Phase 1 Dose Escalation for Multiple Myeloma

Debreceni Egyetem - Orvos es Egeszsegtudomanyi Centrum (DEOEC) (University of Debrecen Medical and Health Science Center), Debrecen, Hungary
Multiple MyelomaModakafusp Alfa - Drug
Eligibility
18+
All Sexes

Study Summary

This trial will study the safety and effectiveness of a new drug given with an existing drug to find the best dose for treating cancer.

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

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1
Dose Escalation (Phase 1)
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BIIB132
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VOB560-MIK665 - Part 2a

Study Objectives

3 Primary · 30 Secondary · Reporting Duration: Up to 60 months

Day 28
Phase 1: Number of Participants with Dose Limiting Toxicities (DLT)
Day 28
Phase 1: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to Time of the Last Quantifiable Concentration
Phase 1: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to Time of the Last Quantifiable Concentration for Daratumumab
Phase 1: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa
Phase 1: AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for Daratumumab
Phase 1: Apparent Serum Terminal Disposition Phase Half-life for Modakafusp Alfa
Phase 1: Apparent Serum Terminal Disposition Rate Constant for Modakafusp Alfa
Phase 1: Cmax: Single-Dose Maximum Observed Serum Concentration for Daratumumab
Phase 1: Cmax: Single-Dose Maximum Observed Serum Concentration for Modakafusp Alfa
Phase 1: Ctrough: Single-Dose and Multiple-dose Observed Concentration at the End of a Dosing Interval for Daratumumab
Phase 1: Tmax: Time to First Occurrence of Maximum Serum Concentration (Cmax) for Daratumumab
Phase 1: Tmax: Time to First Occurrence of Maximum Serum Concentration (Cmax) for Modakafusp Alfa
Phase 1: Total Clearance After Intravenous Administration for Modakafusp Alfa
Phase 1: Volume of Distribution at Steady State After Intravenous Administration for Modakafusp Alfa
Up to 60 months
Phase 1 and Phase 2a: Duration of Measurable [Minimal] Residual Disease (MRD) Negativity
Phase 1 and Phase 2a: Duration of Response (DOR)
Phase 1 and Phase 2a: Number of Participants With Anti-drug Antibodies
Phase 1 and Phase 2a: Number of Participants With Neutralizing Antibodies (NAb) Against Study Drug
Phase 1 and Phase 2a: Overall Survival (OS)
Phase 1 and Phase 2a: Rate of Measurable [Minimal] Residual Disease Negative (MRD[-]) Complete Response (CR)
Phase 1 and Phase 2a: Titer of Anti-drug Antibodies
Therapeutic procedure
Phase 1: Overall Response Rate (ORR)
Phase 2a: Clinical Benefit Rate (CBR)
Phase 2a: Disease Control Rate (DCR)
Phase 2a: Duration of Clinical Benefit (DCB)
Phase 2a: Duration of Disease Control
Therapeutic procedure
Phase 2a: Overall Response Rate (ORR)
Phase 2a: Time to Next Treatment (TTNT)
Phase 2a: Time to Progression (TTP)
Phase 2a: Time to Response (TTR)
up to 60 months
Phase 1 and Phase 2a: Progression Free Survival (PFS)

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Dose Escalation (Phase 1)
1
BIIB132
1
VOB560-MIK665 - Part 2a

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

3 Treatment Groups

Phase 1 Dose Escalation
1 of 3
Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab
1 of 3
Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab
1 of 3

Experimental Treatment

58 Total Participants · 3 Treatment Groups

Primary Treatment: Phase 1 Dose Escalation · No Placebo Group · Phase 1 & 2

Phase 1 Dose EscalationExperimental Group · 2 Interventions: Modakafusp Alfa, Daratumumab · Intervention Types: Drug, Drug
Phase 2a Dose Finding: Modakafusp Alfa (DL1) + DaratumumabExperimental Group · 2 Interventions: Modakafusp Alfa, Daratumumab · Intervention Types: Drug, Drug
Phase 2a Dose Finding: Modakafusp Alfa (DL2) + DaratumumabExperimental Group · 2 Interventions: Modakafusp Alfa, Daratumumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2016
Completed Phase 3
~1740

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 60 months

Who is running the clinical trial?

TakedaLead Sponsor
1,149 Previous Clinical Trials
4,057,980 Total Patients Enrolled
50 Trials studying Multiple Myeloma
18,558 Patients Enrolled for Multiple Myeloma
Study DirectorStudy DirectorTakeda
1,106 Previous Clinical Trials
481,666 Total Patients Enrolled
24 Trials studying Multiple Myeloma
4,553 Patients Enrolled for Multiple Myeloma

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

Are there current openings for this clinical trial?

"As confirmed by clinicaltrials.gov, this experiment has been actively recruiting since its publication on the 3rd of January 2023 with last edit occuring on December 23 2022." - Anonymous Online Contributor

Unverified Answer

What is the total sample size of this clinical research?

"To move forward with this medical trial, 58 patients need to be enrolled that meet the predetermined inclusion criteria. Potential participants can register from Cedars-Sinai Medical Center in Los Angeles or James R Berenson, MD Inc. located in West Hollywood." - Anonymous Online Contributor

Unverified Answer

In what number of health care facilities is this experiment currently being conducted?

"This trial is enrolling patients in Cedars-Sinai Medical Center, James R Berenson MD Inc., and Fort Wayne Medical Oncology & Hematology Inc. as well as 17 additional sites." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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