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Individualized Treatment Plans for Multiple Myeloma

N/A

Recruiting

Led By Andrew J. Cowan

Research Sponsored by University of Washington

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3

- Circulating plasma cells >= 2,000 if diagnosis of plasma cell leukemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing whether high-throughput drug sensitivity and genomics data can be used to develop individualized treatment plans for patients with multiple myeloma or plasma cell leukemia.

Who is the study for?

This trial is for adults with relapsed or refractory multiple myeloma or plasma cell leukemia who have tried at least three prior treatments, including an IMiD and a PI. They must be able to consent, practice birth control if applicable, have adequate organ function, and measurable disease. Excluded are those with HIV/hepatitis B/C, recent major treatments like SCT within 12 weeks, active infections requiring antibiotics within 7 days of study start.Check my eligibility

What is being tested?

The trial tests the feasibility of using high throughput drug sensitivity screening alongside genomics data to personalize treatment for patients whose multiple myeloma or plasma cell leukemia has returned after treatment or is resistant. It involves collecting samples from patients and testing many drugs simultaneously to find effective ones based on genetic information.See study design

What are the potential side effects?

Since this trial focuses on individualized treatment plans derived from lab analysis rather than specific medications, side effects will vary depending on which drugs are selected as potential treatments for each participant.

Eligibility Criteria

Inclusion Criteria

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

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I can care for myself but may not be able to do heavy physical work.

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I have been diagnosed with plasma cell leukemia and have at least 2,000 circulating plasma cells.

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I have had at least 3 treatments including IMiD and PI for my condition.

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My multiple myeloma or plasma cell leukemia has returned or did not respond to treatment.

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My cancer can be felt through a physical exam or seen on scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Actionable assay result

Secondary outcome measures

Overall response rate to the therapy chosen after performing the assay

Trial Design

1Treatment groups

Experimental Treatment

Group I: Device feasibility (high-throughput assay, sequencing)Experimental Treatment3 Interventions

Patients undergo collection of bone marrow aspirate and blood for high-throughput drug sensitivity assay and mutational analysis using next generation sequencing. Patients and their treating physicians receive the results of the tests. Treatment decisions are then made by the patients and their treating physicians.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1730

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,740 Previous Clinical Trials

1,847,630 Total Patients Enrolled

8 Trials studying Multiple Myeloma

429 Patients Enrolled for Multiple Myeloma

Andrew J. CowanPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

1 Previous Clinical Trials

37 Total Patients Enrolled

1 Trials studying Multiple Myeloma

37 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

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

Are there still vacancies within this clinical investigation?

"It is evident from clinicaltrials.gov that this research project, which was first unveiled on February 14th 2018, is actively recruiting participants. The latest update to the study's entry occurred on October 19th 2022."

Answered by AI

What is the suggested enrollment of participants for this research?

"Affirmative. Research hosted on clinicaltrials.gov indicates that this trial is actively seeking volunteers, with the initial post being dated February 14th 2018 and the most recent update occuring October 19th 2022. 30 patients are needed to be enrolled at a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

High Throughput Drug Sensitivity and Genomics Data in Developing Individualized Treatment in Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia

2018. "High Throughput Drug Sensitivity and Genomics Data in Developing Individualized Treatment in Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03389347.

All > Plasma Cell Leukemia