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NCT02909036 · ClinicalTrials.gov registry record · Phase 1
Study of Captisol Enabled Melphalan and Pharmacokinetics for Patients With Multiple Myeloma or Light Chain Amyloidosis That Are Receiving an Autologous Transplant.
A Phase 1 study of Multiple Myeloma and Amyloidosis, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT02909036: Active Phase 1 study of Multiple Myeloma and Amyloidosis, sponsored by Memorial Sloan Kettering Cancer Center.
NCT02909036 is a Phase 1 study of Multiple Myeloma and Amyloidosis that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 46 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02909036, a Phase 1 study of Multiple Myeloma and Amyloidosis, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
defined as stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) to high-dose CE melphalan in patients enrolled in the study between days 90-100 post-AHCT. Responses will be evaluated by the IMWG Response Criteria and Minor Response (MR) criteria. Responses will be evaluated by the standard AL Amyloid Organ Response Criteria.
Conditions Studied
Interventions
- DEVICE Melphalan
- DRUG Pegfilgrastim
- PROCEDURE Autologous Hematopoietic Progenitor Cell Transplant
Study Locations (1)
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2016-09 |
| Est. Completion | 2026-09 |
| Phase | Phase 1 |
What the registry record for NCT02909036 still lists
NCT02909036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 3 interventions - of which Melphalan is the first listed.
NCT02909036 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02909036 about?
NCT02909036 is a clinical study titled "Study of Captisol Enabled Melphalan and Pharmacokinetics for Patients With Multiple Myeloma or Light Chain Amyloidosis That Are Receiving an Autologous Transplant.". 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 al...
What is the current status of trial NCT02909036?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2016-09. Estimated completion is 2026-09.
What conditions does trial NCT02909036 study?
This clinical trial studies the following conditions: Multiple Myeloma, Amyloidosis.
What interventions are being tested in trial NCT02909036?
The interventions under investigation include: Melphalan (DEVICE), Pegfilgrastim (DRUG), Autologous Hematopoietic Progenitor Cell Transplant (PROCEDURE).
Who is sponsoring clinical trial NCT02909036?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02909036 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02909036's enrollment target sits among peer trials
46 270th of 438 higher than 167 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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