TAK-573 for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Multiple MyelomaTAK-573 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the safety and efficacy of modakafusp alfa in people with relapsed or refractory multiple myeloma.

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Study Objectives

20 Primary · 57 Secondary · Reporting Duration: Up to 1 year

Day 28
Part 1: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp alfa
Day 28
AUClast: Area Under the Serum Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for TAK-573
AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for TAK-573
CL: Clearance for TAK-573
Cmax: Maximum Observed Serum Concentration for TAK-573
Part 1: AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for Modakafusp alfa
Part 1: CL: Clearance for Modakafusp alfa
Part 1: Cmax: Maximum Observed Serum Concentration for Modakafusp alfa
Part 1: T1/2: Terminal Elimination Half-life for Modakafusp alfa
Part 1: Tmax: Time to Reach the Cmax for Modakafusp alfa
Part 1: Vss: Volume of Distribution at Steady State for Modakafusp alfa
Part 1: λz: Terminal Disposition Rate Constant for Modakafusp alfa
T1/2: Terminal Elimination Half-life for TAK-573
Tmax: Time to Reach the Cmax for TAK-573
Vss: Volume of Distribution at Steady State for TAK-573
λz: Terminal Disposition Rate Constant for TAK-573
Up to 1 year
Percentage of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
Phase 1- Clinical Benefit Rate (CBR)
Phase 1- DOR
Phase 1- Disease Control Rate (DCR)
Phase 1- ORR
Phase 1- PFS
Phase 1- Percentage of Participants Reporting one or More TEAEs, Serious Adverse Events, >=Grade 3 TEAEs, Dose Modification, Adverse Events Leading to Discontinuation of Study Drug, Clinically Significant Laboratory Values and Vital Signs
Phase 1- Time to Response
Phase 2- Clinical Benefit Rate (CBR)
Phase 2- Disease Control Rate (DCR)
Phase 2- Duration of Response (DOR)
Phase 2- Overall Response Rate (ORR)
Phase 2- Percentage of Participants Reporting one or More TEAEs, Dose Modification, Leading to Discontinuation of Study Drug, DLT-like, Clinically Significant Laboratory Values and Vital Signs
Phase 2- Progression-free Survival (PFS)
Phase 2- Time to Response
Day 28
Mutagenicity Tests
Phase 1- Percentage of Participants With Dose-limiting Toxicities (DLTs)
Month 90
Part 1 and 2: Percentage of Participants With Dose-limiting Toxicities (DLTs)- Like Events
Part 1: Objective Response Rate (ORR)
Part 1: Percentage of Participants Reporting one or More Grade 3 TEAEs
Part 1: Percentage of Participants Reporting one or More Serious Adverse Events (SAEs)
Part 1: Percentage of Participants Reporting one or More Treatment Emergent Adverse Events (TEAEs)
Part 1: Percentage of Participants Who Discontinue the Treatment Because of TEAE
Part 1: Percentage of Participants With Clinically Significant Laboratory Values
Part 1: Percentage of Participants With Clinically Significant Vital Signs Measurements
Part 1: Percentage of Participants With Dose Modifications: Dose Delay
Part 1: Percentage of Participants With Dose Modifications: Dose Interruptions
Part 1: Percentage of Participants With Dose Modifications: Dose Reductions
Part 2: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp alfa
Part 2: AUC∞: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for Modakafusp alfa
Part 2: CL: Clearance for Modakafusp alfa
Part 2: Cmax: Maximum Observed Serum Concentration for Modakafusp alfa
Part 2: Overall Response Rate (ORR)
Part 2: T1/2z: Terminal Elimination Half-life for Modakafusp alfa
Part 2: Tmax: Time to Reach the Cmax for Modakafusp alfa
Part 2: Vss: Volume of Distribution at Steady State for Modakafusp alfa
Part 2: λz: Terminal Disposition Rate Constant for Modakafusp alfa
Part 3: Clinical Benefit Rate (CBR) by IRC and Investigator assessment
Part 3: Disease Control Rate (DCR) by IRC and Investigator Assessment
Part 3: Duration of Clinical Benefit
Part 3: Duration of Disease Control
Part 3: Health Care Utilization: Length of Hospital Stays
Part 3: Health Care Utilization: Number of Participants With at Least One Medical Encounter
Part 3: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Status
Part 3: Objective Response Rate (ORR) by Investigator Assessment
Part 3: Overall Response Rate (ORR) Assessed by Independent Review Committee (IRC)
Part 3: Patient-reported Outcome (PRO): Instrument European Organisation for Research and Treatment of Cancer QLQ Questionnaire Multiple Myeloma Module (EORTC QLQ-MY20)
Part 3: Percentage of Participants With Adverse Events (AEs)
Part 3: Percentage of Participants With Clinically Significant Laboratory Values
Part 3: Percentage of Participants With Neutralizing Antibodies (NAb)
Part 3: Percentage of Participants With Serious Adverse Events (SAEs)
Part 3: Rate of Minimal Residual Disease (MRD) Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR
Part 3: Time to Progression (TTP) by IRC and Investigator Assessment
Part 3:Duration of MRD Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR
Parts 1 and 2: Clinical Benefit Rate (CBR)
Parts 1 and 2: Disease Control Rate (DCR)
Parts 1 and 2: Time to Response
Parts 1, 2 and 3: Duration of Response (DOR)
Parts 1, 2 and 3: Percentage of Participants with Positive Anti-drug Antibodies (ADA)
Parts 1, 2 and 3: Progression Free Survival (PFS)
Parts 2 and 3: Overall Survival (OS)

