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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have previously untreated multiple myeloma (MM) as defined by the IMWG criteria requiring treatment according to the investigator
Eastern Cooperative Oncology Group (ECOG) performance status score less than or equal to (<=) 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a new drug, TAK-079, for people with multiple myeloma who have already tried other treatments. The goal is to find the best dose of the new drug to give people, and to see how well it works and how safe it is.
Who is the study for?
This trial is for adults with newly diagnosed Multiple Myeloma who have measurable disease, can take blood clot prevention meds if on lenalidomide, and have a life expectancy over 3 months. They must not have had prior MM therapy (except certain cases), recent major surgery or radiation, other clinical trials within 4 weeks, severe allergies to study drugs, active infections or certain other cancers.Check my eligibility
What is being tested?
The trial tests the safety and optimal dose of TAK-079 combined with standard myeloma treatments like Lenalidomide and Dexamethasone. It also offers continued access to TAK-079 for those previously in related studies and assesses long-term safety.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drug components, potential impact on organ function due to the disease's nature or treatment complications. Specific side effects of TAK-079 are not listed but may be similar to those of immunotherapies such as fatigue or infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have multiple myeloma needing treatment, as per IMWG criteria, and haven't been treated yet.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I was previously treated with TAK-079 in a Takeda study and the study is closed or about to close.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety Extension Phase: Number of Participants Reporting one or More Serious Adverse Events (SAEs)
Safety Extension Phase: Number of Participants Who Require Dose Modification
Safety Extension Phase: Number of Participants With Grade 3 or Higher Treatment-emergent Adverse Events (TEAEs)
+2 moreSecondary outcome measures
Treatment Phase: Number of Participants Reporting one or More TEAEs and SAEs
Treatment Phase: Number of Participants With AEs Leading to On-study Deaths
Treatment Phase: Number of Participants With Grade 3 or Higher TEAEs
+2 moreSide effects data
From 2022 Phase 2 trial • 36 Patients • NCT0415980517%
Pyrexia
8%
Depression
8%
Diplopia
8%
Atrioventricular block first degree
8%
Suicidal ideation
8%
Malaise
8%
Conjunctivitis allergic
8%
Dysarthria
8%
Dyspnoea exertional
8%
Fatigue
8%
Injection site pain
8%
Muscular weakness
8%
Paraesthesia
8%
Influenza like illness
8%
Lymphocyte count decreased
8%
Myasthenia gravis
8%
Parosmia
8%
Periorbital oedema
8%
Visual impairment
100%
80%
60%
40%
20%
0%
Study treatment Arm
TAK-079 Placebo-matching
TAK-079 300 mg
TAK-079 600 mg
Trial Design
3Treatment groups
Experimental Treatment
Group I: Treatment Phase: TAK-079 and VRdExperimental Treatment5 Interventions
TAK-079 subcutaneously, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter, along with bortezomib, subcutaneously, once on Days 1, 8, and 15, for a maximum of 8 cycles, lenalidomide, orally, once daily for 21 days, and dexamethasone, orally or intravenously, once on Days 1, 8, 15 and 22 in each 28-day treatment until PD or unacceptable toxicity, withdrawal of consent, death, or termination of the study by sponsor for up to 2 years. The dosage of dexamethasone can be reduced for participants who are >75 years, have poorly controlled diabetes, or had prior intolerance to or AE from corticosteroid therapy.
Group II: Treatment Phase: TAK-079 and LenDexExperimental Treatment4 Interventions
TAK-079, subcutaneously, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter, along with lenalidomide, orally, once daily for 21 days and dexamethasone, orally or intravenously, once on Days 1, 8, 15 and 22 in each 28-day treatment until progressive disease (PD) or unacceptable toxicity, withdrawal of consent, death, or termination of the study by sponsor for up to 2 years. The dosage of dexamethasone can be reduced for participants who are greater than (>) 75 years, have poorly controlled diabetes, or had prior intolerance to or AE from corticosteroid therapy.
Group III: Safety Extension Phase: TAK-079 and, if applicable, backbone therapy (LenDex, VRd, or PomDex)Experimental Treatment5 Interventions
TAK-079 dosing and, if applicable, backbone therapy will be administered as per the schedule outlined in the parent study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
FDA approved
Mezagitamab
Not yet FDA approved
Dexamethasone
FDA approved
Pomalidomide
FDA approved
Bortezomib
FDA approved
Find a Location
Who is running the clinical trial?
TakedaLead Sponsor
1,208 Previous Clinical Trials
4,187,867 Total Patients Enrolled
50 Trials studying Multiple Myeloma
18,183 Patients Enrolled for Multiple Myeloma
Study DirectorStudy DirectorTakeda
1,221 Previous Clinical Trials
499,924 Total Patients Enrolled
25 Trials studying Multiple Myeloma
7,480 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's electrical activity, as shown on a test called an ECG, should not have a specific measurement (QTcF) higher than 470 milliseconds. If the machine shows a higher value, a qualified person should double-check it on another test.I haven't needed strong antibiotics for a serious infection in the last 14 days.I am not allergic to the medication TAK-079 or its components.You have a positive test for HIV, hepatitis B, or hepatitis C in your blood.I have been diagnosed with a specific blood or bone marrow condition.My multiple myeloma shows signs of affecting the lining of my brain.I can take blood thinners while on lenalidomide as advised.I can take care of myself but might not be able to do heavy physical work.I have not had plasmapheresis in the last 28 days.I have multiple myeloma needing treatment, as per IMWG criteria, and haven't been treated yet.I am a suitable candidate for specific myeloma treatments as decided by my doctor.I am not currently in another study or haven't been in one for the last 4 weeks.I have a history of cancer, but it's either been in remission for 2 years, was a minor skin cancer, cervical, bladder, prostate (not aggressive or stable), breast (in situ and fully removed), or thyroid cancer that was treated.I was disqualified from the main study due to not meeting its treatment criteria.I was previously treated with TAK-079 in a Takeda study and the study is closed or about to close.You are expected to live for more than 3 months.I haven't had radiation therapy in the last 14 days, except for pain treatment.I have not had major surgery in the last 4 weeks and have recovered from any surgery-related issues.You must have a certain amount of abnormal proteins in your blood or urine as measured by specific tests.I have had treatment for multiple myeloma, but not including bisphosphonates or a single course of steroids.I am not eligible if my cancer's progress can only be measured by plasmacytoma.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Phase: TAK-079 and LenDex
- Group 2: Safety Extension Phase: TAK-079 and, if applicable, backbone therapy (LenDex, VRd, or PomDex)
- Group 3: Treatment Phase: TAK-079 and VRd
Awards:
This trial has 2 awards, including:- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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