CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Cyclophosphamide +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01955434
NCT01955434Phase 2Completed

Phase II Study of LCL161 Alone and in Combination With Cyclophosphamide in Patients With Relapsed or Refractory Multiple Myeloma

Mayo Clinic·interventional·Posted Oct 7, 2013·Updated Sep 10, 2019

In Brief

A Phase 2 clinical trial evaluating Cyclophosphamide, Laboratory Biomarker Analysis, and 3 other interventions for Recurrent Plasma Cell Myeloma and Refractory Plasma Cell Myeloma. Completed, enrolled 25 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 7, 2013
Enrollment StartNov 1, 2013
Primary CompletionJun 9, 2016
Study CompletionDec 27, 2016
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 12.7 years ago

Interventions

Cyclophosphamidedrug

Given PO

Laboratory Biomarker Analysisother

Correlative studies

Pharmacological Studyother

Correlative studies

Quality-of-Life Assessmentother

Ancillary studies

Smac Mimetic LCL161drug

Given PO