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NCT01237951

High-Dose Gemcitabine, Busulfan and Melphalan With Hematopoietic-Cell Support for Patients With Poor-Risk Myeloma

Completed Phase 2 Results posted Last updated 5 May 2020
What this trial tests

Phase 2 trial testing Palifermin in Myeloma in 75 participants. Completed in 20 September 2017.

Timeline
8 November 2010
Primary endpoint
20 September 2017
20 September 2017

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment75
Start date8 November 2010
Primary completion20 September 2017
Estimated completion20 September 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

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 Remission Primary · 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.

GroupValue95% CI
Gemcitabine/Busulfan/Melphalan16
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

GroupValue95% CI
Gemcitabine/Busulfan/Melphalan31
Overall Survival Secondary · 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

GroupValue95% CI
Gemcitabine/Busulfan/Melphalan49
Percent of Participants Dying From Treatment-Related Complications Secondary · 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.

GroupValue95% CI
Gemcitabine/Busulfan/Melphalan4

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.

Gemcitabine/Busulfan/Melphalan
Serious: 31/74 (42%)
Deaths: 5/75

Serious adverse events (6 terms)

ReactionSystemGemcitabine/Busulfan/Melph…
MucositisGastrointestinal disorders
HyperbilirubinemiaHepatobiliary disorders
DermatitisSkin and subcutaneous tissue disorders
InfectionInfections and infestations
DiarrheaGastrointestinal disorders
CardiacCardiac disorders
Other adverse events (7 terms — click to expand)

ReactionSystemGemcitabine/Busulfan/Melph…
InfectionImmune system disorders
MucositisGastrointestinal disorders
CardiacCardiac disorders
DermatitisSkin and subcutaneous tissue disorders
DiarrheaGastrointestinal disorders
HyperbilirubinemiaHepatobiliary disorders
Hand-foot syndromeSkin and subcutaneous tissue disorders

Most-reported serious reactions: Mucositis, Hyperbilirubinemia, Dermatitis, Infection, Diarrhea, Cardiac.

Data from ClinicalTrials.gov NCT01237951 adverse events section.

Sponsor's own description

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):

  1. High-dose gemcitabine, busulfan, and melphalan for autologous stem-cell transplant in patients with relapsed or refractory myeloma: a phase 2 trial and matched-pair comparison with melphalan.
    Nieto Y, Valdez BC, Pingali SR, Bassett R, et al · · 2017 · cited 19× · PMID 28522110 · DOI 10.1016/s2352-3026(17)30080-7

Verify or expand the search:

Other trials of Palifermin

Trials testing the same drug.

Other recruiting trials for Myeloma

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing