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NCT04682405

Uproleselan (GMI-1271) for GI Toxicity Prophylaxis During Melphalan-Conditioned Autologous Hematopoietic Cell Transplantation (Auto-HCT) for Multiple Myeloma (MM)

Completed Phase 2 Results posted Last updated 15 December 2023
What this trial tests

Phase 2 trial testing Uproleselan in Multiple Myeloma in 51 participants. Completed in 11 November 2022.

Timeline
5 May 2021
Primary endpoint
11 November 2022
11 November 2022

Quick facts

Lead sponsorWashington University School of Medicine
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposesupportive care
Enrollment51
Start date5 May 2021
Primary completion11 November 2022
Estimated completion11 November 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Washington University School of Medicine

Who can join

Adults 18 to 75, any sex, with Multiple 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.

Change in Diarrhea as Assessed Per CTCAE v5.0 Primary · From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

Grade 0 is defined as no diarrhea, or no change from baseline. Grade 1 is defined as an increase of \<4 stools per day over baseline; mild increase in ostomy output compared to baseline. Grade 2 is defined as an increase of 4-6 stools per day over baseline; moderate increase in ostomy output compared to baseline; limiting instrumental ADL. Grade 3 is defined as an increase of \>=7 stools per day over baseline; hospitalization indicated; severe increase in ostomy output compared to baseline; limited self care ADL. Grade 4 is defined as life-threatening consequences; urgent intervention indicate

Day -3
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.13± 0.34
Day -2
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.13± 0.34
Day -1
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.31± 0.55
Placebo + Standard of Care Melphalan0.38± 0.58
Day 0
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.19± 0.40
Placebo + Standard of Care Melphalan0.21± 0.41
Day 1
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.23± 0.51
Placebo + Standard of Care Melphalan0.25± 0.53
Day 2
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.42± 0.58
Placebo + Standard of Care Melphalan0.46± 0.66
Day 3
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.65± 0.75
Placebo + Standard of Care Melphalan0.88± 0.85
Day 4
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.88± 0.71
Placebo + Standard of Care Melphalan1.08± 1.02
Change in Oral Mucositis as Assessed Per CTCAE v5.0 Secondary · From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

Grade 0 oral mucositis is defined as no presence of mucositis. Grade 1 oral mucositis is defined as asymptomatic or mild symptoms; intervention not indicated. Grade 2 oral mucositis is defined as moderate pain or ulcer that does not interfere with oral intake; modified diet indicated. Grade 3 oral mucositis is defined as severe pain; interfering with oral intake. Grade 4 oral mucositis is defined as life-threatening consequences; urgent intervention indicated. Grade 5 oral mucositis is defined as death.

Day -3
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.04± 0.20
Day -2
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.04± 0.20
Day -1
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day 0
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.08± 0.28
Day 1
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.08± 0.28
Day 2
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.12± 0.33
Placebo + Standard of Care Melphalan0.08± 0.28
Day 3
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.16± 0.33
Placebo + Standard of Care Melphalan0.04± 0.20
Day 4
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.08± 0.27
Placebo + Standard of Care Melphalan0.08± 0.28
Change in Esophagitis as Assessed Per CTCAE v5.0 Secondary · From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

Grade 0 esophagitis is defined as no presence of esophagitis. Grade 1 esophagitis is defined as asymptomatic; clinical or diagnostic observations only; intervention not indicated. Grade 2 esophagitis is defined as symptomatic; altered GI function; limiting instrumental ADL. Grade 3 esophagitis is defined as severely altered GI function; TPN indicated; elective invasive intervention indicated; limiting self care ADL. Grade 4 esophagitis is defined as life-threatening consequences; urgent operative intervention indicated. Grade 5 esophagitis is defined as death.

Day -3
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day -2
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day -1
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day 0
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day 1
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day 2
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.08± 0.27
Placebo + Standard of Care Melphalan0.00± 0.00
Day 3
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.04± 0.20
Placebo + Standard of Care Melphalan0.00± 0.00
Day 4
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.04± 0.20
Placebo + Standard of Care Melphalan0.04± 0.20
Change in Gastritis as Assessed Per CTCAE v5.0 Secondary · From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

Grade 0 gastritis is defined as no presence of esophagitis. Grade 1 gastritis is defined as asymptomatic; clinical or diagnostic observations only; intervention not indicated. Grade 2 gastritis is defined as symptomatic; altered GI function; medical intervention indicated. Grade 3 gastritis is defined as severely altered eating or gastric function; TPN or hospitalization indicated. Grade 4 gastritis is defined as life-threatening consequences; urgent operative intervention indicated. Grade 5 gastritis is defined as death.

