CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 83 enrolled
Drug / intervention
Busulfan +6 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/NCT02506959
NCT02506959Phase 2Completed

Panobinostat Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant for Patients With Refractory/Relapsed Myeloma

M.D. Anderson Cancer Center·interventional·Posted Jul 23, 2015·Updated Mar 18, 2025

In Brief

A Phase 2 clinical trial evaluating Autologous Hematopoietic Stem Cell Transplantation, Busulfan, and 5 other interventions for Plasma Cell Leukemia and 3 related conditions. Completed, enrolled 83 participants across 1 site.

Detailed Summary

This phase II trial studies how well panobinostat, gemcitabine hydrochloride, busulfan, and melphalan before stem cell transplant work in treating patients with multiple myeloma that does not respond to treatment (refractory) or has returned (relapsed). Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving high-dose chemotherapy, such as gemcitabine hydrochloride, busulfan, and melphalan, before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Previously collected stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

Study Details

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

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 23, 2015
Enrollment StartSep 14, 2015
Primary CompletionJun 3, 2024
TodayJul 2, 2026
Enrollment to primary: 8.7 yearsPosted 10.9 years ago

Interventions

Autologous Hematopoietic Stem Cell Transplantationprocedure

Undergo autologous peripheral blood stem cell transplant

Busulfandrug

Given IV

Gemcitabine Hydrochloridedrug

Given IV

Melphalandrug

Given IV

Panobinostatdrug

Given PO

Peripheral Blood Stem Cell Transplantationprocedure

Undergo autologous peripheral blood stem cell transplant

Pharmacological Studyother

Correlative studies