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Alkylating agents

Evomela + Fludarabine + TBI for Multiple Myeloma

Phase 2

Recruiting

Led By Mehdi Hamadani

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

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

Must have

No evidence of uncontrolled bacterial, viral or fungal infections at the time of enrollment

Left ventricular ejection fraction ≥40%. No uncontrolled arrhythmias or New York Heart Association class III-IV heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year and 2 year

Awards & highlights

Study Summary

This trial is testing a new cancer treatment that uses a different form of melphalan than what is typically used, in combination with fludarabine and total-body irradiation-based reduced-intensity conditioning, in order to see if it is effective and safe.

Who is the study for?

This trial is for adults with blood cancers like multiple myeloma who need a haploidentical transplant. They should have good heart and lung function, stable liver and kidney health, no uncontrolled infections or serious illnesses, and agree to use effective contraception.Check my eligibility

What is being tested?

The study tests EVOMELA® combined with Fludarabine and Total Body Irradiation as a conditioning treatment before haploidentical transplantation. It's an open-label phase II trial focusing on safety and one-year progression-free survival rates.See study design

What are the potential side effects?

Potential side effects may include reactions related to bone marrow suppression such as fatigue, infection risk increase; organ toxicity affecting the heart, lungs or liver; nausea; mouth sores from chemotherapy; skin changes due to radiation.

Eligibility Criteria

Inclusion Criteria

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

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I do not have any ongoing serious infections.

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My heart pumps well and I don't have severe heart issues or uncontrolled irregular heartbeats.

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My kidneys work well enough, with a creatinine clearance over 30 mL/min.

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

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I have a blood cancer and am getting a stem cell transplant from a family member.

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My transplant used cells from blood or bone marrow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year and 2 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year and 2 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year and 2 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Progression-free survival (PFS) of participants with hematological malignancies undergoing treatment.

The safety of this trial will be evaluated with the nonrelapse mortality rate.

Secondary outcome measures

Acute graft-versus-host disease (GVHD) at day 100 and 180.

Neutrophil recovery

Number of subjects with relapse of disease.

+4 more

Side effects data

From 2021 Phase 3 trial • 30 Patients • NCT01877837

36%

Infection (grade 3 and above)

24%

Graft versus host disease

Renal insufficiency

SupraVentricular Tachycardia

Alerted mental status

Posterior Reversible Encephalopathy Syndrome

Gastrointestinal bleed

Respiratory failure

Hypokalemia

100%

80%

60%

40%

20%

Study treatment Arm

Patients With Sickle Cell Anemia

Trial Design

1Treatment groups

Experimental Treatment

Group I: MEL/FLU and Total-Body Irradiation (TBI)Experimental Treatment3 Interventions

For patients who are < 60 years. Melphalan: 140 mg/m2/day IV on Day: -6 Fludarabine: 40 mg/ m2/day IV Days: -5 -4, -3, -2 (Adults: creatinine clearance (CrCl) may be estimated by the Cockcroft Formula: CrCl = [(140-age) x weight (kg) x 0.85 (for women only)]/ [72 x creat (mg/dl)].) TBI: 200 cGy Day: -1. For patients who are ≥60 years and/or Hematopoietic Cell Transplant-Co-morbidity Index (HCT-CI) score of >3 (at the discretion of treating physician will have an option to receive): Melphalan: 70 mg/m2/day IV on Day -6. Fludarabine: 40 mg/m2/day IV Days -5, -4, -3, -2. TBI: 200 cGy; Days -1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 3

~1080

Total Body Irradiation

2006

Completed Phase 3

~820

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

610 Previous Clinical Trials

1,162,670 Total Patients Enrolled

Mehdi HamadaniPrincipal Investigator - Medical College of Wisconsin

Froedtert & The Medical College of Wisconsin

Media Library

Blood Cancers Research Study Groups: MEL/FLU and Total-Body Irradiation (TBI)

Frequently Asked Questions

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

How many volunteers have enrolled in this clinical research?

"Affirmatively, the information hosted on clinicaltrials.gov proves that this trial is actively enrolling patients; it was first posted on December 8th 2017 and recently adjusted on October 4th 2022 with a goal of recruiting 43 participants from 1 medical centre."

Answered by AI

To what extent does Fludarabine pose a threat to human health?

"Our team at Power rated the safety of Fludarabine as a 2 in light of this Phase 2 clinical trial which has some evidence supporting its security profile, yet no data confirming efficacy."

Answered by AI

Is recruitment for this experiment still taking place?

"Indeed, the clinicaltrials.gov database reveals that this medical trial is still open for recruitment and was first released on 8th December 2017. The study has since been updated on 4th October 2022 and seeks 43 participants from one single site."

Answered by AI

What are the desired results of this research endeavor?

"This biomedical investigation, lasting approximately one year, will monitor Progression-Free Survival (PFS) among patients with hematological malignancies. Secondary endpoints include Neutrophil Recovery time, Primary Graft failure rate, and Number of Relapsed Disease instances."

Answered by AI

How is Fludarabine commonly employed in medicine?

"Fludarabine has been demonstrated to have therapeutic value in the management of chronic lymphocytic leukemia, stem cell transplantation and amyloidosis."

Answered by AI

Recent research and studies

Biology of Blood and Marrow TransplantationJournal

Outcomes of Haploidentical Stem Cell Transplantation for Lymphoma with Melphalan-based Conditioning

Brammer, Jonathan E., Issa Khouri, Sameh Gaballa, Paolo Anderlini, Ciprian Tomuleasa, Sairah Ahmed, Celina Ledesma, Chitra Hosing, Richard E. Champlin, and Stefan O. Ciurea. 2016. “Outcomes of Haploidentical Stem Cell Transplantation for Lymphoma with Melphalan-based Conditioning”. Biology of Blood and Marrow Transplantation. Elsevier BV. doi:10.1016/j.bbmt.2015.10.015.

Bone Marrow TransplantationJournal

van Besien, K, S Devine, A Wickrema, E Jessop, K Amin, M Yassine, V Maynard, et al.. 2003. “Regimen-related Toxicity After Fludarabine–melphalan Conditioning: A Prospective Study of 31 Patients with Hematologic Malignancies”. Bone Marrow Transplantation. Springer Science and Business Media LLC. doi:10.1038/sj.bmt.1704166.

clinicaltrials.govStudy

Propylene Glycol-Free Melphalan HCl (EVOMELA®) in Combination With Fludarabine and Total Body Irradiation Based Reduced Intensity Conditioning for Haploidentical Transplantation

Mehdi Hamadani 2017. "Propylene Glycol-Free Melphalan HCl (EVOMELA®) in Combination With Fludarabine and Total Body Irradiation Based Reduced Intensity Conditioning for Haploidentical Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03159702.

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