Day -3
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day -2
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day -1
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day 0
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day 1
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.04± 0.20
Placebo + Standard of Care Melphalan0.04± 0.20
Day 2
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.15± 0.46
Placebo + Standard of Care Melphalan0.13± 0.45
Day 3
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.08± 0.41
Day 4
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.04± 0.20
Change in Esophageal Pain as Assessed Per CTCAE v5.0 Secondary · From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

Grade 0 esophageal pain is defined as no esophageal pain. Grade 1 esophageal pain is defined as mild pain. Grade 2 esophageal pain is defined as moderate pain; limiting instrumental ADL. Grade 3 esophageal pain is defined as severe pain; limiting self care ADL. There is no grade 4 or 5 esophageal pain defined in the CTCAE v5.0.

Day -3
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day -2
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day -1
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day 0
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.04± 0.20
Day 1
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.04± 0.20
Day 2
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.12± 0.33
Placebo + Standard of Care Melphalan0.04± 0.20
Day 3
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.04± 0.20
Placebo + Standard of Care Melphalan0.04± 0.20
Day 4
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.08± 0.27
Placebo + Standard of Care Melphalan0.13± 0.34
Change in Abdominal Pain as Assessed Per CTCAE v5.0 Secondary · From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

Grade 0 abdominal pain is defined as no abdominal pain. Grade 1 abdominal pain is defined as mild pain. Grade 2 abdominal pain is defined as moderate pain; limiting instrumental ADL. Grade 3 abdominal pain is defined as severe pain; limiting self care ADL. There is no grade 4 or 5 abdominal pain defined in the CTCAE v5.0.

Day -3
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.04± 0.20
Day -2
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day -1
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.04± 0.20
Day 0
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.16± 0.37
Placebo + Standard of Care Melphalan0.04± 0.20
Day 1
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.19± 0.40
Placebo + Standard of Care Melphalan0.17± 0.38
Day 2
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.35± 0.56
Placebo + Standard of Care Melphalan0.25± 0.44
Day 3
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.12± 0.33
Placebo + Standard of Care Melphalan0.13± 0.34
Day 4
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.12± 0.33
Placebo + Standard of Care Melphalan0.25± 0.61
Change in Nausea as Assessed Per CTCAE v5.0 Secondary · From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

Grade 0 nausea is defined as no nausea. Grade 1 nausea is defined as loss of appetite without alteration in eating habits. Grade 2 nausea is defined as oral intake decreased without significant weight loss, dehydration or malnutrition. Grade 3 nausea is defined as inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated. There is no grade 4 or 5 nausea defined in the CTCAE v5.0.

Day -3
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.08± 0.28
Day -2
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.08± 0.28
Day -1
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.12± 0.33
Placebo + Standard of Care Melphalan0.21± 0.51
Day 0
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.35± 0.63
Placebo + Standard of Care Melphalan0.42± 0.72
Day 1
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.62± 0.75
Placebo + Standard of Care Melphalan0.63± 0.82
Day 2
GroupValue95% CI
Uproleselan + Standard of Care Melphalan1.04± 0.82
Placebo + Standard of Care Melphalan1.13± 0.95
Day 3
GroupValue95% CI
Uproleselan + Standard of Care Melphalan1.00± 0.80
Placebo + Standard of Care Melphalan0.92± 0.88
Day 4
GroupValue95% CI
Uproleselan + Standard of Care Melphalan1.00± 0.80
Placebo + Standard of Care Melphalan1.17± 0.82
Change in Vomiting as Assessed Per CTCAE v5.0 Secondary · From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

Grade 0 vomiting is defined as no vomiting. Grade 1 vomiting is defined as intervention not indicated. Grade 2 vomiting is defined as outpatient IV hydration; medical intervention indicated. Grade 3 vomiting is defined as tube feeding, TPN, or hospitalization indicated. Grade 4 vomiting is defined as life-threatening consequences. Grade 5 vomiting is defined as death.

