Multiple MyelomaPhase 1NCT03984097
A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM)
A Phase 1 study testing TAK-079, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Takeda at 9 sites in United States.
Trial summary
The purpose of this original study is to determine the recommended phase 2 dose (RP2D) of TAK-079 when administered to participants with NDMM in combination with the backbone treatment regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- TAK-079, Lenalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 9 sitesUnited States
- Study dates
- 29 Jul 2019to 25 Mar 2026
- 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
- Must have previously untreated multiple myeloma (MM) as defined by the IMWG criteria requiring treatment according to the investigator.
- Are appropriate candidates for either the VRd or Rd backbone antimyeloma therapy according to the investigator.
- Must have measurable disease defined by at least 1 of the following:
- Serum M-protein >=1 gram per deciliter (g/dL) (>=10 gram/liter [g/L]).
- Urine M-protein >=200 mg/24 hours.
- Serum FLC assay: involved FLC level >=10 mg/dL (>=100 milligram per liter [mg/L]) provided the serum FLC ratio is abnormal.
Show all 12Show fewer
- Participants receiving lenalidomide must be able to take concurrent prophylactic anticoagulation per standard clinical practice as directed by the investigator.
- Life expectancy >3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status score less than or equal to (<=) 2.
- Inc Criteria for Participants in the Safety/Access Cohort (only):
- Participants previously treated with TAK-079 therapy in a Takeda-sponsored TAK-079 parent study. Participants will be eligible to enter this cohort when:
- 1. The parent study is closed, planned to be closed, or has met its primary objectives.
Who cannot join
- Prior systemic therapy for MM.
- o treatment with bisphosphonates or a single course of glucocorticoids does not disqualify the participant (the maximum dose of corticosteroids should not exceed the equivalent of 160 mg [for example, 40 milligram per day (mg/d) for 4 days] of dexamethasone).
- Current participation in another interventional study, including other clinical trials with investigational agents (including investigational vaccines or investigational medical device) within 4 weeks of the first dose of TAK-079 or any agent in the backbone regimen and throughout the duration of this trial.
- Prior radiation therapy within 14 days of the first dose of TAK-079 or any backbone regimen agents.
- NOTE: Prophylactic localized ("spot") radiation for areas of pain is allowed.
- Major surgery within 4 weeks before Cycle 1 Day 1 (kyphoplasty is not considered major surgery). Participants should be fully recovered from any surgically related complications.
Show all 17Show fewer
- Plasmapheresis within 28 days of randomization.
- If plasmacytoma is the only measurable parameter for assessing disease response, participant is not eligible because of difficult response evaluation.
- Clinical signs of meningeal involvement of MM exhibited during screening.
- Serum positive for human immunodeficiency virus (HIV) or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Known severe allergic or anaphylactic reactions to human recombinant proteins or excipients used in the TAK-079 formulation or agents in the backbone regimen (lenalidomide, bortezomib, dexamethasone) as per the respective prescribing information or for TAK-079, as outlined in the current investigator's brochure (IB).
- Systemic infection requiring systemic antibiotic therapy or other serious infection within 14 days before the first dose of TAK-079 or any agent in the backbone regimen. Urinary tract infection is not considered a systemic infection.
- A 12-lead electrocardiogram (ECG) showing a QT interval corrected by Frederica's formula (QTcF) >470 milliseconds. If a machine reading is above this value, the ECG should be reviewed by a qualified reader and confirmed on a subsequent ECG.
- Diagnosis of primary amyloidosis, Waldenstrom's disease, monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM) per IMWG criteria or standard diagnostic criteria, plasma cell leukemia (according to the World Health Organization [WHO] criterion: >=20% of cells in the peripheral blood with an absolute plasma cell count of more than 2 *10^9/L), polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin changes (POEMS syndrome), myelodysplastic syndrome, or myeloproliferative syndrome.
- History of myelodysplastic syndrome or another malignancy other than MM, except for the following: any malignancy that has been in complete remission for 2 years, adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer (Gleason score <=6 without known metastatic disease and with no requirement for therapy, or requiring only hormonal therapy and stable prostate-specific antigen for >=1 year before initiation of study therapy), breast carcinoma in situ with full surgical resection, and treated medullary or papillary thyroid cancer.
- Exc Criteria for Participants in the Safety/Access Cohort
- 1. Participants meeting any of the criteria for treatment discontinuation in the parent study.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817
Alabama Oncology
Birmingham, Alabama, 35211
Levine Cancer Institute
Charlotte, North Carolina, 28204
Good Samaritan Hospital
Cincinnati, Ohio, 45220
MD Anderson Cancer Center
Houston, Texas, 77030
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Pacific Cancer Care
Monterey, California, 93940
Columbia University Medical Center
New York, New York, 10032
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: An Open-Label, Multicenter Phase 1b Study Investigating the Safety of TAK-079 in Combination With Backbone Regimens for the Treatment of Patients With Newly Diagnosed Multiple Myeloma and for Whom Stem Cell Transplantation Is Not Planned as Initial Therapy
The purpose of this original study is to determine the recommended phase 2 dose (RP2D) of TAK-079 when administered to participants with NDMM in combination with the backbone treatment regimen. The purpose of the safety/access cohort is to provide continued access to TAK-079 to participants previously enrolled to a TAK-079 parent study and to evaluate the long-term safety profile of TAK-079.
