Multiple MyelomaPhase 2NCT04682405
Uproleselan (GMI-1271) for GI Toxicity Prophylaxis During Melphalan-Conditioned Autologous Hematopoietic Cell Transplantation (Auto-HCT) for Multiple Myeloma (MM)
A Phase 2 study testing Uproleselan and Melphalan in people with Multiple Myeloma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Uproleselan and Melphalan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2021to 11 Nov 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-confirmed multiple myeloma (MM) (per IMWG criteria).
- Undergoing first auto-HCT for MM in first partial response (PR) or better
- Conditioning regimen to be single agent melphalan (200 mg/m^2)
- Adults 18 to 75 years of age, inclusive
- ECOG performance status ≤ 2
- Mobilized ≥ 5.0 x 10^6 CD34+ cells/kg (i.e. sufficient CD34+ HSCs for one auto-HCT, with at least one back-up graft in reserve)
Show all 14Show fewer
- Adequate bone marrow and organ function prior to stem cell mobilization as defined below:
- Leukocytes, absolute neutrophil count, and platelets within institutional standard limits for high-dose melphalan autologous stem cell transplant
- Total bilirubin ≤ 1.5 x ULN (unless the patient has a history of Gilbert's Syndrome, in which case, total bilirubin must be ≤ 2.5 times the ULN)
- AST(SGOT)/ALT(SGPT) ≤ 3.0 x ULN
- Creatinine clearance ≥ 30 mL/min by Cockcroft-Gault
- Baseline pulmonary function test (PFT) with carbon monoxide diffusion capacity in the lung (DLCO) ≥ 50% and forced expiratory volume in 1 second (FEV1) both within institutional standard limits for high-dose melphalan autologous stem cell transplant
- The effects of uproleselan (GMI-1271) on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, prior sterilization procedure, abstinence, etc.) prior to study entry, for the duration of study participation and for 12 weeks after the completion of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Should a man who is participating in the study become aware that he has impregnated a partner, he must inform his treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Who cannot join
- A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.
- Active signs or symptoms of CNS involvement by malignancy (lumbar puncture not required). Prior history of CNS involvement is acceptable, if patient has completed treatment for CNS involvement with documented treatment response.
- Prior exposure to uproleselan (GMI-1271)
- Currently receiving any other investigational agents
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to uproleselan or melphalan
- Known active infection with hepatitis A, B (e.g., HBsAg positive), or C (e.g., anti-HCV positive), or human immunodeficiency virus
Show all 18Show fewer
- Uncontrolled acute life-threatening bacterial, viral, or fungal infection-Myocardial infarction within 6 months of uproleselan/placebo dosing, or subject has current significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, hemodynamic instability, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
- Any medical, psychiatric, or other condition which, in the opinion of the investigator, unfavorably alters the risk-benefit of subject participation, is likely to interfere with trial completion, assessments, or interpretation of trial results, or otherwise would make the subject an inappropriate subject for this trial.
- Pregnant and/or breastfeeding.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception during the trial and for 12 weeks following the last dose of uproleselan/placebo. Women who are postmenopausal with amenorrhea for at least 1 year prior to trial entry and follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status (>28U/L) will be considered NOT of childbearing potential. Highly effective contraception includes:
- Total abstinence with a male partner.
- Female sterilization (has had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks before uproleselan/placebo. In case of oophorectomy alone, the subject would be eligible only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
- Male sterilization (at least 6 months prior to Screening). For female subjects on the trial, the vasectomized male partner should be the sole partner for that subject.
- BOTH of the following forms of contraception consistently used together:
- Injected, transdermal, or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%) with the exception of intrauterine devices, which are excluded due to the risk of infection and bleeding.
- Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with or without spermicidal foam/gel/film/cream/vaginal suppository.
- Men who are sexually active and not willing to use condoms during the trial and for 12 weeks following the last dose of uproleselan/placebo, unless they have undergone vasectomy for sterilization (at least 6 months prior to Screening), are excluded from trial participation.
- Men who are sexually active and not willing to use condoms during the trial and for 12 weeks following the last dose of uproleselan/placebo, unless they have undergone vasectomy for sterilization (at least 6 months prior to Screening), are excluded from trial participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Uproleselan (GMI-1271) for GI Toxicity Prophylaxis During Melphalan-Conditioned Autologous Hematopoietic Cell Transplantation (Auto-HCT) for Multiple Myeloma (MM)
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.
