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Ph 2 Maintenance Trial: Ixazomib vs Ixazomib-Lenalidomide for MM Patients

NCT03733691 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-10-25

No results posted yet for this study

Summary

This is a randomized, Phase 2 study involving two arms evaluating the efficacy and safety of ixazomib alone and the combination of both ixazomib and lenalidomide as maintenance therapy for patients with multiple myeloma who have achieved at least partial response (PR) or better after receiving a bortezomib- and lenalidomide-containing combination front-line therapy.

Conditions

  • Newly Diagnosed Multiple Myeloma

Interventions

DRUG

Ixazomib

3 mg oral capsule, Days 1, 8 and 15 of 28-day cycles

DRUG

Lenalidomide

Same dose as in the front-line treatment in the last treatment cycle, taken orally, on days 1-28 of a 28-day cycle.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Oncotherapeutics

    lead INDUSTRY

Principal Investigators

  • James R. Berenson M Inc., MD · Oncotherapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2023-10-19
Completion
2023-10-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT03733691 on ClinicalTrials.gov