Adults 18 to 70, any sex, with Myeloma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Participants Who Had Measurable Disease at Time of Transplant and Achieved a Stringent Complete RemissionPrimary· 100 days post-transplant
Stringent complete remission was defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, 5% or fewer plasma cells in bone marrow, normal free light chain ratio, and the absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Group
Value
95% CI
Gemcitabine/Busulfan/Melphalan
16
Progression-free Survival (PFS)Secondary· From date of transplant until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Number of participants remain free of progression or death after ASCT
Group
Value
95% CI
Gemcitabine/Busulfan/Melphalan
31
Overall SurvivalSecondary· From date of transplant until the date of death from any cause, assessed up to 2 years
Number of participants from ASCT to death or last contact
Group
Value
95% CI
Gemcitabine/Busulfan/Melphalan
49
Percent of Participants Dying From Treatment-Related ComplicationsSecondary· From date of transplant until the date of death from treatment-related complications, assessed up to 2 years
Participants who died from treatment-related complications from the time of ASCT.
Group
Value
95% CI
Gemcitabine/Busulfan/Melphalan
4
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 2 years.
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The goal of this clinical research study is to learn if the combination of gemcitabine, busulfan, and melphalan, when given before a stem cell transplant, can help to control refractory myeloma. The safety of this study treatment will also be studied.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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· recruiting
NCT06851767 — Base-Edited Hematopoietic Stem/Progenitor Cell X-Linked Severe Combined Immunodeficiency Gene Therapy
· Phase 1, PHASE2
· enrolling by invitation
NCT06325709 — Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-Linked Chronic Granulomatous Disease
· Phase 1, PHASE2
· recruiting
NCT05139004 — 90Y-DOTA-anti-CD25 Basiliximab, Fludarabine, Melphalan, and Total Marrow and Lymphoid Irradiation for the Treatment of H
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· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 5 May 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01237951.