Relapsed and/or Refractory Multiple MyelomaPhase 1NCT04392648
A Study to Evaluate the Safety, Tolerability and Efficacy of Intravenous TAK-573 as Part of Combination Therapy in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
A Phase 1 study testing TAK-573, Pomalidomide and Bortezomib in people with Relapsed and/or Refractory Multiple Myeloma, run by Teva Branded Pharmaceutical Products R&D LLC.
Trial summary
The purpose of this study is to determine the safety, tolerability, and recommended phase 2 dose (RP2D) of TAK-573 when used with dexamethasone and in combination with bortezomib, pomalidomide, or cyclophosphamide, in participants with RRMM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed and/or Refractory Multiple Myeloma
- What is being tested?
- TAK-573, Pomalidomide and Bortezomib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 24 Jun 2020to 10 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Received >=2 prior lines of therapy, including treatment with lenalidomide and a proteasome inhibitor.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- With measurable disease, defined as at least 1 of the following:
- Serum M protein >=500 mg/dL (>=5 gram per liter [g/L]) on serum protein electrophoresis (SPEP).
- Urine M protein >=200 mg/24 hours on urine protein electrophoresis (UPEP).
- Serum FLC assay result with an involved FLC level >=10 mg/dL (>=100 milligram per liter [mg/L]), provided the serum FLC ratio is abnormal.
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- Has adequate organ function as determined by the following laboratory values:
- Absolute neutrophil count (ANC) >=1000 per cubic millimeter (/mm^3) (>=1.0*10^9 [per liter]/L)
- Platelets >=75,000/mm^3 (>=75*10^9/L)
- Hemoglobin >=80 g/L
- Creatinine clearance >=30 milliliter per minute (mL/min)
- Total serum bilirubin <=1.5*upper limit normal (ULN), >=2.0*ULN for participants with Gilbert's syndrome
- Liver transaminases (alanine aminotransferase [ALT]/ aspartate aminotransferase [AST]) Serum ALT or AST <=3.0*ULN (<5*ULN if enzyme elevations are due to MM-related diffuse hepatic infiltrations).
- Has received the final dose of any of the following treatments/procedures within the specified minimum intervals before first dose of TAK-573:
- Chemotherapy, including proteasome inhibitors and immunomodulatory imide drug.(IMiDs) 14 days
- Antimyeloma antibody therapy 21 days
- Corticosteroid therapy for myeloma 7 days
- Radiation therapy for localized bone lesions 7 days
- Major surgery 21 days.
Who cannot join
- Has polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin changes (POEMS) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, solitary plasmacytoma, amyloidosis, Waldenström macroglobulinemia or IgM myeloma, lymphoplasmacytic lymphoma, or plasma cell leukemia.
- Previous intolerance to combination agent.
- For the pomalidomide expansion group only: no prior treatment with pomalidomide.
- Inability to take prophylaxis needed for combination agent (deep vein thrombosis prophylaxis for pomalidomide, antiviral prophylaxis for proteasome inhibitor).
- Who have received autologous stem cell transplant (SCT) within 60 days before first infusion of TAK-573 or participants who have received allogeneic SCT 6 months before first infusion. Graft-versus-host disease that is active or requires ongoing systemic immunosuppression.
- Has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade <=1 or baseline, except for sensory or motor neuropathy which should have recovered to Grade <=2 or baseline, Grade <2 for participants receiving bortezomib.
- Has a chronic condition requiring the use of systemic corticosteroids >10 milligram per day (mg/day) of prednisone or equivalent.
About this study
Official title: A Phase 1 Open-label Study to Evaluate the Safety, Tolerability and Efficacy of Intravenous TAK-573 as Part of Combination Therapy in Patients With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to determine the safety, tolerability, and recommended phase 2 dose (RP2D) of TAK-573 when used with dexamethasone and in combination with bortezomib, pomalidomide, or cyclophosphamide, in participants with RRMM.
Read the detailed description
The drug that is being tested in this study is called TAK-573. The study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TAK-573 when used in combination with dexamethasone and either bortezomib, pomalidomide or cyclophosphamide in participants with RRMM.
The study will be conducted in 2 phases: Dose Escalation Phase and Dose Expansion Phase. The study will enroll approximately 135 participants (approximately 60 participants in Dose Escalation Phase and approximately 75 participants in Dose Expansion Phase). The dose escalation phase will determine the recommended dose of TAK-573 along with the combination agents for the dose expansion phase.
This multi-center trial will be conducted in the United States, Germany, France, Spain, and Canada. The overall time to participate in this study is approximately 3 years. Participants will be followed up for 30 days after the last dose of study drug for a follow-up assessment.
- Being tested
- TAK-573, Pomalidomide, Bortezomib, Cyclophosphamide, Dexamethasone
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-573Drug
TAK-573 intravenous infusion.
PomalidomideDrug
Pomalidomide capsules orally.
BortezomibDrug
Bortezomib injection subcutaneously.
CyclophosphamideDrug
Cyclophosphamide tablets orally.
DexamethasoneDrug
Dexamethasone tablets orally.
| Study group | Role | What they receive |
|---|---|---|
| Escalation:TAK-573 0.1-1.5mg/kg+Bortezomib+Dexamethasone | Experimental | TAK-573 0.1 to 1.5 milligram per kilogram (mg/kg), infusion, intravenously, once, every 3 weeks in a 21-days treatment cycle, along with bortezomib 1.3 milligram per square meter (mg/m^2), injection, subcutaneously, once on Days 1, 4, 8, and 11 and dexamethasone 40 milligram (mg) (20 mg if aged more than 75 years), tablets, orally on Days 1, 8, and 15 in each 21-days treatment cycle from Cycle 1 through Cycle 8. For participants who continue beyond Cycle 8, TAK-573 will be given as an infusion, intravenously, once, every 3 weeks in a 21-days treatment cycle with dexamethasone 40 mg (20 mg if aged more than 75 years), tablets, orally from Cycle 9 through Cycle 17. Receives: Drug: TAK-573; Drug: Bortezomib; Drug: Dexamethasone |
| Escalation:TAK-573 0.05-0.75mg/kg+Pomalidomide+Dexamethasone | Experimental | TAK-573 0.05 to 0.75 mg/kg, infusion, intravenously, once, every 4 weeks in a 28-days treatment cycle, along with pomalidomide 4 mg, capsules, orally, once daily from Days 1 through 21 and dexamethasone 40 mg (20 mg if aged more than 75 years), tablets, orally, once on Days 1, 8, 15, and 22 in each 28-days treatment cycle from Cycle 1 through Cycle 17. Receives: Drug: TAK-573; Drug: Pomalidomide; Drug: Dexamethasone |
| Escalation:TAK-573 0.1-1.5mg/kg+Cyclophosphamide+Dexamethasone | Experimental | TAK-573 0.1 to 1.5 mg/kg, infusion, intravenously, once, every 4 weeks in a 28-days treatment cycle, along with cyclophosphamide 300 mg/m^2, tablets, orally, once on Days 1, 8, and 15 and dexamethasone 40 mg (20 mg if aged more than 75 years), tablets, orally, once on Days 1, 8, 15, and 22 in each 28-days treatment cycle from Cycle 1 through Cycle 17. Receives: Drug: TAK-573; Drug: Cyclophosphamide; Drug: Dexamethasone |
| Expansion: TAK-573 + Bortezomib + Dexamethasone | Experimental | TAK-573, infusion, intravenously, once, every 3 weeks in a 21-days treatment cycle, along with bortezomib 1.3 mg/m^2, injection, subcutaneously, once on Days 1, 4, 8, and 11 and dexamethasone 40 mg (20 mg if aged more than 75 years), tablets, orally, once on Days 1, 8, and 15 in each 21-days treatment cycle until disease progression, intolerable toxicity, withdrawal from study, or death (up to 3 years). The dose of TAK-573 for Dose Expansion Phase will be the RP2D and recommended dose for expansion (RAD) determined in the previous Dose Escalation Phase. Receives: Drug: TAK-573; Drug: Bortezomib; Drug: Dexamethasone |
