NCT02909036

Study of Captisol Enabled Melphalan and Pharmacokinetics for Patients With Multiple Myeloma or Light Chain Amyloidosis That Are Receiving an Autologous Transplant.

Pharmacokinetic (PK)-Directed Dosing of Captisol Enabled Melphalan for Patients With Multiple Myeloma or Light Chain (AL) Amyloidosis Undergoing High Dose Therapy and Autologous Hematopoietic Progenitor Cell Transplant

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Captisol Enabled Melphalan, is a new formulation of the standard of care melphalan chemotherapy that in packaged in an inactive substance that is believed to help the chemotherapy be more stable (meaning that it doesn't lose its effect or need to be administered quickly after being mixed). It may also have fewer side effects such as problems with important levels of body electrolytes such as potassium, phosphorous and magnesium; and cause less kidney and heart damage\] than standard formulation melphalan. The purpose of this study is to determine if the investigators can achieve a certain level of Captisol Enabled Melphalan that would be best to use in treating Multiple Myeloma and AL Amyloidosis.

Conditions

• Multiple Myeloma
• Amyloidosis

Interventions

Type	Name	Description
DEVICE	Melphalan
DRUG	Pegfilgrastim
PROCEDURE	Autologous Hematopoietic Progenitor Cell Transplant

Timeline

• Start date: 2016-09-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2016-09-21
• Last updated: 2025-10-10

Locations

1 site across 1 country: United States