- Conditions
- Multiple Myeloma
- Being tested
- Uproleselan, Placebo, Melphalan
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UproleselanDrug
Also called GM-1271
Provided by study
PlaceboDrug
Provided by study
MelphalanDrug
-Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Uproleselan + Standard of Care Melphalan | Experimental | * On the evening of Day -3, patients will receive dose #1 of uproleselan
* On the following morning of Day -2 (12 +/- 2 hours from prior dose), patients will receive dose #2 of uproleselan
* On the evening of Day -2 (12 +/- 2 hours from prior dose), patients will receive dose #3 of uproleselan
* On Day -2 following completion of dose #3 of uproleselan, the patient will be administered the conditioning dose of melphalan (200mg/m^2) as per institutional practice.
* On the following morning of Day -1 (12 +/- 2 hours from prior dose), patients will receive dose #4 of uproleselan
* On the evening of Day -1 (12 +/- 2 hours from prior dose), patients will receive dose #5 of uproleselan
* On the following morning of Day 0 (12 +/- 2 hours from prior dose) patients will receive dose #6 (final dose) of uproleselan
* On Day 0, 4 hours (+/- 2 hours) after the final dose of uproleselan, the patient will be infused with the HSC product. The patient will remain inpatient until engraftment Receives: Drug: Uproleselan; Drug: Melphalan |
| Placebo + Standard of Care Melphalan | Placebo comparator | * On the evening of Day -3, patients will receive dose #1 of placebo
* On the following morning of Day -2 (12 +/- 2 hours from prior dose), patients will receive dose #2 of placebo On the evening of Day -2 (12 +/- 2 hours from prior dose), patients will receive dose #3 of placebo.
* On Day -2 following completion of dose #3 of placebo, the patient will be administered the conditioning dose of melphalan (200mg/m^2) as per institutional practice.
* On the following morning of Day -1 (12 +/- 2 hours from prior dose), patients will receive dose #4 of placebo.
* On the evening of Day -1 (12 +/- 2 hours from prior dose), patients will receive dose #5 of placebo.
* On the following morning of Day 0 (12 +/- 2 hours from prior dose) patients will receive dose #6 (final dose) of placebo.
* On Day 0, 4 hours (+/- 2 hours) after the final dose of placebo, the patient will be infused with the HSC product. The patient will remain inpatient until engraftment Receives: Drug: Placebo; Drug: Melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Diarrhea as Assessed Per CTCAE v5.0
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 indicated. Grade 5 is defined as death.
Measured: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
Secondary outcomes (23)
Change in Oral Mucositis as Assessed Per CTCAE v5.0
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.
Measured: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
Change in Esophagitis as Assessed Per CTCAE v5.0
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.
Measured: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
Change in Gastritis as Assessed Per CTCAE v5.0
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.
Measured: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
Change in Esophageal Pain as Assessed Per CTCAE v5.0
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.
Measured: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
Change in Abdominal Pain as Assessed Per CTCAE v5.0
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.
Measured: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
Change in Nausea as Assessed Per CTCAE v5.0
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.
Measured: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
Change in Vomiting as Assessed Per CTCAE v5.0
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.
Measured: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
Change in Enterocolitis as Assessed Per CTCAE v5.0
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.
Measured: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
Change in Proctitis as Assessed Per CTCAE v5.0
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.
Measured: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
Change in Hemorrhoids as Assessed Per CTCAE v5.0
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.
Measured: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
Time to Neutrophil Engraftment
-Defined as ANC ≥0.5 x 10^9/L for 3 consecutive days or ≥1.0 x 10^9/L for 1 day
Measured: Through date of discharge (up to be 18 days)
Change in Nutritional Status as Assessed by Total Parenteral Nutrition (TPN) Days
Measured: Before conditioning and at day +14 or date of discharge (whichever is sooner) (up to be 18 days)
Duration of Hospital Length of Stay
Measured: From date of admission for auto-HCT to date of discharge (up to be 18 days)
Change in Bristol Stool Scale
Change in Bristol Stool Scale as measured by incidence of Type 7 Bristol Stool Scale: liquid consistency with no solid pieces.
Measured: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
Change in Nutritional Status as Assessed by Change in Standing Weight
Patient standing weight in kilograms was taken at specific time points to assess any changes in nutritional status.