| Expansion: TAK-573 + Pomalidomide + Dexamethasone | Experimental | TAK-573, infusion, intravenously, once, every 4 weeks in a 28-days treatment cycle, along with pomalidomide 4 mg, capsules, orally, once daily from Days 1 through 21 and dexamethasone 40 mg (20 mg if aged more than 75 years), tablets, orally, once on Days 1, 8, 15, and 22 in each 28-days treatment cycle until disease progression, intolerable toxicity, withdrawal from study, or death (up to 3 years). The dose of TAK-573 for Dose Expansion Phase will be the RP2D and RAD determined in the previous Dose Escalation Phase. Receives: Drug: TAK-573; Drug: Pomalidomide; Drug: Dexamethasone |
| Expansion: TAK-573 + Cyclophosphamide + Dexamethasone | Experimental | TAK-573, infusion, intravenously, once, every 4 weeks in a 28-days treatment cycle, along with cyclophosphamide 300 mg/m^2, tablets, orally, once on Days 1, 8, and 15 and dexamethasone 40 mg (20 mg if aged more than 75 years), tablets, orally, once on Days 1, 8, 15, and 22 in each 28-days treatment cycle until disease progression, intolerable toxicity, withdrawal from study, or death (up to 3 years). The dose of TAK-573 for Dose Expansion Phase will be the RP2D and RAD determined in the previous Dose Escalation Phase. Receives: Drug: TAK-573; Drug: Cyclophosphamide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who Experienced at Least one Treatment Emergent Adverse Event (TEAE)
Measured: Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6)
Number of Participants with Clinically Significant Vital Signs Values, Clinically Significant Change From Baseline in Clinical Laboratory Values and 12-lead Electrocardiograms (ECG), and who Received any Concomitant Medications
Measured: Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6)
Dose Expansion Phase: Overall Response Rate (ORR)
ORR is defined as the percentage of participants who achieved confirmed partial response (PR) or better during the study as assessed with International Myeloma Working Group (IMWG) Uniform Response Criteria. PR: greater than or equal to (>=) 50 percent (%) reduction of serum M protein and >=90% reduction in urine M-protein or less than (<) 200 milligram per 24 hour (mg/24 hour), or >=50% decrease in uninvolved free light chain (FLC). At baseline, a >=50% decrease in size of soft tissue plasmacytomas is required.
Measured: Cycle 17 up to 3 years (Cycle length is equal to [=] 21 days in Arm 4 and is = 28 days in Arms 5 and 6)
Secondary outcomes (17)
Dose Escalation Phase, Cmax: Maximum Observed Serum Concentration for TAK-573
Measured: Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3)
Dose Escalation Phase, Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAK-573
Measured: Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3)
Dose Escalation Phase, AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-573
Measured: Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3)
Dose Escalation Phase, AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-573
Measured: Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3)
Dose Escalation Phase, Lambda (λ) z: Apparent Serum Terminal Disposition Rate Constant for TAK-573
Measured: Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3)
Dose Escalation Phase, T1/2z: Apparent Serum Terminal Elimination Phase Half-life for TAK-573
Measured: Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3)
Dose Escalation Phase, CL: Total Clearance After Administration for TAK-573
Measured: Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3)
Dose Escalation Phase, Vss: Volume of Distribution at Steady State After Administration for TAK-573
Measured: Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3)
Percentage of Participants with Positive Antidrug Antibodies (ADA) for Anti-573
Measured: Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length is = 21 days in Arm 4 and = 28 days in Arms 5 and 6)
Dose Escalation Phase: ORR
ORR is defined as the percentage of participants who achieved confirmed PR or better during the study as assessed with IMWG Uniform Response Criteria. PR: >= 50% reduction of serum M protein and >=90% reduction in urine M-protein or <200 mg/24 hour, or >=50% decrease in uninvolved FLC. At baseline, a >=50% decrease in size of soft tissue plasmacytomas is required.