Trial Safety

Trial Design

12 Treatment Groups

Phase 2: TAK-573 TBD
1 of 12
Part 1 (Dose Escalation) Schedule A: Modakafusp alfa 0.001 Up to 14 mg/kg
1 of 12
Part 1 (Dose Escalation) Schedule B: Modakafusp alfa TBD
1 of 12
Phase 1 Schedule B: TAK-573 TBD
1 of 12
Phase 1 Schedule A: TAK-573 0.001 to 14 mg/kg
1 of 12
Phase 1 Schedule C: TAK-573 TBD
1 of 12
Phase 1 Schedule D: TAK-573 TBD
1 of 12
Part 1 (Dose Escalation) Schedule D: Modakafusp alfa TBD
1 of 12
Part 3 (Dose Extension): Modakafusp alfa 120 mg
1 of 12
Part 1 (Dose Escalation) Schedule C: Modakafusp alfa TBD
1 of 12
Part 2 (Dose Expansion): Modakafusp alfa TBD + Dexamethasone 40 mg
1 of 12
Part 3 (Dose Extension): Modakafusp alfa 240 mg
1 of 12

Experimental Treatment

336 Total Participants · 12 Treatment Groups

Primary Treatment: TAK-573 · No Placebo Group · Phase 1 & 2

Phase 2: TAK-573 TBDExperimental Group · 2 Interventions: TAK-573, Dexamethasone · Intervention Types: Drug, Drug
Part 1 (Dose Escalation) Schedule A: Modakafusp alfa 0.001 Up to 14 mg/kg
Drug
Experimental Group · 1 Intervention: Modakafusp alfa · Intervention Types: Drug
Part 1 (Dose Escalation) Schedule B: Modakafusp alfa TBD
Drug
Experimental Group · 1 Intervention: Modakafusp alfa · Intervention Types: Drug
Phase 1 Schedule B: TAK-573 TBD
Drug
Experimental Group · 1 Intervention: TAK-573 · Intervention Types: Drug
Phase 1 Schedule A: TAK-573 0.001 to 14 mg/kg
Drug
Experimental Group · 1 Intervention: TAK-573 · Intervention Types: Drug
Phase 1 Schedule C: TAK-573 TBD
Drug
Experimental Group · 1 Intervention: TAK-573 · Intervention Types: Drug
Phase 1 Schedule D: TAK-573 TBD
Drug
Experimental Group · 1 Intervention: TAK-573 · Intervention Types: Drug
Part 1 (Dose Escalation) Schedule D: Modakafusp alfa TBD
Drug
Experimental Group · 1 Intervention: Modakafusp alfa · Intervention Types: Drug
Part 3 (Dose Extension): Modakafusp alfa 120 mg
Drug
Experimental Group · 1 Intervention: Modakafusp alfa · Intervention Types: Drug
Part 1 (Dose Escalation) Schedule C: Modakafusp alfa TBD
Drug
Experimental Group · 1 Intervention: Modakafusp alfa · Intervention Types: Drug
Part 2 (Dose Expansion): Modakafusp alfa TBD + Dexamethasone 40 mgExperimental Group · 2 Interventions: Modakafusp alfa, Dexamethasone · Intervention Types: Drug, Drug
Part 3 (Dose Extension): Modakafusp alfa 240 mg
Drug
Experimental Group · 1 Intervention: Modakafusp alfa · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year

Who is running the clinical trial?

Millennium Pharmaceuticals, Inc.Lead Sponsor
404 Previous Clinical Trials
51,697 Total Patients Enrolled
82 Trials studying Multiple Myeloma
9,654 Patients Enrolled for Multiple Myeloma
TakedaLead Sponsor
1,116 Previous Clinical Trials
4,053,794 Total Patients Enrolled
45 Trials studying Multiple Myeloma
16,879 Patients Enrolled for Multiple Myeloma
Medical Director Clinical ScienceStudy DirectorMillennium Pharmaceuticals, Inc.
195 Previous Clinical Trials
62,896 Total Patients Enrolled
8 Trials studying Multiple Myeloma
2,351 Patients Enrolled for Multiple Myeloma
Study DirectorStudy DirectorTakeda
1,068 Previous Clinical Trials
475,063 Total Patients Enrolled
22 Trials studying Multiple Myeloma
3,860 Patients Enrolled for Multiple Myeloma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are refractory to or intolerant of at least 1 PI and a least 1 IMiD.
You have a serum M-protein level of 500 mg/dL (5 g/L) or higher.
You have myeloma and need additional therapy.
You have received at least 3 lines of myeloma therapy.
You have a performance status of ≤2.