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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
8%
Renal insufficiency
4%
SupraVentricular Tachycardia
4%
Alerted mental status
4%
Posterior Reversible Encephalopathy Syndrome
4%
Gastrointestinal bleed
4%
Respiratory failure
4%
Hypokalemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Patients With Sickle Cell Anemia

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
Melphalan
2008
Completed Phase 3
~1500
Pegfilgrastim
2013
Completed Phase 3
~4410

Find a Location

Who is running the clinical trial?

Spectrum Pharmaceuticals, IncIndustry Sponsor
82 Previous Clinical Trials
8,143 Total Patients Enrolled
1 Trials studying Multiple Myeloma
8 Patients Enrolled for Multiple Myeloma
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,574 Total Patients Enrolled
80 Trials studying Multiple Myeloma
86,121 Patients Enrolled for Multiple Myeloma
Heather Landau, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
7 Previous Clinical Trials
622 Total Patients Enrolled
6 Trials studying Multiple Myeloma
605 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of Captisol Enabled Melphalan and Pharmacokinetics for Patients With Multiple Myeloma or Light Chain Amyloidosis That Are Receiving an Autologous Transplant.
2016. "Study of Captisol Enabled Melphalan and Pharmacokinetics for Patients With Multiple Myeloma or Light Chain Amyloidosis That Are Receiving an Autologous Transplant.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02909036.
All > Al Amyloidosis > Amyloidosis
~2 spots leftby Sep 2024
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