Measured: Up to Cycle 17 (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3)
Best Overall Response (BOR)
BOR is defined as the best response recorded after the first dose of any study drug until subsequent therapy for multiple myeloma (MM). BOR will be assessed as per IMWG uniform response criteria.
Measured: Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6)
Clinical Benefit Rate (CBR)
The CBR is defined as the percentage of participants who achieved an ORR along with the minimal response (MR) or better during the study as assessed with IMWG Uniform Response Criteria. ORR is defined as the percentage of participants who achieved confirmed PR or better during the study as assessed with IMWG Uniform Response Criteria. MR is defined as a >=25% but less than or equal to (<=) 49% reduction of serum M protein and reduction in 24-hour urine M protein by 50% to 89%. In addition, if present at baseline, 25% to 49% reduction in size of soft tissue plasmacytomas is also required. No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).
Measured: Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6)
Disease Control Rate (DCR)
The DCR is defined as the percentage of participants who achieved CBR along with a stable disease (SD) or better during the study as assessed with IMWG Uniform Response Criteria. The CBR is defined as the percentage of participants who achieved an ORR along with the minimal response (MR) or better during the study as assessed with IMWG Uniform Response Criteria. SD is defined as no known evidence of progressive or new bone lesions.
Measured: Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6)
Median Duration of Response (DOR)
DOR: number of days from first documentation of a confirmed response until progressive disease (PD) or until last adequate response assessment if there is no PD. DOR will be assessed as per IMWG uniform response criteria. PD: increase of 25% from lowest response value in any one or more of the following: serum M protein and/or; urine M component and/or; only in participants without measurable serum and urine M protein levels; the difference between involved and uninvolved FLC levels (absolute increase >10 milligram per deciliter [mg/dL]); Bone marrow plasma cell percentage (absolute percentage must be >10%); definite development of new bone lesions or soft tissue plasmacytomas or increase in the size of existing bone lesions/soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Measured: Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6)
Dose Expansion Phase: Progression Free Survival (PFS)
PFS: time from date of first dose until sooner of the date of PD, defined by IMWG criteria, or the date of death due to any cause, whichever occurs first. PD: increase of 25% from lowest response value in any one or more of the following: serum M protein and/or; urine M component and/or; only in participants without measurable serum and urine M protein levels; the difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL); Bone marrow plasma cell percentage (absolute percentage must be >10%); definite development of new bone lesions or soft tissue plasmacytomas or increase in the size of existing bone lesions/soft tissue plasmacytomas; development of hypercalcemia that can be attributed solely to plasma cell proliferative disorder.
Measured: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6)
Dose Expansion Phase: Time to Response (TTR)
TTR is defined as the time from first dose to the date of first documentation of response (PR or better). PR: A >=50% reduction of serum M protein and >=90% reduction in urine M-protein or <200 mg/24 hour, or >=50% decrease in uninvolved FLC. A >=50% decrease in size of soft tissue plasmacytomas present at baseline. The Kaplan-Meier method will be used to estimate the distribution of TTR for dose level and group with at least 10 participants in the safety analysis set.
Measured: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6)
Dose Expansion Phase: Overall Survival (OS)
OS is defined as the time elapsed between the date of diagnosis until death, with censoring of participants who are alive when last seen or who are lost to follow up.
Measured: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start24 Jun 2020 (estimated)
- Primary completion10 Nov 2023 (estimated)
- Study completion10 Nov 2023 (estimated)
Why it stopped: Business Decision (no enrollment)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed and/or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392648
- Sponsor's protocol ID
- TAK-573-1002
- Other IDs
- U1111-1249-1537
- Status last verified
- Jan 2026
- First submitted
- 14 May 2020
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please visit USMedInfo@tevapharm.com to make your request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label Study to Evaluate the Safety, Tolerability and Efficacy of Intravenous TAK-573 as Part of Combination Therapy in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04392648
- Acronym / sponsor ID
- TAK-573-1002
- Keywords
- Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business Decision (no enrollment)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2020 (estimated)
- Primary completion
- 10 Nov 2023 (estimated)
- Study completion
- 10 Nov 2023 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety, tolerability, and recommended phase 2 dose (RP2D) of TAK-573 when used with dexamethasone and in combination with bortezomib, pomalidomide, or cyclophosphamide, in participants with RRMM.
