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Alkylating Agent

Ixazomib + Cyclophosphamide + Dexamethasone for Multiple Myeloma

Phase 1 & 2

Waitlist Available

Led By Shaji Kumar, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Calculated creatinine clearance (using Cockcroft-Gault equation) >= 30 mL/min

Previously untreated

Must not have

Peripheral neuropathy >= grade 3 on clinical examination or grade 2 with pain during the screening period

Major surgery =< 14 days prior to study registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing cyclophosphamide given with ixazomib citrate and dexamethasone to see what effects, good and bad, it has in treating patients with previously untreated multiple myeloma or light chain amyloidosis.

Who is the study for?

This trial is for adults with untreated symptomatic multiple myeloma or light chain amyloidosis. Participants must have certain levels of monoclonal protein, adequate organ function, and agree to use effective contraception. Exclusions include recent major surgery, other serious illnesses, prior treatments for the conditions outside protocol guidelines, known allergies to study drugs, uncontrolled diseases like heart disease or infections.

What is being tested?

The trial tests a combination of Ixazomib Citrate with Cyclophosphamide and Dexamethasone in patients who haven't been treated before for their condition. It's designed to find out the best dose of Cyclophosphamide and how these drugs work together against cancer cells by stopping their growth.

What are the potential side effects?

Potential side effects may include reactions related to chemotherapy such as nausea, hair loss, increased risk of infection due to low blood cell counts; Ixazomib-related issues like gastrointestinal symptoms or skin rash; and steroid effects from Dexamethasone including mood swings or increased blood sugar.

Eligibility Criteria

Inclusion Criteria

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

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My kidneys are functioning well enough, with a creatinine clearance of at least 30 mL/min.

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I have not received any treatment for my condition.

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

Exclusion Criteria

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

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I have severe nerve pain or numbness in my hands or feet.

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I have not had major surgery in the last 14 days.

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I have been diagnosed with MGUS or smoldering myeloma.

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I do not have severe heart problems or recent heart attacks.

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I have a stomach or intestine condition that affects how I absorb pills or makes it hard for me to swallow.

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I have mild to no diarrhea without taking medication for it.

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I am HIV positive.

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I am of childbearing age and do not plan to use birth control.

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I am currently breastfeeding.

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

Study Objectives

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

Primary study objectives

Cyclophosphamide

Maximum Tolerated (MTD) Dose of Cyclophosphamide With Ixazomib and Dexamethasone (Phase I)

Percentage of Patients With Complete Response or Very Good Partial Response (Phase II, Cohort A)

+1 more

Secondary study objectives

Number of Patients Experiencing a Grade 3 or Greater Adverse Event at Least Possibly Related to Treatment as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

Progression-free Survival (PFS)

Survival Time

Other study objectives

Pharmacokinetic (PK) Parameters

Quality of Life, as Assessed by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire

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: Treatment (ixazomib citrate, cyclophosphamide, dexamethasone)Experimental Treatment7 Interventions

INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses 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

Cyclophosphamide

2010

Completed Phase 4

~2310

Dexamethasone

2007

Completed Phase 4

~2650