Measured: Day -3, Day 8, and date of discharge or Day 14 (whichever is sooner) (up to be 18 days)
Incidence of Infection Assessed by Rates of Bacteremia (With Organism Reported When Available)
Measured: Through date of discharge (upto be 18 days)
Time to First Antibiotics
Measured by the time in days to the first antibiotic dose for bacteremia.
Measured: Through date of discharge (up to be day 18)
Incidence of Clostridium Difficile Infections
Measured: Through date of discharge (up to be 18 days)
Median Daily Dose of Anti-diarrheal Medications
This is defined as the number of doses of anti-diarrheal medications, such as loperamide or lomotil, that participants took daily.
Measured: Through date of discharge (up to be 18 days)
Median Daily Dose of Pain Medications
The median daily dose of pain medications is provided as morphine equivalents.
Measured: Through date of discharge (up to be 18 days)
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0
- Questions regarding gastrointestinal toxicities
- Responses are scored from 1-5 with 1=no symptoms to 5=severe symptoms
Measured: Day -3, Day +8, date of discharge or Day +14 (whichever is sooner) (up to 18 days)
Median Change in Scores of Quality of Life as Measured by the CTCAE Pro Form v 1.0
- Questions regarding gastrointestinal, pain, and psychological symptoms interfering with daily activities
- Responses are scored from 1-5 with 1=not at all to 5=very much
Measured: Day -3, Day +8, date of discharge or Day +14 (whichever is sooner) (up to 18 days)
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0
- Questions regarding gastrointestinal toxicities
- Responses are scored from 1-5 with 1=never and 5=almost constantly
Measured: Day -3, Day +8, date of discharge or Day +14 (whichever is sooner) (up to 18 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start5 May 2021
- Primary completion11 Nov 2022
- Study completion11 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- GlycoMimetics Incorporated, The Foundation for Barnes-Jewish Hospital
- Responsible party
- Sponsor
- Investigators
- Keith Stockerl-Goldstein, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682405
- Sponsor's protocol ID
- 202103086
- Status last verified
- Dec 2023
- First submitted
- 18 Dec 2020
- Last updated
- 15 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Uproleselan (GMI-1271) for GI Toxicity Prophylaxis During Melphalan-Conditioned Autologous Hematopoietic Cell Transplantation (Auto-HCT) for Multiple Myeloma (MM)
- ClinicalTrials.gov ID
- NCT04682405
- Acronym / sponsor ID
- 202103086
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- GlycoMimetics Incorporated, The Foundation for Barnes-Jewish Hospital
- Study start
- 5 May 2021 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Posted 15 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uproleselan + Standard of Care Melphalan | Experimental | Drug: Uproleselan, Drug: Melphalan* On the evening of Day -3, patients will receive dose #1 of uproleselan * On the following morning of Day -2 (12 +/- 2 hours from prior dose), patients will receive dose #2 of uproleselan * On the evening of Day -2 (12 +/- 2 hours from prior dose), patients will receive dose #3 of uproleselan * On Day -2 following completion of dose #3 of uproleselan, the patient will be administered the conditioning dose of melphalan (200mg/m^2) as per institutional practice. * On the following morning of Day -1 (12 +/- 2 hours from prior dose), patients will receive dose #4 of uproleselan * On the evening of Day -1 (12 +/- 2 hours from prior dose), patients will receive dose #5 of uproleselan * On the following morning of Day 0 (12 +/- 2 hours from prior dose) patients will receive dose #6 (final dose) of uproleselan * On Day 0, 4 hours (+/- 2 hours) after the final dose of uproleselan, the patient will be infused with the HSC product. The patient will remain inpatient until engraftment |
| Placebo + Standard of Care Melphalan | Placebo comparator | Drug: Placebo, Drug: Melphalan* On the evening of Day -3, patients will receive dose #1 of placebo * On the following morning of Day -2 (12 +/- 2 hours from prior dose), patients will receive dose #2 of placebo On the evening of Day -2 (12 +/- 2 hours from prior dose), patients will receive dose #3 of placebo. * On Day -2 following completion of dose #3 of placebo, the patient will be administered the conditioning dose of melphalan (200mg/m^2) as per institutional practice. * On the following morning of Day -1 (12 +/- 2 hours from prior dose), patients will receive dose #4 of placebo. * On the evening of Day -1 (12 +/- 2 hours from prior dose), patients will receive dose #5 of placebo. * On the following morning of Day 0 (12 +/- 2 hours from prior dose) patients will receive dose #6 (final dose) of placebo. * On Day 0, 4 hours (+/- 2 hours) after the final dose of placebo, the patient will be infused with the HSC product. The patient will remain inpatient until engraftment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Biopsy-confirmed multiple myeloma (MM) (per IMWG criteria).
