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NCT01955434 · ClinicalTrials.gov registry record · Phase 2
SMAC Mimetic LCL161 Alone or With Cyclophosphamide in Treating Patients With Relapsed or Refractory Multiple Myeloma
A Phase 2 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT01955434: Completed Phase 2 study, sponsored by Mayo Clinic.
NCT01955434 is a Phase 2 study that has completed, run by Mayo Clinic. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01955434, a Phase 2 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
This phase II trial studies how well second mitochondrial-derived activator of caspases (SMAC) mimetic LCL161 alone or with cyclophosphamide works in treating patients with multiple myeloma that has returned or does not respond to treatment. Biological therapies, such as SMAC mimetic LCL161, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving SMAC mimetic LCL161 alone or with cyclophosphamide is more effective in treating multiple myeloma.
Primary Outcome
The primary endpoint of this study is the confirmed overall response rate with single agent LCL161 (prior to initiation of cyclophosphamide). A confirmed overall response is defined as sCR (CR as defined+Normal FLC ratio+Absence of clonal PCs by immunohistochemistry), CR (Negative immunofixation of serum and urine+Disappearance of any soft tissue plasmacytoma+\<5% PCs in Bone Marrow+a normal FLC ratio), VGPR (Serum and urine M-component detectable by immunofixation but not on electrophoresis), o
Interventions
- DRUG Cyclophosphamide
- OTHER Quality-of-Life Assessment
- OTHER Laboratory Biomarker Analysis
- OTHER Pharmacological Study
- DRUG Smac Mimetic LCL161
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2013-11 |
| Est. Completion | 2016-12-27 |
| Phase | Phase 2 |
What the finished NCT01955434 record still lists
NCT01955434 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01955434 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01955434 about?
NCT01955434 is a clinical study titled "SMAC Mimetic LCL161 Alone or With Cyclophosphamide in Treating Patients With Relapsed or Refractory Multiple Myeloma". This phase II trial studies how well second mitochondrial-derived activator of caspases (SMAC) mimetic LCL161 alone or with cyclophosphamide works in treating patients with multiple myeloma that has returned or does not respond to treatment. Biological therapies, such as SMAC mimetic LCL161, may sti...
What is the current status of trial NCT01955434?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2013-11. Estimated completion is 2016-12-27.
What interventions are being tested in trial NCT01955434?
The interventions under investigation include: Cyclophosphamide (DRUG), Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Pharmacological Study (OTHER), Smac Mimetic LCL161 (DRUG).
Who is sponsoring clinical trial NCT01955434?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01955434's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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