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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

Must not have

Other malignancy with life expectancy < 1 year due to the other malignancy

Human immunodeficiency virus (HIV), or active hepatitis B or C infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have another cancer that is expected to affect my life for less than a year.

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I do not have HIV or active hepatitis B or C.

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I had a stem cell transplant less than 12 weeks ago.

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I had a stem cell transplant and am on high-dose meds for graft vs. host disease.

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I haven't had major surgery or most types of radiation in the last 2 weeks.

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I have bleeding issues that are not helped by platelet transfusions.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Actionable assay result

Secondary study objectives

Overall response rate to the therapy chosen after performing the assay

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~2030

0 / 11Eligibility criteria met