Detailed description
The drug that is being tested in this study is called TAK-573. The study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TAK-573 when used in combination with dexamethasone and either bortezomib, pomalidomide or cyclophosphamide in participants with RRMM.
The study will be conducted in 2 phases: Dose Escalation Phase and Dose Expansion Phase. The study will enroll approximately 135 participants (approximately 60 participants in Dose Escalation Phase and approximately 75 participants in Dose Expansion Phase). The dose escalation phase will determine the recommended dose of TAK-573 along with the combination agents for the dose expansion phase.
This multi-center trial will be conducted in the United States, Germany, France, Spain, and Canada. The overall time to participate in this study is approximately 3 years. Participants will be followed up for 30 days after the last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Escalation:TAK-573 0.1-1.5mg/kg+Bortezomib+Dexamethasone | Experimental | Drug: TAK-573, Drug: Bortezomib, Drug: DexamethasoneTAK-573 0.1 to 1.5 milligram per kilogram (mg/kg), infusion, intravenously, once, every 3 weeks in a 21-days treatment cycle, along with bortezomib 1.3 milligram per square meter (mg/m^2), injection, subcutaneously, once on Days 1, 4, 8, and 11 and dexamethasone 40 milligram (mg) (20 mg if aged more than 75 years), tablets, orally on Days 1, 8, and 15 in each 21-days treatment cycle from Cycle 1 through Cycle 8. For participants who continue beyond Cycle 8, TAK-573 will be given as an infusion, intravenously, once, every 3 weeks in a 21-days treatment cycle with dexamethasone 40 mg (20 mg if aged more than 75 years), tablets, orally from Cycle 9 through Cycle 17. |
| Escalation:TAK-573 0.05-0.75mg/kg+Pomalidomide+Dexamethasone | Experimental | Drug: TAK-573, Drug: Pomalidomide, Drug: DexamethasoneTAK-573 0.05 to 0.75 mg/kg, infusion, intravenously, once, every 4 weeks in a 28-days treatment cycle, along with pomalidomide 4 mg, capsules, orally, once daily from Days 1 through 21 and dexamethasone 40 mg (20 mg if aged more than 75 years), tablets, orally, once on Days 1, 8, 15, and 22 in each 28-days treatment cycle from Cycle 1 through Cycle 17. |
| Escalation:TAK-573 0.1-1.5mg/kg+Cyclophosphamide+Dexamethasone | Experimental | Drug: TAK-573, Drug: Cyclophosphamide, Drug: DexamethasoneTAK-573 0.1 to 1.5 mg/kg, infusion, intravenously, once, every 4 weeks in a 28-days treatment cycle, along with cyclophosphamide 300 mg/m^2, tablets, orally, once on Days 1, 8, and 15 and dexamethasone 40 mg (20 mg if aged more than 75 years), tablets, orally, once on Days 1, 8, 15, and 22 in each 28-days treatment cycle from Cycle 1 through Cycle 17. |
| Expansion: TAK-573 + Bortezomib + Dexamethasone | Experimental | Drug: TAK-573, Drug: Bortezomib, Drug: DexamethasoneTAK-573, infusion, intravenously, once, every 3 weeks in a 21-days treatment cycle, along with bortezomib 1.3 mg/m^2, injection, subcutaneously, once on Days 1, 4, 8, and 11 and dexamethasone 40 mg (20 mg if aged more than 75 years), tablets, orally, once on Days 1, 8, and 15 in each 21-days treatment cycle until disease progression, intolerable toxicity, withdrawal from study, or death (up to 3 years). The dose of TAK-573 for Dose Expansion Phase will be the RP2D and recommended dose for expansion (RAD) determined in the previous Dose Escalation Phase. |
| Expansion: TAK-573 + Pomalidomide + Dexamethasone | Experimental | Drug: TAK-573, Drug: Pomalidomide, Drug: DexamethasoneTAK-573, infusion, intravenously, once, every 4 weeks in a 28-days treatment cycle, along with pomalidomide 4 mg, capsules, orally, once daily from Days 1 through 21 and dexamethasone 40 mg (20 mg if aged more than 75 years), tablets, orally, once on Days 1, 8, 15, and 22 in each 28-days treatment cycle until disease progression, intolerable toxicity, withdrawal from study, or death (up to 3 years). The dose of TAK-573 for Dose Expansion Phase will be the RP2D and RAD determined in the previous Dose Escalation Phase. |