Day -3
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day -2
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day -1
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.04± 0.20
Placebo + Standard of Care Melphalan0.08± 0.41
Day 0
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.12± 0.43
Placebo + Standard of Care Melphalan0.29± 0.62
Day 1
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.27± 0.60
Placebo + Standard of Care Melphalan0.29± 0.62
Day 2
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.35± 0.69
Placebo + Standard of Care Melphalan0.63± 0.82
Day 3
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.15± 0.46
Placebo + Standard of Care Melphalan0.50± 0.83
Day 4
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.15± 0.46
Placebo + Standard of Care Melphalan0.67± 0.92
Change in Enterocolitis as Assessed Per CTCAE v5.0 Secondary · From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

Grade 0 enterocolitis is defined as no enterocolitis. Grade 1 enterocolitis is defined as asymptomatic; clinical or diagnostic observations only; intervention not indicated. Grade 2 enterocolitis is defined as abdominal pain; mucus or blood in stool. Grade 3 enterocolitis is defined as severe or persistent abdominal pain; fever; ileus; peritoneal signs. Grade 4 enterocolitis is defined as life-threatening consequences; urgent intervention indicated. Grade 5 enterocolitis is defined as death.

Day -3
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day -2
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day -1
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day 0
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day 1
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.08± 0.27
Placebo + Standard of Care Melphalan0.04± 0.20
Day 2
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.04± 0.20
Placebo + Standard of Care Melphalan0.08± 0.41
Day 3
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day 4
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.04± 0.20
Placebo + Standard of Care Melphalan0.04± 0.20
Change in Proctitis as Assessed Per CTCAE v5.0 Secondary · From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

Grade 0 proctitis is defined as no proctitis. Grade 1 proctitis is defined as rectal discomfort, intervention not indicated. Grade 2 proctitis is defined as symptomatic (e.g., rectal discomfort, passing blood or mucus); medical intervention indicated; limiting instrumental ADL. Grade 3 proctitis is defined as severe symptoms; fecal urgency or stool incontinence; limiting self-care ADL. Grade 4 proctitis is defined as life-threatening consequences; urgent intervention indicated. Grade 5 proctitis is defined as death.

Day -3
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day -2
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day -1
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day 0
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day 1
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day 2
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.04± 0.20
Placebo + Standard of Care Melphalan0.00± 0.00
Day 3
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day 4
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.04± 0.20
Change in Hemorrhoids as Assessed Per CTCAE v5.0 Secondary · From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)

Grade 0 hemorrhoids is defined as no hemorrhoids. Grade 1 hemorrhoids is defined as asymptomatic; clinical or diagnostic observations only; intervention not indicated. Grade 2 hemorrhoids is defined as symptomatic; banding or medical intervention indicated. Grade 3 hemorrhoids is defined as severe symptoms; invasive intervention indicated. There is no grade 4 or 5 hemorrhoids defined in the CTCAE v5.0.

Day -3
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day -2
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day -1
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.00± 0.00
Placebo + Standard of Care Melphalan0.00± 0.00
Day 0
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.04± 0.20
Placebo + Standard of Care Melphalan0.00± 0.00
Day 1
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.04± 0.20
Placebo + Standard of Care Melphalan0.00± 0.00
Day 2
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.08± 0.27
Placebo + Standard of Care Melphalan0.00± 0.00
Day 3
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.08± 0.39
Placebo + Standard of Care Melphalan0.00± 0.00
Day 4
GroupValue95% CI
Uproleselan + Standard of Care Melphalan0.12± 0.43
Placebo + Standard of Care Melphalan0.04± 0.20
Time to Neutrophil Engraftment Secondary · Through date of discharge (up to be 18 days)

-Defined as ANC ≥0.5 x 10\^9/L for 3 consecutive days or ≥1.0 x 10\^9/L for 1 day

GroupValue95% CI
Uproleselan + Standard of Care Melphalan12.77± 0.76
Placebo + Standard of Care Melphalan12.50± 0.98

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from first dose of study treatment through D+30 post autologous hematopoietic cell transplant (auto-HCT). The median follow-up time was 47 days (full range 1-58 days). All-cause mortality was collected from start of treatment through study completion. The median follow-up time was 242 days (full range 1-536 days).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Uproleselan + Standard of Care Melphalan
Serious: 5/26 (19%)
Deaths: 2/26
Placebo + Standard of Care Melphalan
Serious: 5/25 (20%)
Deaths: 3/25

Serious adverse events (7 terms)