Read the detailed description
Treatment phase drug being tested in this study is called TAK-079. TAK-079 is being tested to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) when added to 1 of 2 standard backbone regimens (LenDex or VRd) with newly diagnosed NDMM for whom stem cell transplantation (SCT) is not planned as initial therapy.
The study will enroll approximately 36 participants. Participants will be non-randomly assigned to one of the two treatment groups in the original study or Treatment Phase:
- TAK-079 and LenDex
- TAK-079 and VRd
All enrolled participants will have the opportunity to complete the treatment therapy and then enter the Extension study for as long as participants continue to derive benefit. Safety Extension Phase participants who have previously received and tolerated TAK-079-based parent study will continue to the extension study. The study will also evaluate the long-term safety profile of TAK-079. Participants will continue to receive TAK-079 and, if applicable, SOC backbone therapy as per the parent study.
- Conditions
- Multiple Myeloma
- Being tested
- TAK-079, Lenalidomide, Dexamethasone, Bortezomib, Pomalidomide
- Keywords
- Drug Therapy, TAK-079, CD38, Monoclonal Antibody, Lenalidomide, Bortezomib, Pomalidomide, Velcade, Stem Cell Transplant, Neoplasms, Plasma Cell
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-079Drug
Also called Mezagitamab
TAK-079 subcutaneously.
LenalidomideDrug
Lenalidomide orally.
DexamethasoneDrug
Dexamethasone orally.
BortezomibDrug
Bortezomib subcutaneously.
PomalidomideDrug
Pomalidomide orally.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Phase: TAK-079 and LenDex | Experimental | 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. Receives: Drug: TAK-079; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Pomalidomide |
| Treatment Phase: TAK-079 and VRd | Experimental | 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. Receives: Drug: TAK-079; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Bortezomib; Drug: Pomalidomide |
| Safety Extension Phase: TAK-079 and, if applicable, backbone therapy (LenDex, VRd, or PomDex) | Experimental | TAK-079 dosing and, if applicable, backbone therapy will be administered as per the schedule outlined in the parent study. Receives: Drug: TAK-079; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Bortezomib; Drug: Pomalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Phase: RP2D of TAK-079
RP2D of TAK-079 along with lenalidomide-dexamethasone (LenDex) or TAK-079 along with bortezomib, lenalidomide, and dexamethasone (VRd) will be based on number of participants with dose limiting toxicity (DLT). DLTs will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Measured: Up to Cycle 1 (Cycle length is equal to [=] 28 days)
Safety Extension Phase: Number of Participants Reporting one or More Serious Adverse Events (SAEs)
Measured: From first dose up to 30 days after the last dose of study drug (up to 4 years)
Safety Extension Phase: Number of Participants With Grade 3 or Higher Treatment-emergent Adverse Events (TEAEs)
Adverse event (AE) Grades will be evaluated as per NCI CTCAE, version 4.03.
Measured: From first dose up to 30 days after the last dose of study drug (up to 4 years)
Safety Extension Phase: Number of Participants Who Require Dose Modification
Measured: From first dose up to 30 days after the last dose of study drug (up to 4 years)
Safety Extension Phase: Number of Participants With TEAEs Leading to Treatment Discontinuation
Measured: From first dose up to 30 days after the last dose of study drug (up to 4 years)
Secondary outcomes (5)
Treatment Phase: Overall Response Rate (ORR)
ORR based on International Myeloma Working Group (IMWG) Uniform Response Criteria, is defined as the percentage of participants who achieved a PR or better during the study. PR is defined as greater than or equal to (>=) 50 percent (%) reduction of serum M-protein, and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 milligram per 24 hours (mg/24 h). If serum and urine M protein are not measurable, >=50% decrease in difference between involved and uninvolved free light chain (FLC) levels is required in place of M protein criteria.
Measured: Up to 2 years
Treatment Phase: Number of Participants Reporting one or More TEAEs and SAEs
Measured: From first dose up to 30 days after the last dose of study drug (up to 2 years)
Treatment Phase: Number of Participants With Grade 3 or Higher TEAEs
AE Grades will be evaluated as per NCI CTCAE, version 4.03.
