of 40 mg/day weekly on day 1, 8, 15 and 22 in patients from 18 to 74 years old. For patients ≥ 75 years old dose has to be reduced to 20 mg/day with the same treatment schedule.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered once daily as an oral dose of 50 mg on cycle days 1 to 21, followed by one week without drug in a 28-day cycle.

Sponsors & Collaborators

  • GWT-TUD GmbH

    lead OTHER

Principal Investigators

  • Stefan Knop, Prof. · Universitätsklinikum Würzburg / Medizinische Klinik und Poliklinik II

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-20
Primary Completion
2024-04-22
Completion
2024-04-22

Countries

  • Germany

Study Locations

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Entities

Drugs

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 NCT03731832 on ClinicalTrials.gov