ReactionSystemUproleselan + Standard of …Placebo + Standard of Care…
FeverGeneral disorders——
NauseaGastrointestinal disorders——
SinusitisInfections and infestations——
BacteremiaInfections and infestations——
Lung InfectionInfections and infestations——
Skin InfectionInfections and infestations——
SepsisInfections and infestations——
Other adverse events (136 terms — click to expand)

ReactionSystemUproleselan + Standard of …Placebo + Standard of Care…
DiarrheaGastrointestinal disorders——
Neutrophil count decreasedInvestigations——
Platelet count decreasedInvestigations——
White blood cell decreasedInvestigations——
HypocalcemiaMetabolism and nutrition disorders——
AnemiaBlood and lymphatic system disorders——
NauseaGastrointestinal disorders——
Lymphocyte count decreasedInvestigations——
FatigueGeneral disorders——
HypoalbuminemiaMetabolism and nutrition disorders——
Abdominal PainGastrointestinal disorders——
INR increasedInvestigations——
HypophosphatemiaMetabolism and nutrition disorders——
VomitingGastrointestinal disorders——
HypokalemiaMetabolism and nutrition disorders——
Esophageal PainGastrointestinal disorders——
Mucositis oralGastrointestinal disorders——
FeverGeneral disorders——
EsophagitisGastrointestinal disorders——
ConstipationGastrointestinal disorders——
EnterocolitisGastrointestinal disorders——
MalaiseGeneral disorders——
AnorexiaMetabolism and nutrition disorders——
HyponatremiaMetabolism and nutrition disorders——
HypotensionVascular disorders——
ThrushInfections and infestations——
GastritisGastrointestinal disorders——
HypernatremiaMetabolism and nutrition disorders——
DizzinessNervous system disorders——
HeadacheNervous system disorders——
HemorrhoidsGastrointestinal disorders——
Edema LimbsGeneral disorders——
HyperglycemiaMetabolism and nutrition disorders——
Back PainMusculoskeletal and connective tissue disorders——
DysuriaRenal and urinary disorders——
Febrile neutropeniaBlood and lymphatic system disorders——
ProctitisGastrointestinal disorders——
Alanine aminotransferase increasedInvestigations——
HypermagnesemiaMetabolism and nutrition disorders——
Peripheral Sensory NeuropathyNervous system disorders——

Most-reported serious reactions: Fever, Nausea, Sinusitis, Bacteremia, Lung Infection, Skin Infection, Sepsis.

Data from ClinicalTrials.gov NCT04682405 adverse events section.

Sponsor's own description

The investigators hypothesize that prophylactic E-selectin inhibition via administration of uproleselan during melphalan conditioning will reduce the gastrointestinal (GI) toxicity in multiple myeloma (MM) patients undergoing auto-transplant, as assessed via diarrhea severity scoring per CTCAE v5.0, while potentially increasing chemosensitivity of malignant MM cells to high-dose melphalan.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. P- and E- selectin in venous thrombosis and non-venous pathologies.
    Purdy M, Obi A, Myers D, Wakefield T. · · 2022 · cited 60× · PMID 35243742 · DOI 10.1111/jth.15689
  2. Glycan-Lectin Interactions in Cancer and Viral Infections and How to Disrupt Them.
    Kremsreiter SM, Kroell AH, Weinberger K, Boehm H. · · 2021 · cited 33× · PMID 34638920 · DOI 10.3390/ijms221910577
  3. Biological and Clinical Aspects of Metastatic Spinal Tumors.
    Litak J, Czyżewski W, Szymoniuk M, Sakwa L, et al · · 2022 · cited 17× · PMID 36230523 · DOI 10.3390/cancers14194599
  4. Targeting hematologic malignancies by inhibiting E-selectin: A sweet spot for AML therapy?
    Uy GL, DeAngelo DJ, Lozier JN, Fisher DM, et al · · 2024 · cited 7× · PMID 38493006 · DOI 10.1016/j.blre.2024.101184
  5. A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate E-Selectin Inhibition with Uproleselan to Reduce Gastrointestinal Toxicity During Autologous Hematopoietic Cell Transplantation for Multiple Myeloma.
    Crees ZD, Stockerl-Goldstein K, Ryan M, Gao F, et al · · 2026 · PMID 41218716 · DOI 10.1016/j.jtct.2025.11.007

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Trials by the same sponsor.

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