← Back to Search

Proteasome Inhibitor

Daratumumab + Bortezomib/Dexamethasone & Ixazomib for Multiple Myeloma

Phase 2

Waitlist Available

Led By Hans C Lee

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must have achieved a partial response or better to at least one prior line of therapy

Subjects must have histologically confirmed diagnosis of multiple myeloma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of first dose of any study drug treatment to the date of first documentation of progressive disease, or death due to any cause, whichever occurs first, assessed up to 18 months

Awards & highlights

Study Summary

This trial is testing a new immunotherapy treatment for patients with multiple myeloma that has come back or does not respond to treatment. The treatment consists of two drugs given with dexamethasone, a chemotherapy drug. The trial will test how well the treatment works.

Who is the study for?

This trial is for patients with multiple myeloma that has returned or hasn't responded to treatment. Participants must have had 1-3 prior treatments and shown some response, be in fair health (ECOG 0-2), agree to use contraception, and have measurable disease. They can't join if they've had certain drugs like ixazomib before, are allergic to study drugs, plan on having a stem cell transplant soon, or have other serious medical conditions.Check my eligibility

What is being tested?

The trial tests daratumumab with bortezomib and dexamethasone followed by daratumumab with ixazomib and dexamethasone in relapsed/refractory multiple myeloma patients. It examines whether this combination helps control the cancer better than previous treatments.See study design

What are the potential side effects?

Possible side effects include immune system reactions, infusion-related reactions from monoclonal antibodies like daratumumab, chemotherapy effects such as fatigue and digestive issues from dexamethasone, and nerve damage or blood disorders from bortezomib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My condition improved after previous cancer treatment.

Select...

I have been diagnosed with multiple myeloma through a biopsy.

Select...

I am able to care for myself and perform daily activities.

Select...

My condition worsened after the last treatment.

Select...

I am following the required contraceptive measures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of first dose of any study drug treatment to the date of first documentation of progressive disease, or death due to any cause, whichever occurs first, assessed up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of first dose of any study drug treatment to the date of first documentation of progressive disease, or death due to any cause, whichever occurs first, assessed up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of first dose of any study drug treatment to the date of first documentation of progressive disease, or death due to any cause, whichever occurs first, assessed up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression free survival (PFS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (daratumumab, bortezomib, dexamethasone, ixazomib)Experimental Treatment5 Interventions

Patients receive daratumumab IV over 3.5-6.5 hours on days 1, 8, and 15, bortezomib SC on days 1, 4, 8, and 11, and dexamethasone IV over 15 minutes on days 1, 8, and 15 and PO on days 2, 4, 5, 9, 11, 12, and 16. Treatment repeats every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive daratumumab IV over 3.5 hours on days 1 and 15 of cycles 4-7 and day 1 of subsequent cycles, ixazomib PO on days 1, 8, and 15, and dexamethasone IV over 15 minutes or PO once weekly. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2590

Daratumumab

2014

Completed Phase 3

~1860

Bortezomib

2005

Completed Phase 2

~1140

Ixazomib

2017

Completed Phase 4

~3370

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,965 Previous Clinical Trials

1,804,877 Total Patients Enrolled

76 Trials studying Multiple Myeloma

5,777 Patients Enrolled for Multiple Myeloma

TakedaIndustry Sponsor

1,201 Previous Clinical Trials

4,178,243 Total Patients Enrolled

50 Trials studying Multiple Myeloma

18,193 Patients Enrolled for Multiple Myeloma

Hans C LeePrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

61 Total Patients Enrolled

1 Trials studying Multiple Myeloma

40 Patients Enrolled for Multiple Myeloma

Media Library

Bortezomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03763162 — Phase 2

Multiple Myeloma Research Study Groups: Treatment (daratumumab, bortezomib, dexamethasone, ixazomib)

Multiple Myeloma Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT03763162 — Phase 2

Bortezomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03763162 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What health issues is Quality-of-Life Assessment typically utilized to address?

"Quality-of-Life Assessment can be employed to manage ophthalmia, sympathetic issues, branch retinal vein occlusions, and macular edema."

Answered by AI

What is the upper limit of participants involved in this research?

"Affirmative. Information posted on clinicaltrials.gov reveals that this experiment is actively seeking participants, having been initially published on January 17th 2019 and recently revised October 12th 2022. The research project needs 60 volunteers from one single site to complete its objectives."

Answered by AI

Has Quality-of-Life Assessment been studied as part of other medical experiments?

"Currently, there are 666 total studies dedicated to Quality-of-Life Assessment. Of those trials, 153 have entered Phase 3 and 21947 locations are hosting them. Joliet, Illinois is the main hub for these investigations."

Answered by AI

Are there any open recruitment opportunities to participate in this trial?

"Verified. According to the details posted on clinicaltrials.gov, this trial is seeking participants and was initially published in January of 2019 with its most recent update occurring in October 2022."

Answered by AI

What risks should be considered when evaluating Quality-of-Life Assessment?

"Due to the Phase 2 trial for Quality-of-Life Assessment, our team at Power evaluated its safety with a score of 2. This is because there exists some data that suggests it may be safe but no evidence supporting efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Daratumumab, Bortezomib, and Dexamethasone Followed by Daratumumab, Ixazomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

2019. "Daratumumab, Bortezomib, and Dexamethasone Followed by Daratumumab, Ixazomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03763162.

All > Velcade