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Alkylating Agent

Ixazomib + Cyclophosphamide + Dexamethasone for Multiple Myeloma

Phase 1 & 2
Waitlist Available
Led By Shaji Kumar
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male patients: even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:
Female patients: if they are of childbearing potential, agree to one of the following:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I am a male and agree to follow the birth control requirements.
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I agree to follow one of the birth control methods if I can have children.
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I agree to practice true abstinence as a form of contraception.
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I agree to practice true abstinence as a form of contraception.
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I have multiple myeloma and am interested in Phase I, Cohort A.
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I have amyloidosis affecting my organs and need treatment.
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I had treatment for solitary plasmacytoma over 14 days ago. I may have used specific allowed medications.
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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.
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My multiple myeloma can be measured by medical tests.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
Pharmacokinetic (PK) Parameters
Quality of Life, as Assessed by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire

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
Dexamethasone
2007
Completed Phase 4
~2590
Cyclophosphamide
1995
Completed Phase 3
~3780
Ixazomib Citrate
2012
Completed Phase 2
~200

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,757,964 Total Patients Enrolled
75 Trials studying Multiple Myeloma
9,424 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,559 Total Patients Enrolled
572 Trials studying Multiple Myeloma
187,898 Patients Enrolled for Multiple Myeloma
Shaji KumarPrincipal InvestigatorMayo Clinic
15 Previous Clinical Trials
1,607 Total Patients Enrolled
15 Trials studying Multiple Myeloma
1,607 Patients Enrolled for Multiple Myeloma

Media Library

Cyclophosphamide (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT01864018 — Phase 1 & 2
Multiple Myeloma Research Study Groups: Treatment (ixazomib citrate, cyclophosphamide, dexamethasone)
Multiple Myeloma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT01864018 — Phase 1 & 2
Cyclophosphamide (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01864018 — Phase 1 & 2

Frequently Asked Questions

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

Is there capacity for additional participants in this clinical experiment?

"Unfortunately, this clinical trial is no longer open for new enrollees. The protocol was published on August 20th 2013 and had its last amendment submitted on 25th of August 2022. Fortunately, there are currently 905 studies recruiting participants with amyloidosis and 1296 trials looking to recruit candidates for Pharmacological Study."

Answered by AI

What key objectives is this clinical experiment striving to achieve?

"The main target of this nearly year-long trial is to establish the Maximum Tolerable Dose (MTD) of Cyclophosphamide. To evaluate treatment efficacy, secondary objectives including Progression Free Survival rate, overall Survival Time and Number of Patients with Grade 3 or Higher Adverse Events will be measured according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0. These grades indicate a severe but non-life threatening medical issue that require hospitalization or prolongation of it; disabling symptoms; and limiting self care ability as per daily activities definition."

Answered by AI

Could you provide an overview of the existing research on Pharmacological Study?

"Currently, there are 1,296 pharmacological studies underway worldwide with 270 of them in their final phase. Most notably, Philadelphia is running a significant amount of trials for this medical intervention with 41,819 total locations conducting research on the subject matter."

Answered by AI

How many participants have so far enrolled in this experiment?

"At present, this trial is not accepting any more patients. It was first published on August 20th 2013 and the last update occurred on August 25th 2022. However, those interested in participating in clinical studies may want to consider looking into 905 amyloidosis-related trials or 1296 drug research initiatives that are currently enrolling volunteers."

Answered by AI

What common health issues are addressed through Pharmacological Study?

"Pharmacological Study is traditionally prescribed to treat synovitis, but it has also been found effective at treating ophthalmia and sympathetic disorders, as well as certain types of cancer like lung cancer and branch retinal vein occlusion."

Answered by AI
~8 spots leftby Mar 2025