Multiple MyelomaPhase 4NCT07101445
Evaluating Premedication Regimens (Methylprednisolone vs Dexamethasone-based) for the Prevention of Systemic and Injection Site Reactions to Motixafortide in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization, PARADE Trial
A Phase 4 study testing Acetaminophen, Biospecimen Collection and Dexamethasone in people with Multiple Myeloma, run by Emory University at 1 site in United States.
Trial summary
This phase IV trial compares the effect of premedication regimens with methylprednisolone versus dexamethasone for the prevention of allergic reaction to motixafortide in patients with multiple myeloma (MM) undergoing stem cell mobilization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Acetaminophen, Biospecimen Collection and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2025to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be aged 18 years or older.
- Patient must understand and voluntarily signed an informed consent form.
- Patient must be willing and able to adhere to the study schedule and other protocol requirements.
- Histologically confirmed multiple myeloma prior to enrollment and randomization.
- Eligible for hematopoietic stem cell mobilization and autologous hematopoietic stem cell transplantation as per institutional guidelines.
- Females of reproductive potential must use effective contraception during treatment with motixafortide and for 8 days after the final dose.
Who cannot join
- Previous history of autologous or allogeneic hematopoietic cell transplantation.
- History of hemoglobin SS disease or hemoglobin S trait precluding the patient's ability to use G-CSF.
- History of steroid-induced psychosis or encephalopathy requiring medical intervention.
- History of type I or II diabetes mellitus that is poorly controlled or with high glucose variability precluding safe administration of dexamethasone 12mg IV as premedication in the opinion of the investigator.
- History of serious systemic reaction to motixafortide.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Joseph Rimando, MD, 404-778-8696, jrimand@emory.edu
Joseph Rimando, MD
About this study
Official title: Prevent Allergic Reactions to Aphexda With Dexamethasone (PARADE)
This phase IV trial compares the effect of premedication regimens with methylprednisolone versus dexamethasone for the prevention of allergic reaction to motixafortide in patients with multiple myeloma (MM) undergoing stem cell mobilization. MM patients that receive an autologous stem cell transplantation (ASCT) have better outcomes. However, not all MM patients are able to have a successful stem cell mobilization and collection which is needed to proceed to ASCT. The addition of motixafortide prior to stem cell mobilization has allowed more MM patients to collect the needed number of stem cells to proceed to ASCT. However, motixafortide does produce systemic and injection site reactions in many patients. The optimal medication regimen to prevent reactions remains unknown. A premedication regimen with dexamethasone prior to motixafortide decreases the incidence of reactions in many patients and is considered the standard of care regimen for the prevention of systemic and injection site reactions to motixafortide in patients with MM undergoing stem cell mobilization. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen side effects/allergic reactions. However, dexamethasone is associated with other side effects like headache, difficulty sleeping, high blood glucose, high blood pressure, mood changes, fluid retention, and infection, among others. A premedication regimen with methylprednisolone prior to motixafortide may work better to decrease the incidence of reactions to motixafortide in patients with MM undergoing stem cell mobilization. Methylprednisolone is in a class of medications called corticosteroids. It works to decrease side effects/allergic reactions by changing the way the immune system works. Giving methylprednisolone may be safe, tolerable and/or more effective than dexamethasone as part of a premedication regimen for the prevention of allergic reaction to motixafortide in patients with MM undergoing stem cell mobilization.
Read the detailed description
PRIMARY OBJECTIVE:
- Evaluate the safety and efficacy of a premedication regimen for motixafortide that includes loratadine, famotidine, acetaminophen, montelukast, and dexamethasone 12mg intravenously (IV) with an experimental regimen that replaces dexamethasone with methylprednisolone 125mg IV.
SECONDARY OBJECTIVES:
- Compare the tolerability and patient experience between the regimens. II. Compare the effects of the two regimens on stem cell mobilization. III. Explore the potential immunomodulatory effects of the two regimens.
