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Alkylating agents

Melphalan for Multiple Myeloma

Phase 1

Waitlist Available

Led By Heather Landau, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients receiving high-dose melphalan and AHCT as part of salvage therapy require at least a minor response to their last line of therapy to document chemosensitive disease

A willingness to avoid pregnancy or fathering children in male and female subjects respectively

Must not have

Unstable angina or myocardial infarction within 4 months of initiating therapy on trial, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker

Light chain (AL) amyloidosis patients with Mayo Cardiac Stage IIIB

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

No Placebo-Only Group

Summary

This trialtests a new form of chemo that may be more stable & have fewer side effects, to treat types of cancer.

Who is the study for?

This trial is for adults aged 18-75 with Multiple Myeloma or AL Amyloidosis who are undergoing an autologous transplant and have responded to prior chemotherapy. They must have adequate organ function, a certain number of cells available for transplant, and agree to avoid pregnancy. Excluded are those with recent heart issues, severe heart failure, other cancers within 3 years (with some exceptions), known allergies to the study drugs, or unsuitable conditions as determined by physicians.

What is being tested?

The trial is testing Captisol Enabled Melphalan—a new formulation of melphalan chemotherapy thought to be more stable and potentially less harmful to kidneys and heart—alongside Pegfilgrastim support during autologous hematopoietic progenitor cell transplant. The goal is finding the optimal level of this drug for treating Multiple Myeloma and AL Amyloidosis.

What are the potential side effects?

Potential side effects may include fewer problems with body electrolyte levels like potassium, phosphorous, magnesium; reduced risk of kidney and heart damage compared to standard melphalan; however specific side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

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

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My last cancer treatment showed some positive response.

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I am willing to prevent pregnancy or fathering children during the trial.

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Your liver, kidney, heart, and lung function tests should be within normal range.

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I can take care of myself but might not be able to do heavy physical work.

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I am between 18 and 75 years old.

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I have multiple myeloma and responded well to previous chemotherapy.

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I have been diagnosed with multiple myeloma or AL amyloidosis.

Exclusion Criteria

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

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I haven't had recent severe heart issues or uncontrolled heart conditions.

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My condition is advanced AL amyloidosis affecting my heart.

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I am allergic to or cannot have certain cancer treatments, including G-CSF or pegfilgrastim.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 day

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

Treatment Details

Study Objectives

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

Primary study objectives

Overall Response Rate (ORR)

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: MelphalanExperimental Treatment3 Interventions

Test Dose CE Melphalan 10mg/m2 with PK studies Day -12 to Day-3, CE Melphalan Dose of Target AUC 13 mg/L/h infused with PK studies Day -2, 3-10 x 10\^6 CD 34+ cells/kg reinfused Day 0, Pegfilgrastim 6mg injection Day +1

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pegfilgrastim

2013

Completed Phase 3

~4440

Melphalan

2008

Completed Phase 3

~1500