| Expansion: TAK-573 + Cyclophosphamide + Dexamethasone | Experimental | Drug: TAK-573, Drug: Cyclophosphamide, Drug: DexamethasoneTAK-573, infusion, intravenously, once, every 4 weeks in a 28-days treatment cycle, along with cyclophosphamide 300 mg/m^2, tablets, orally, once on Days 1, 8, and 15 and dexamethasone 40 mg (20 mg if aged more than 75 years), tablets, orally, once on Days 1, 8, 15, and 22 in each 28-days treatment cycle until disease progression, intolerable toxicity, withdrawal from study, or death (up to 3 years). The dose of TAK-573 for Dose Expansion Phase will be the RP2D and RAD determined in the previous Dose Escalation Phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Received >=2 prior lines of therapy, including treatment with lenalidomide and a proteasome inhibitor.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- With measurable disease, defined as at least 1 of the following:
- Has adequate organ function as determined by the following laboratory values:
- Has received the final dose of any of the following treatments/procedures within the specified minimum intervals before first dose of TAK-573:
Key exclusion criteria (7 listed)
- Has polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin changes (POEMS) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, solitary plasmacytoma, amyloidosis, Waldenström macroglobulinemia or IgM myeloma, lymphoplasmacytic lymphoma, or plasma cell leukemia.
- Previous intolerance to combination agent.
- For the pomalidomide expansion group only: no prior treatment with pomalidomide.
- Inability to take prophylaxis needed for combination agent (deep vein thrombosis prophylaxis for pomalidomide, antiviral prophylaxis for proteasome inhibitor).
- Who have received autologous stem cell transplant (SCT) within 60 days before first infusion of TAK-573 or participants who have received allogeneic SCT 6 months before first infusion. Graft-versus-host disease that is active or requires ongoing systemic immunosuppression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-573TAK-573 intravenous infusion. | Drug | Escalation:TAK-573 0.05-0.75mg/kg+Pomalidomide+Dexamethasone, Escalation:TAK-573 0.1-1.5mg/kg+Bortezomib+Dexamethasone, Escalation:TAK-573 0.1-1.5mg/kg+Cyclophosphamide+Dexamethasone, Expansion: TAK-573 + Bortezomib + Dexamethasone, Expansion: TAK-573 + Cyclophosphamide + Dexamethasone, Expansion: TAK-573 + Pomalidomide + Dexamethasone |
| PomalidomidePomalidomide capsules orally. | Drug | Escalation:TAK-573 0.05-0.75mg/kg+Pomalidomide+Dexamethasone, Expansion: TAK-573 + Pomalidomide + Dexamethasone |
| BortezomibBortezomib injection subcutaneously. | Drug | Escalation:TAK-573 0.1-1.5mg/kg+Bortezomib+Dexamethasone, Expansion: TAK-573 + Bortezomib + Dexamethasone |
| CyclophosphamideCyclophosphamide tablets orally. | Drug | Escalation:TAK-573 0.1-1.5mg/kg+Cyclophosphamide+Dexamethasone, Expansion: TAK-573 + Cyclophosphamide + Dexamethasone |
| DexamethasoneDexamethasone tablets orally. | Drug | Escalation:TAK-573 0.05-0.75mg/kg+Pomalidomide+Dexamethasone, Escalation:TAK-573 0.1-1.5mg/kg+Bortezomib+Dexamethasone, Escalation:TAK-573 0.1-1.5mg/kg+Cyclophosphamide+Dexamethasone, Expansion: TAK-573 + Bortezomib + Dexamethasone, Expansion: TAK-573 + Cyclophosphamide + Dexamethasone, Expansion: TAK-573 + Pomalidomide + Dexamethasone |
Primary outcome
Number of Participants who Experienced at Least one Treatment Emergent Adverse Event (TEAE)
Time frame: Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6)
Number of Participants with Clinically Significant Vital Signs Values, Clinically Significant Change From Baseline in Clinical Laboratory Values and 12-lead Electrocardiograms (ECG), and who Received any Concomitant Medications
