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Corticosteroid

ON 123300 (NARAZACICLIB) + dexamethasone for Multiple Myeloma

Phase 1 & 2
Waitlist Available
Led By Adriana Rossi, MD
Research Sponsored by Adriana Rossi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 2 months of treatment initiation, whichever comes first, for a maximum up to 2 years after enrollment
Awards & highlights

Study Summary

This trial aims to test a new oral medication called ON 123300 (NARAZACICLIB) in combination with dexamethasone for the treatment of multiple myeloma. The

Who is the study for?
This trial is for people with multiple myeloma, a type of blood cancer, who have tried other treatments that didn't work or stopped working. Participants should be able to take oral medication and handle steroid treatment.Check my eligibility
What is being tested?
Researchers are testing ON 123300 (Narazaciclib), a new pill that targets specific proteins in cancer cells, combined with dexamethasone, a steroid. They want to see if this combo is safe and helps control the disease better than current options.See study design
What are the potential side effects?
Possible side effects include those common to cancer-targeting drugs like fatigue, nausea, diarrhea, low blood counts leading to increased infection risk or bleeding. Dexamethasone can cause mood swings, high blood sugar levels, and insomnia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 2 months of treatment initiation, whichever comes first, for a maximum up to 2 years after enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 2 months of treatment initiation, whichever comes first, for a maximum up to 2 years after enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase I: Dose-Limiting Toxicity (DLT) rate
Phase I: The optimal biological dose (OBD) of the combination of ON 123300 (NARAZACICLIB) and dexamethasone
Phase II: Overall response rates (ORR)
Secondary outcome measures
Best overall response (BOR)
Disease Control Rate (DCR)
Duration of Response (DOR)
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ON 123300 (NARAZACICLIB) + dexamethasoneExperimental Treatment2 Interventions
Participants will continue 28-day cycles of ON 123300 (NARAZACICLIB) + dexamethasone as long as the drug shows anti-myeloma activity with a disease response ≥PR (PR, VGPR, CR) and the patient does not exhibit any DLTs and the study is open. Patients will continue the regimen until disease progression/intolerable toxicity/death, withdrawal OR for a maximum up to 2 years after enrollment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

Adriana RossiLead Sponsor
Samir Parekh, MBBSStudy DirectorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
6 Total Patients Enrolled
1 Trials studying Multiple Myeloma
6 Patients Enrolled for Multiple Myeloma
Adriana Rossi, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Multiple Myeloma
12 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for patients to participate in this research study?

"Per clinicaltrials.gov data, recruitment for this research initiative is currently inactive. Initial publication was on 6/3/2024 with the most recent update on 4/2/2024. Despite its temporary closure to participants, it's noteworthy that there are a substantial 812 other active studies seeking enrollees presently."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
ON 123300 (Narazaciclib) and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
Adriana Rossi 2024. "ON 123300 (Narazaciclib) and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06351644.
~24 spots leftby Jun 2028
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