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Protein Synthesis Inhibitor

Daratumumab and Hyaluronidase-fihj for Multiple Myeloma

Phase 1
Waitlist Available
Led By Abdullah M Khan, MBBS, MSc
Research Sponsored by Abdullah Khan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Serum M-protein >= 0.5 g/dl (>= 10 g/l)
Urine monoclonal protein >= 200 mg/24h
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial studies the side effects and possible benefits of adding panobinostat to a combination of other drugs for patients with relapsed or refractory multiple myeloma.

Eligible Conditions
  • Multiple Myeloma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Recommended phase 2 dose
Secondary outcome measures
Duration of overall response
Objective response rate (ORR)
Overall survival
+3 more
Other outcome measures
Changes in lymphocyte subsets with therapy
Minimal residual disease negativity rates by next generation sequencing in patients who attain and maintain very good partial response or better for at least three months
Plasma cell expression of CD38
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (panobinostat, daratumumab, bortezomib, dexa)Experimental Treatment4 Interventions
Patients receive panobinostat PO QD on days 1, 3, 5, 15, 17, 19, daratumumab and hyaluronidase-fihj SC on days 1, 8, 15, 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of subsequent cycles, bortezomib SC on days 1, 8, 15, 22 and dexamethasone PO (IV on days of daratumumab and hyaluronidase-fihj administration) QD on days 1, 8, 15, 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Bortezomib
2005
Completed Phase 2
~1140

Find a Location

Who is running the clinical trial?

Abdullah KhanLead Sponsor
1 Previous Clinical Trials
27 Total Patients Enrolled
1 Trials studying Multiple Myeloma
27 Patients Enrolled for Multiple Myeloma
Abdullah M Khan, MBBS, MScPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
27 Total Patients Enrolled
1 Trials studying Multiple Myeloma
27 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.

What indications do Daratumumab and Hyaluronidase-fihj address?

"Daratumumab and Hyaluronidase-fihj is a mainstream treatment for ophthalmia, sympathetic. Additionally, it has been successful in addressing branch retinal vein occlusion, macular edema, as well as communicable diseases."

Answered by AI

What other experiments have been conducted that involve Daratumumab and Hyaluronidase-fihj?

"This particular treatment, Daratumumab and Hyaluronidase-fihj, is currently under investigation in 686 clinical trials. 159 of these are Phase 3 studies located mainly in Hefei but also at 22940 locations around the world."

Answered by AI

Is this experimental trial open to elderly participants?

"This trial seeks participants between the age of majority and 75 years old."

Answered by AI

What are the major aims of this experiment?

"This 3 year trial will assess the recommended phase 2 dose for efficacy. Secondary assessment criteria include duration of overall response, time to response and progression-free survival which are all evaluated by employing Kaplan-Meier methods with 95% confidence intervals as well as log-rank test across patient subgroups."

Answered by AI

Is it permissible for me to participate in this trial?

"The current medical trial seeks 27 individuals that have multiple myeloma, between 18 and 75 years of age. To qualify for the study, applicants must have had a prior course of therapy incorporating lenalidomide or cyclophosphamide, V or other PI with/without ASCT - however those who experienced progression within 120 days after their last treatment are ineligible. Additionally, participants should not be in receipt of any treatments two weeks before enrolling on this program."

Answered by AI

Are researchers still enrolling participants in this experiment?

"Affirmative, the clinicaltrials.gov directory confirms that this medical trial is currently in search of participants. Initially posted on September 27th 2021 and recently updated on November 30th 2021, the study requires 27 individuals at one site to participate."

Answered by AI

Has the FDA sanctioned utilization of Daratumumab and Hyaluronidase-fihj?

"The safety of Daratumumab and Hyaluronidase-fihj is estimated to be on the lower end, with a score of 1. This reflects its status as a Phase 1 trial which has little evidence showing efficacy or safety."

Answered by AI

How many individuals are participating in this experiment?

"Affirmative. Clinicaltrials.gov indicates that this clinical trial is currently recruiting participants, with the initial posting of September 27th 2021 and a subsequent update on November 30th 2021. As such, 1 medical centre needs to enrol 27 patients in total."

Answered by AI
~0 spots leftby Mar 2025