- Undergoing first auto-HCT for MM in first partial response (PR) or better
- Conditioning regimen to be single agent melphalan (200 mg/m^2)
- Adults 18 to 75 years of age, inclusive
- ECOG performance status ≤ 2
Key exclusion criteria (18 listed)
- A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.
- Active signs or symptoms of CNS involvement by malignancy (lumbar puncture not required). Prior history of CNS involvement is acceptable, if patient has completed treatment for CNS involvement with documented treatment response.
- Prior exposure to uproleselan (GMI-1271)
- Currently receiving any other investigational agents
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to uproleselan or melphalan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UproleselanAlso: GM-1271Provided by study | Drug | Uproleselan + Standard of Care Melphalan |
| PlaceboProvided by study | Drug | Placebo + Standard of Care Melphalan |
| Melphalan-Standard of care | Drug | Placebo + Standard of Care Melphalan, Uproleselan + Standard of Care Melphalan |
Primary outcome
Change in Diarrhea as Assessed Per CTCAE v5.0
Time frame: 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 indicated. Grade 5 is defined as death.
23 secondary outcomes
Change in Oral Mucositis as Assessed Per CTCAE v5.0
Time frame: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
Change in Esophagitis as Assessed Per CTCAE v5.0
Time frame: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
Change in Gastritis as Assessed Per CTCAE v5.0
Time frame: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
Change in Esophageal Pain as Assessed Per CTCAE v5.0
Time frame: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
Change in Abdominal Pain as Assessed Per CTCAE v5.0
Time frame: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
Change in Nausea as Assessed Per CTCAE v5.0
Time frame: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
Change in Vomiting as Assessed Per CTCAE v5.0
Time frame: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
Change in Enterocolitis as Assessed Per CTCAE v5.0
Time frame: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
Change in Proctitis as Assessed Per CTCAE v5.0
Time frame: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
Change in Hemorrhoids as Assessed Per CTCAE v5.0
Time frame: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
Time to Neutrophil Engraftment
Time frame: Through date of discharge (up to be 18 days)
Change in Nutritional Status as Assessed by Total Parenteral Nutrition (TPN) Days
Time frame: Before conditioning and at day +14 or date of discharge (whichever is sooner) (up to be 18 days)
Duration of Hospital Length of Stay
Time frame: From date of admission for auto-HCT to date of discharge (up to be 18 days)
Change in Bristol Stool Scale
Time frame: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)
Change in Nutritional Status as Assessed by Change in Standing Weight
Time frame: Day -3, Day 8, and date of discharge or Day 14 (whichever is sooner) (up to be 18 days)
Incidence of Infection Assessed by Rates of Bacteremia (With Organism Reported When Available)
Time frame: Through date of discharge (upto be 18 days)
Time to First Antibiotics
Time frame: Through date of discharge (up to be day 18)
Incidence of Clostridium Difficile Infections
Time frame: Through date of discharge (up to be 18 days)
Median Daily Dose of Anti-diarrheal Medications
Time frame: Through date of discharge (up to be 18 days)
Median Daily Dose of Pain Medications
Time frame: Through date of discharge (up to be 18 days)
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0
Time frame: Day -3, Day +8, date of discharge or Day +14 (whichever is sooner) (up to 18 days)
Median Change in Scores of Quality of Life as Measured by the CTCAE Pro Form v 1.0
Time frame: Day -3, Day +8, date of discharge or Day +14 (whichever is sooner) (up to 18 days)
Median Change in Scores of Patient Reported Outcomes as Measured by the CTCAE Pro Form v1.0
Time frame: Day -3, Day +8, date of discharge or Day +14 (whichever is sooner) (up to 18 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Stockerl-Goldstein, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Uproleselan and Melphalan in people with Multiple Myeloma, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diarrhea as Assessed Per CTCAE v5.0 (time frame: From day -3 to date of discharge or day 14 (whichever is sooner) (up to be 18 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.