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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

Must not have

Presence of active disease in acute myeloid leukemia (AML)/myelodysplastic syndrome (MDS)

Patient must not have a healthy, eligible and readily available HLA-identical sibling donor or a volunteer adult unrelated donor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year and 2 year

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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My condition is active AML or MDS.

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I do not have a suitable family or unrelated donor for a transplant.

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

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

Primary study objectives

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 study objectives

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

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: 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 4

~1860

Total Body Irradiation

2006

Completed Phase 3

~820