94 Participants Needed

Methylprednisolone vs Dexamethasone for Multiple Myeloma

JR
EK
Overseen ByEdmund K. Waller, MD, PhD, FACP
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Emory University
Must be taking: Corticosteroids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to prevent allergic reactions in people with multiple myeloma who receive motixafortide before stem cell mobilization. Researchers are comparing two medications, methylprednisolone and dexamethasone, to determine which one better reduces side effects. Individuals diagnosed with multiple myeloma and preparing for a stem cell transplant might be suitable for this study. Participants will receive either methylprednisolone or dexamethasone before taking motixafortide. As a Phase 4 trial, this study involves an FDA-approved treatment and focuses on understanding its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What is the safety track record for these treatments?

Research has shown that both dexamethasone and methylprednisolone are generally well-tolerated as premedication treatments for patients with multiple myeloma. Dexamethasone often reduces allergic reactions to motixafortide during stem cell mobilization, but it can cause side effects like headaches, trouble sleeping, and high blood pressure.

Researchers are studying methylprednisolone, another steroid, as a potentially safer or more effective option. Although specific data on methylprednisolone's safety in this context is limited, some studies suggest it may be well-tolerated and effective in reducing allergic reactions.

Since this is a Phase 4 trial, earlier studies have already demonstrated that both treatments are somewhat safe. This phase typically focuses on comparing existing treatments to identify the best option for patients.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using methylprednisolone and dexamethasone for treating multiple myeloma because these corticosteroids offer different potential benefits. Unlike the standard treatments, such as lenalidomide or bortezomib, which primarily target cancer cells through different mechanisms, methylprednisolone and dexamethasone work by reducing inflammation and modulating the immune response. This anti-inflammatory action might help alleviate symptoms and enhance the effectiveness of other treatments. Additionally, methylprednisolone is being explored for its experimental use, which could provide insights into optimizing dosing or timing for better outcomes.

What evidence suggests that this trial's treatments could be effective for preventing allergic reactions in multiple myeloma patients?

This trial will compare Dexamethasone and Methylprednisolone for managing multiple myeloma. Research has shown that Dexamethasone is commonly used to prevent allergic reactions during stem cell mobilization in patients with multiple myeloma. Studies have found that lowering the dose of Dexamethasone does not harm patient outcomes, making it a dependable option. However, it can cause side effects like high blood pressure and mood changes.

Meanwhile, Methylprednisolone, which participants in another arm of this trial may receive, is being studied as a possible alternative. Patients who have used Methylprednisolone have responded well, and some studies suggest it may even improve overall survival. It works by changing how the immune system reacts, which might help lessen allergic reactions. This indicates that Methylprednisolone could be a safe and possibly more effective choice for managing reactions during treatment.23467

Who Is on the Research Team?

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Joseph Rimando, MD

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

This trial is for patients with multiple myeloma who are undergoing stem cell mobilization, a process needed before autologous stem cell transplantation. The study seeks individuals who need to prevent allergic reactions to motixafortide, a drug used in this procedure.

Inclusion Criteria

Patient must understand and voluntarily sign an informed consent form
Females of reproductive potential must use effective contraception during treatment with motixafortide and for 8 days after the final dose
I am 18 years old or older.
See 3 more

Exclusion Criteria

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
I cannot use G-CSF due to my sickle cell disease/trait.
History of serious systemic reaction to motixafortide
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive premedication regimens with either dexamethasone or methylprednisolone, followed by motixafortide and stem cell mobilization procedures

8 days
Daily visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Dexamethasone
  • Methylprednisolone
  • Pheresis
Trial Overview The PARADE trial is comparing two premedication regimens: one using methylprednisolone and the other using dexamethasone. Both drugs aim to reduce allergic reactions to motixafortide during stem cell mobilization in multiple myeloma patients.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (Methylprednisolone)Experimental Treatment12 Interventions
Group II: Arm I (Dexamethasone)Active Control11 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Gamida Cell ltd

Industry Sponsor

Trials
9
Recruited
290+

Citations

DexamethasoneData from both studies showed that dexamethasone dose reductions did not have a negative impact on outcomes in patients with newly diagnosed multiple myeloma ( ...
Dexamethasone dose intensity does not impact outcomes in ...Our study suggests that dexamethasone dose reductions are common in multiple myeloma, even within clinical trials. Given the many toxicities and ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39321347/
Dexamethasone dose intensity does not impact outcomes in ...Our study suggests that dexamethasone dose reductions are common in multiple myeloma, even within clinical trials.
An analysis of real-world electronic health records dataThis retrospective longitudinal study compared the effectiveness of dexamethasone+lenalidomide (Rd)-based triplet regimens containing proteasome inhibitors ...
Mezigdomide plus Dexamethasone in Relapsed and ...An overall response occurred in 41% of the patients (95% confidence interval [CI], 31 to 51), the median duration of response was 7.6 months (95% CI, 5.4 to 9.5 ...
Safety and efficacy of a dexamethasone-sparing regimen ...AEs leading to death occurred in 23 patients (12%) in the dexamethasone-sparing group and 12 patients (13%) in the control group, with 4 (2%) and 2 (2%) grade 5 ...
Safety Study of Lenalidomide/Dexamethasone to Treat ...This study aims to assess the real-life safety of Lenalidomide/Dexamethasone (Len/Dex) in patients with (Relapsed or Refractory Multiple Myeloma (rrMM), by ...
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