Time frame: Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6)
Dose Expansion Phase: Overall Response Rate (ORR)
Time frame: Cycle 17 up to 3 years (Cycle length is equal to [=] 21 days in Arm 4 and is = 28 days in Arms 5 and 6)
ORR is defined as the percentage of participants who achieved confirmed partial response (PR) or better during the study as assessed with International Myeloma Working Group (IMWG) Uniform Response Criteria. PR: greater than or equal to (>=) 50 percent (%) reduction of serum M protein and >=90% reduction in urine M-protein or less than (<) 200 milligram per 24 hour (mg/24 hour), or >=50% decrease in uninvolved free light chain (FLC). At baseline, a >=50% decrease in size of soft tissue plasmacytomas is required.
17 secondary outcomes
Dose Escalation Phase, Cmax: Maximum Observed Serum Concentration for TAK-573
Time frame: Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3)
Dose Escalation Phase, Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAK-573
Time frame: Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3)
Dose Escalation Phase, AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-573
Time frame: Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3)
Dose Escalation Phase, AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-573
Time frame: Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3)
Dose Escalation Phase, Lambda (λ) z: Apparent Serum Terminal Disposition Rate Constant for TAK-573
Time frame: Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3)
Dose Escalation Phase, T1/2z: Apparent Serum Terminal Elimination Phase Half-life for TAK-573
Time frame: Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3)
Dose Escalation Phase, CL: Total Clearance After Administration for TAK-573
Time frame: Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3)
Dose Escalation Phase, Vss: Volume of Distribution at Steady State After Administration for TAK-573
Time frame: Cycles 1 and 2 Day 1: pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3)
Percentage of Participants with Positive Antidrug Antibodies (ADA) for Anti-573
Time frame: Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length is = 21 days in Arm 4 and = 28 days in Arms 5 and 6)
Dose Escalation Phase: ORR
Time frame: Up to Cycle 17 (Cycle length = 21 days in Dose Escalation Phase Arm 1 and is = 28 days in Dose Escalation Phase Arms 2 and 3)
Best Overall Response (BOR)
Time frame: Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6)
Clinical Benefit Rate (CBR)
Time frame: Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6)
Disease Control Rate (DCR)
Time frame: Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6)
Median Duration of Response (DOR)
Time frame: Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6)
Dose Expansion Phase: Progression Free Survival (PFS)
Time frame: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6)
Dose Expansion Phase: Time to Response (TTR)
Time frame: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6)
Dose Expansion Phase: Overall Survival (OS)
Time frame: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please visit USMedInfo@tevapharm.com to make your request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAK-573, Pomalidomide and Bortezomib in people with Relapsed and/or Refractory Multiple Myeloma, run by Teva Branded Pharmaceutical Products R&D LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who Experienced at Least one Treatment Emergent Adverse Event (TEAE) (time frame: Dose Escalation Phase: up to Cycle 17 (Cycle length = 21 days in Arm 1 and is = 28 days in Arms 2 and 3); Dose Expansion Phase: Cycle 17 up to 3 years (Cycle length = 21 days in Arm 4 and is = 28 days in Arms 5 and 6)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.