EXPLORATORY OBJECTIVE:
- Assess the anti-myeloma activity of motixafortide.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive granulocyte colony-stimulating factor (G-CSF) once daily (QD) in the morning and loratadine orally (PO) twice daily (BID) on days 1 - 3. Patients receive G-CSF and loratadine PO once in the morning on day 4. Patients then receive loratadine PO, famotidine PO, acetaminophen PO, montelukast PO and dexamethasone IV once in the afternoon on day 4 and 1 hour later receive motixafortide subcutaneously (SC) once in the afternoon on day 4. Patients receive G-CSF once in the morning on day 5 and undergo stem cell apheresis in the morning on day 5. Patients may undergo additional stem cell apheresis on days 6, 7 and/or 8 if target dose of CD34+ cells is not achieved on day 5. Patients may receive additional G-CSF QD in the morning and loratadine PO BID on days 6, 7 and/or 8 if the target dose of CD34+ cells is not achieved on day 5. Patients undergoing additional stem cell apheresis on days 7 and 8 receive loratadine PO, famotidine PO, acetaminophen PO, montelukast PO and dexamethasone IV once in the afternoon on day 6 and 1 hour later receive motixafortide SC once in the afternoon on day 6. Treatment continues in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive G-CSF QD in the morning and loratadine PO BID on days 1 - 3. Patients receive G-CSF and loratadine PO once in the morning on day 4. Patients then receive loratadine PO, famotidine PO, acetaminophen PO, montelukast PO and methylprednisolone IV once in the afternoon on day 4 and 1 hour later receive motixafortide SC once in the afternoon on day 4. Patients receive G-CSF once in the morning on day 5 and undergo stem cell apheresis in the morning on day 5. Patients may undergo additional stem cell apheresis on days 6, 7 and/or 8 if target dose of CD34+ cells is not achieved on day 5. Patients may receive additional G-CSF QD in the morning and loratadine PO BID on days 6, 7 and/or 8 if the target dose of CD34+ cells is not achieved on day 5. Patients undergoing additional stem cell apheresis on days 7 and 8 receive loratadine PO, famotidine PO, acetaminophen PO, montelukast PO and dexamethasone IV once in the afternoon on day 6 and 1 hour later receive motixafortide SC once in the afternoon on day 6. Treatment continues in the absence of disease progression or unacceptable toxicity.
Additionally, patients undergo blood sample collection on study.
- Conditions
- Multiple Myeloma
- Being tested
- Acetaminophen, Biospecimen Collection, Dexamethasone, Electronic Health Record Review, Famotidine
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Acetaminophen (APAP), Paracetamol, Tylenol
Given by mouth (PO).
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
DexamethasoneDrug
Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex
Given intravenously (IV).
Electronic Health Record ReviewOther
Ancillary studies
FamotidineDrug
Also called Pepcid, Pepcid AC
Given by mouth (PO).
LoratadineDrug
Also called Claritin
Given by mouth (PO).
Also called Adlone, Caberdelta M, DepMedalone, Depo Moderin
Given intravenously (IV).
MontelukastDrug
Given by mouth (PO).
MotixafortideDrug
Also called 4F-Benzoyl-TN14003, BKT 140, BKT-140, BKT140
Given subcutaneously (SC).
PheresisProcedure or surgery
Also called Apheresed, Apheresis, Blood Component Removal, Collection, Apheresis/Leukapheresis
Undergo apheresis
Questionnaire AdministrationOther
Ancillary studies
Recombinant Granulocyte Colony-Stimulating FactorBiological
Also called Recombinant Colony-Stimulating Factor 3, rhG-CSF
Give Granulocyte Colony-Stimulating Factor (G-CSF).
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Dexamethasone) | Active comparator | See Detailed Description Receives: Drug: Acetaminophen; Procedure: Biospecimen Collection; Drug: Dexamethasone; Other: Electronic Health Record Review; Drug: Famotidine; Drug: Loratadine; Drug: Montelukast; Drug: Motixafortide; Procedure: Pheresis; Other: Questionnaire Administration; Biological: Recombinant Granulocyte Colony-Stimulating Factor |
| Arm II (Methylprednisolone) | Experimental | See Detailed Description Receives: Drug: Acetaminophen; Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Drug: Famotidine; Drug: Loratadine; Drug: Methylprednisolone; Drug: Montelukast; Drug: Motixafortide; Procedure: Pheresis; Other: Questionnaire Administration; Biological: Recombinant Granulocyte Colony-Stimulating Factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of systemic reactions
Will compare the incidence and severity of systemic reactions after administration of motixafortide. Systemic reactions will be graded as per Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Analysis will be based upon an intent-to-treat analysis of all subjects who are randomized to receive dexamethasone or methylprednisolone. Will evaluate the proportion of patients who develop systemic reactions stratified by grade associated with motixafortide between the two premedication regimens. The non-inferiority probability (p)-value between the two arms will be carried out using one-sided z-test. In addition, these two groups will be compared at patient level using chi-square test or Fisher's Exact test. A logistic regression will be used to estimate the odd ratio between the two arms controlling for the baseline covariates for an improved precision of the estimation.
Measured: At day 4 and 5
Incidence and severity of injection site reactions
Will compare the incidence and severity of injection site reactions after administration of motixafortide. Injection site reactions will be graded as per CTCAE v5.0. The incidence of injection site reactions after administration of motixafortide between the two premedication regimens will be similarly compared to that of the incidence and severity of systemic reactions.
Measured: At day 4 and 5
Secondary outcomes (4)
Compare Tolerability Between Regimens
Will compare the change in patient-reported outcomes (PROs) on tolerability before and after administration of the two premedication regimens. Domains will include fatigue, sleep-related disturbances, sleep-related impairment, cognitive function, global functioning, pruritus, and urticaria. Evaluable subjects will be all subjects who were randomized to receive dexamethasone or methylprednisolone. For the (PRO) on tolerability before and after administration of the two premedication regimens, the difference in the mean scores along with the standard deviations for each individual scale (sleep, allergy, injection site reactions and fatigue/function) will be descriptively reported. Internal consistency reliability by Crocbach's alpha for each scale per treatment arm will be evaluated using Crocbach's alpha. Never=1, Rarely=2, Sometimes=3, Often=4, Always=5. Injection Site Reactions Scale: Not at all=1, A little bit=2, Somewhat=3, Quite a bit=4, Very much=5.
Measured: At days 4 and 5
CD34+ hematopoietic stem and progenitor cells (HSPC)/kg collection
Will compare the median number of CD34+ HSPC/kg collected. Evaluable subjects will be all subjects who were randomized to receive dexamethasone or methylprednisolone. Median number of CD34+ HSPC/kg collected will be compared between the two arms using a Wilcoxon rank-sum test and their respective interquartile ranges will be reported.
Measured: Up to day 8
Collection of >= 6 x 10^6 CD34+ HSPC/kg
Will compare the number of patients collecting >= 6 x 10^6 CD34+ HSPC/kg within one apheresis procedure. Evaluable subjects will be all subjects who were randomized to receive dexamethasone or methylprednisolone. Comparison between number of patients collecting >= 6 x 10^6 CD34+ HSPC/kg in one apheresis procedure for the two arms will be conducted using the t-test or the Wilcoxon rank-sum test as appropriate.
Measured: At day 5
Cytokine levels
Will compare the change in plasma cytokine levels before and after administration of the two premedication regimens. Plasma samples for cytokine analysis will be drawn on day 4 prior to premedication administration and then on day 5 prior to apheresis. Cytokine levels will be analyzed by the Winship Cancer Institute core cytokine analysis facilities using multiplex technology. These analyses will focus on Th2 cytokines and mast cell degranulation. Evaluable subjects will be all subjects who were randomized to receive dexamethasone or methylprednisolone. The changes in plasma cytokine levels before and after administration of the two premedication regimens will be descriptively analyzed using means with standard deviations or median with ranges as appropriate.
Measured: At days 4 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start24 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Gamida Cell ltd
- Responsible party
- Principal investigator, Joseph Cataquiz Rimando, Emory University
- Investigators
- Joseph Rimando, MD, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101445
- Sponsor's protocol ID
- STUDY00008909
- Other IDs
- NCI-2025-03018, STUDY00008909, WINSHIP6478-24, P30CA138292
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevent Allergic Reactions to Aphexda With Dexamethasone (PARADE)
- ClinicalTrials.gov ID
- NCT07101445
- Acronym / sponsor ID
- STUDY00008909
- Conditions
- Multiple Myeloma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Gamida Cell ltd
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase IV trial compares the effect of premedication regimens with methylprednisolone versus dexamethasone for the prevention of allergic reaction to motixafortide in patients with multiple myeloma (MM) undergoing stem cell mobilization. MM patients that receive an autologous stem cell transplantation (ASCT) have better outcomes. However, not all MM patients are able to have a successful stem cell mobilization and collection which is needed to proceed to ASCT. The addition of motixafortide prior to stem cell mobilization has allowed more MM patients to collect the needed number of stem cells to proceed to ASCT. However, motixafortide does produce systemic and injection site reactions in many patients. The optimal medication regimen to prevent reactions remains unknown. A premedication regimen with dexamethasone prior to motixafortide decreases the incidence of reactions in many patients and is considered the standard of care regimen for the prevention of systemic and injection site reactions to motixafortide in patients with MM undergoing stem cell mobilization. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen side effects/allergic reactions. However, dexamethasone is associated with other side effects like headache, difficulty sleeping, high blood glucose, high blood pressure, mood changes, fluid retention, and infection, among others. A premedication regimen with methylprednisolone prior to motixafortide may work better to decrease the incidence of reactions to motixafortide in patients with MM undergoing stem cell mobilization. Methylprednisolone is in a class of medications called corticosteroids. It works to decrease side effects/allergic reactions by changing the way the immune system works. Giving methylprednisolone may be safe, tolerable and/or more effective than dexamethasone as part of a premedication regimen for the prevention of allergic reaction to motixafortide in patients with MM undergoing stem cell mobilization.
Detailed description
PRIMARY OBJECTIVE:
- Evaluate the safety and efficacy of a premedication regimen for motixafortide that includes loratadine, famotidine, acetaminophen, montelukast, and dexamethasone 12mg intravenously (IV) with an experimental regimen that replaces dexamethasone with methylprednisolone 125mg IV.
SECONDARY OBJECTIVES:
- Compare the tolerability and patient experience between the regimens. II. Compare the effects of the two regimens on stem cell mobilization. III. Explore the potential immunomodulatory effects of the two regimens.
EXPLORATORY OBJECTIVE:
- Assess the anti-myeloma activity of motixafortide.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive granulocyte colony-stimulating factor (G-CSF) once daily (QD) in the morning and loratadine orally (PO) twice daily (BID) on days 1 - 3. Patients receive G-CSF and loratadine PO once in the morning on day 4. Patients then receive loratadine PO, famotidine PO, acetaminophen PO, montelukast PO and dexamethasone IV once in the afternoon on day 4 and 1 hour later receive motixafortide subcutaneously (SC) once in the afternoon on day 4. Patients receive G-CSF once in the morning on day 5 and undergo stem cell apheresis in the morning on day 5. Patients may undergo additional stem cell apheresis on days 6, 7 and/or 8 if target dose of CD34+ cells is not achieved on day 5. Patients may receive additional G-CSF QD in the morning and loratadine PO BID on days 6, 7 and/or 8 if the target dose of CD34+ cells is not achieved on day 5. Patients undergoing additional stem cell apheresis on days 7 and 8 receive loratadine PO, famotidine PO, acetaminophen PO, montelukast PO and dexamethasone IV once in the afternoon on day 6 and 1 hour later receive motixafortide SC once in the afternoon on day 6. Treatment continues in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive G-CSF QD in the morning and loratadine PO BID on days 1 - 3. Patients receive G-CSF and loratadine PO once in the morning on day 4. Patients then receive loratadine PO, famotidine PO, acetaminophen PO, montelukast PO and methylprednisolone IV once in the afternoon on day 4 and 1 hour later receive motixafortide SC once in the afternoon on day 4. Patients receive G-CSF once in the morning on day 5 and undergo stem cell apheresis in the morning on day 5. Patients may undergo additional stem cell apheresis on days 6, 7 and/or 8 if target dose of CD34+ cells is not achieved on day 5. Patients may receive additional G-CSF QD in the morning and loratadine PO BID on days 6, 7 and/or 8 if the target dose of CD34+ cells is not achieved on day 5. Patients undergoing additional stem cell apheresis on days 7 and 8 receive loratadine PO, famotidine PO, acetaminophen PO, montelukast PO and dexamethasone IV once in the afternoon on day 6 and 1 hour later receive motixafortide SC once in the afternoon on day 6. Treatment continues in the absence of disease progression or unacceptable toxicity.
Additionally, patients undergo blood sample collection on study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Dexamethasone) | Active comparator | Drug: Acetaminophen, Procedure: Biospecimen Collection, Drug: Dexamethasone, Other: Electronic Health Record Review, Drug: Famotidine, Drug: Loratadine, Drug: Montelukast, Drug: Motixafortide, Procedure: Pheresis, Other: Questionnaire Administration, Biological: Recombinant Granulocyte Colony-Stimulating FactorSee Detailed Description |
| Arm II (Methylprednisolone) | Experimental | Drug: Acetaminophen, Procedure: Biospecimen Collection, Other: Electronic Health Record Review, Drug: Famotidine, Drug: Loratadine, Drug: Methylprednisolone, Drug: Montelukast, Drug: Motixafortide, Procedure: Pheresis, Other: Questionnaire Administration, Biological: Recombinant Granulocyte Colony-Stimulating FactorSee Detailed Description |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must be aged 18 years or older.
- Patient must understand and voluntarily signed an informed consent form.
- Patient must be willing and able to adhere to the study schedule and other protocol requirements.
- Histologically confirmed multiple myeloma prior to enrollment and randomization.
- Eligible for hematopoietic stem cell mobilization and autologous hematopoietic stem cell transplantation as per institutional guidelines.
Key exclusion criteria (5 listed)
- Previous history of autologous or allogeneic hematopoietic cell transplantation.
- History of hemoglobin SS disease or hemoglobin S trait precluding the patient's ability to use G-CSF.
- History of steroid-induced psychosis or encephalopathy requiring medical intervention.
- History of type I or II diabetes mellitus that is poorly controlled or with high glucose variability precluding safe administration of dexamethasone 12mg IV as premedication in the opinion of the investigator.
- History of serious systemic reaction to motixafortide.
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 |
|---|---|---|
| AcetaminophenAlso: Acetaminophen (APAP), Paracetamol, TylenolGiven by mouth (PO). | Drug | Arm I (Dexamethasone), Arm II (Methylprednisolone) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Arm I (Dexamethasone), Arm II (Methylprednisolone) |
| DexamethasoneAlso: Aacidexam, Adexone, Aknichthol Dexa, Alba-DexGiven intravenously (IV). | Drug | Arm I (Dexamethasone) |
| Electronic Health Record ReviewAncillary studies | Other | Arm I (Dexamethasone), Arm II (Methylprednisolone) |
| FamotidineAlso: Pepcid, Pepcid ACGiven by mouth (PO). | Drug | Arm I (Dexamethasone), Arm II (Methylprednisolone) |
| LoratadineAlso: ClaritinGiven by mouth (PO). | Drug | Arm I (Dexamethasone), Arm II (Methylprednisolone) |
| MethylprednisoloneAlso: Adlone, Caberdelta M, DepMedalone, Depo ModerinGiven intravenously (IV). | Drug | Arm II (Methylprednisolone) |
| MontelukastGiven by mouth (PO). | Drug | Arm I (Dexamethasone), Arm II (Methylprednisolone) |
| MotixafortideAlso: 4F-Benzoyl-TN14003, BKT 140, BKT-140, BKT140Given subcutaneously (SC). | Drug | Arm I (Dexamethasone), Arm II (Methylprednisolone) |
| PheresisAlso: Apheresed, Apheresis, Blood Component Removal, Collection, Apheresis/LeukapheresisUndergo apheresis | Procedure or surgery | Arm I (Dexamethasone), Arm II (Methylprednisolone) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (Dexamethasone), Arm II (Methylprednisolone) |
| Recombinant Granulocyte Colony-Stimulating FactorAlso: Recombinant Colony-Stimulating Factor 3, rhG-CSFGive Granulocyte Colony-Stimulating Factor (G-CSF). | Biological | Arm I (Dexamethasone), Arm II (Methylprednisolone) |
Primary outcome
Incidence and severity of systemic reactions
Time frame: At day 4 and 5
Will compare the incidence and severity of systemic reactions after administration of motixafortide. Systemic reactions will be graded as per Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Analysis will be based upon an intent-to-treat analysis of all subjects who are randomized to receive dexamethasone or methylprednisolone. Will evaluate the proportion of patients who develop systemic reactions stratified by grade associated with motixafortide between the two premedication regimens. The non-inferiority probability (p)-value between the two arms will be carried out using one-sided z-test. In addition, these two groups will be compared at patient level using chi-square test or Fisher's Exact test. A logistic regression will be used to estimate the odd ratio between the two arms controlling for the baseline covariates for an improved precision of the estimation.
Incidence and severity of injection site reactions
Time frame: At day 4 and 5
Will compare the incidence and severity of injection site reactions after administration of motixafortide. Injection site reactions will be graded as per CTCAE v5.0. The incidence of injection site reactions after administration of motixafortide between the two premedication regimens will be similarly compared to that of the incidence and severity of systemic reactions.
4 secondary outcomes
Compare Tolerability Between Regimens
Time frame: At days 4 and 5
CD34+ hematopoietic stem and progenitor cells (HSPC)/kg collection
Time frame: Up to day 8
Collection of >= 6 x 10^6 CD34+ HSPC/kg
Time frame: At day 5
Cytokine levels
Time frame: At days 4 and 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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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.
Joseph Rimando, MD principal investigator
Emory University Hospital/Winship Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen, Biospecimen Collection and Dexamethasone in people with Multiple Myeloma, run by Emory University 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 23 Jul 2026. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Rimando, MD (404-778-1900, joseph.cataquiz.rimando@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of systemic reactions (time frame: At day 4 and 5). The study lists 2 primary outcomes in all. 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 23 Jul 2026.