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

StatusActive, Not Recruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 2026 → Sep 2027
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Record History

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  1. Primary and study completion pushed from Sep 2026 to Sep 2027
    • Eligibility criteria expanded, about 24 words
  2. Primary and study completion dates: Sep 2025 to Sep 2026v17
  3. Primary and study completion dates: Sep 2024 to Sep 2025v16
  4. Primary and study completion dates: Sep 2023 to Sep 2024v15
  5. Primary and study completion dates: Sep 2022 to Sep 2023v14
Show 12 earlier versionsHide 12 earlier versions
  1. Re-verified, no change to tracked fieldsv13
  2. Primary and study completion dates: Sep 2021 to Sep 2022v12
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v11
  4. Primary and study completion dates: Sep 2019 to Sep 2021v10
  5. Enrollment target: 26 to 46v9
  6. Eligibility criteria revisedv8
  7. Enrollment target: 16 to 26v7
  8. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v6
  9. Primary and study completion dates: Sep 2018 to Sep 2019
    • Enrollment target: 11 to 16
    v5
  10. Re-verified, no change to tracked fieldsv4
  11. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 15 to confirmed 11
    • Study completion date: Sep 2018
    • Site details revised
    v3
  12. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02909036
Lead Sponsor Memorial Sloan Kettering Cancer Center
Collaborators: Spectrum Pharmaceuticals, Inc
Conditions
(from sponsor)		 Multiple Myeloma, Amyloidosis
Related terms Amyloidosis, Multiple Myeloma
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov