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Stem Cell Mobilizer

Motixafortide + G-CSF for Multiple Myeloma

Saint Louis, MO

Phase 1

Recruiting

Led By Zachary Crees, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Received ≥3 cycles but ≤6 cycles of daratumumab-based quadruplet induction therapy before ASCT

Subjects should be in first or second CR or PR

Must not have

Received >8 cycles of alkylating agent combinations

Received prior treatment with radioimmunotherapy or venetoclax

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial involves studying the effects of different treatments on stem cells in patients with multiple myeloma. The study will look at how a specific drug called motixafortide affects stem cells when given at

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Who is the study for?

This trial is for multiple myeloma patients who are undergoing standard quad-induction therapy. They will be part of a study to see how different timing of the drug motixafortide, combined with G-CSF, affects stem cell collection in their treatment.Check my eligibility

What is being tested?

The study tests how well motixafortide works when given at 'standard' (~12 hours) vs 'early' (~16 hours) times before collecting stem cells. It also looks at the effects of quad-induction on stem cell types in the mobilized graft from these patients.See study design

What are the potential side effects?

While specific side effects are not listed here, Motixafortide and G-CSF can generally cause bone pain, muscle aches, headaches, nausea and fatigue. The procedure may also have risks associated with apheresis.

Eligibility Criteria

Inclusion Criteria

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

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I've had 3 to 6 rounds of daratumumab-based therapy before stem cell transplant.

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My cancer is responding well to treatment.

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I am fully active or can carry out light work.

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I am between 18 and 78 years old.

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I am not able to become pregnant or have a negative pregnancy test.

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I have multiple myeloma and will undergo high-dose chemotherapy and a stem cell transplant.

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Exclusion Criteria

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

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I have received more than 8 cycles of chemotherapy with alkylating agents.

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I have been treated with radioimmunotherapy or venetoclax before.

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I have active brain metastases or carcinomatous meningitis.

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I do not have an active infection needing treatment.

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I am currently being treated for another cancer.

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I have chronic hepatitis B or C.

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My previous attempts to collect stem cells were unsuccessful.

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I have had a stem cell transplant before.

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I have received more than 6 cycles of melphalan.

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I have had more than 6 treatments with IMiD drugs.

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I have a history of heart conditions.

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I am HIV positive and not on effective HIV treatment.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cohort 2: Early dosingExperimental Treatment2 Interventions

For Cohort 2, motixafortide will be given on Day 4 between 2:00 and 4:00 pm. A second dose may be given on Day 6 with goal of administration between 6:00 and 8:00 pm after completion of pheresis if clinically feasible. if CD34+ cell collection goals are not met on Day 5 apheresis.

Group II: Cohort 1: Standard dosingActive Control2 Interventions

For Cohort 1, motixafortide will be given on Day 4 between 6:00 and 8:00 pm. A second dose may be given on Day 6 between 6:00 and 8:00 p.m. if CD34+ cell collection goals are not met on Day 5 apheresis.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

G-CSF

2014

Completed Phase 4

~1610

0 / 18Eligibility criteria met