Measured: From first dose up to 30 days after the last dose of study drug (up to 2 years)
Treatment Phase: Number of Participants with TEAEs Leading to Treatment Discontinuation
Measured: From first dose up to 30 days after the last dose of study drug (up to 2 years)
Treatment Phase: Number of Participants With AEs Leading to On-study Deaths
Measured: From screening up to 30 days after the last dose of study drug (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start29 Jul 2019
- Primary completion25 Mar 2026
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984097
- Sponsor's protocol ID
- TAK-079-1002
- Other IDs
- U1111-1230-4820
- Status last verified
- Apr 2026
- First submitted
- 11 Jun 2019
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter Phase 1b Study Investigating the Safety of TAK-079 in Combination With Backbone Regimens for the Treatment of Patients With Newly Diagnosed Multiple Myeloma and for Whom Stem Cell Transplantation Is Not Planned as Initial Therapy
- ClinicalTrials.gov ID
- NCT03984097
- Acronym / sponsor ID
- TAK-079-1002
- Conditions
- Multiple Myeloma
- Keywords
- Drug Therapy, TAK-079, CD38, Monoclonal Antibody, Lenalidomide, Bortezomib, Pomalidomide, Velcade
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 25 Mar 2026 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 12 Jun 2019 (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 original study is to determine the recommended phase 2 dose (RP2D) of TAK-079 when administered to participants with NDMM in combination with the backbone treatment regimen. The purpose of the safety/access cohort is to provide continued access to TAK-079 to participants previously enrolled to a TAK-079 parent study and to evaluate the long-term safety profile of TAK-079.
Detailed description
Treatment phase drug being tested in this study is called TAK-079. TAK-079 is being tested to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) when added to 1 of 2 standard backbone regimens (LenDex or VRd) with newly diagnosed NDMM for whom stem cell transplantation (SCT) is not planned as initial therapy.
The study will enroll approximately 36 participants. Participants will be non-randomly assigned to one of the two treatment groups in the original study or Treatment Phase:
- TAK-079 and LenDex
- TAK-079 and VRd
All enrolled participants will have the opportunity to complete the treatment therapy and then enter the Extension study for as long as participants continue to derive benefit. Safety Extension Phase participants who have previously received and tolerated TAK-079-based parent study will continue to the extension study. The study will also evaluate the long-term safety profile of TAK-079. Participants will continue to receive TAK-079 and, if applicable, SOC backbone therapy as per the parent study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Phase: TAK-079 and LenDex | Experimental | Drug: TAK-079, Drug: Lenalidomide, Drug: Dexamethasone, Drug: PomalidomideTAK-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. |
| Treatment Phase: TAK-079 and VRd | Experimental | Drug: TAK-079, Drug: Lenalidomide, Drug: Dexamethasone, Drug: Bortezomib, Drug: PomalidomideTAK-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. |
| Safety Extension Phase: TAK-079 and, if applicable, backbone therapy (LenDex, VRd, or PomDex) | Experimental | Drug: TAK-079, Drug: Lenalidomide, Drug: Dexamethasone, Drug: Bortezomib, Drug: PomalidomideTAK-079 dosing and, if applicable, backbone therapy will be administered as per the schedule outlined in the parent study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Must have previously untreated multiple myeloma (MM) as defined by the IMWG criteria requiring treatment according to the investigator.
- Are appropriate candidates for either the VRd or Rd backbone antimyeloma therapy according to the investigator.
- Must have measurable disease defined by at least 1 of the following:
- Participants receiving lenalidomide must be able to take concurrent prophylactic anticoagulation per standard clinical practice as directed by the investigator.
- Life expectancy >3 months.
Key exclusion criteria (17 listed)
- Prior systemic therapy for MM.
- o treatment with bisphosphonates or a single course of glucocorticoids does not disqualify the participant (the maximum dose of corticosteroids should not exceed the equivalent of 160 mg [for example, 40 milligram per day (mg/d) for 4 days] of dexamethasone).
- Current participation in another interventional study, including other clinical trials with investigational agents (including investigational vaccines or investigational medical device) within 4 weeks of the first dose of TAK-079 or any agent in the backbone regimen and throughout the duration of this trial.
- Prior radiation therapy within 14 days of the first dose of TAK-079 or any backbone regimen agents.
- NOTE: Prophylactic localized ("spot") radiation for areas of pain is allowed.
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-079Also: MezagitamabTAK-079 subcutaneously. | Drug | Safety Extension Phase: TAK-079 and, if applicable, backbone therapy (LenDex, VRd, or PomDex), Treatment Phase: TAK-079 and LenDex, Treatment Phase: TAK-079 and VRd |
| LenalidomideLenalidomide orally. | Drug | Safety Extension Phase: TAK-079 and, if applicable, backbone therapy (LenDex, VRd, or PomDex), Treatment Phase: TAK-079 and LenDex, Treatment Phase: TAK-079 and VRd |
| DexamethasoneDexamethasone orally. | Drug | Safety Extension Phase: TAK-079 and, if applicable, backbone therapy (LenDex, VRd, or PomDex), Treatment Phase: TAK-079 and LenDex, Treatment Phase: TAK-079 and VRd |
| BortezomibBortezomib subcutaneously. | Drug | Safety Extension Phase: TAK-079 and, if applicable, backbone therapy (LenDex, VRd, or PomDex), Treatment Phase: TAK-079 and VRd |
| PomalidomidePomalidomide orally. | Drug | Safety Extension Phase: TAK-079 and, if applicable, backbone therapy (LenDex, VRd, or PomDex), Treatment Phase: TAK-079 and LenDex, Treatment Phase: TAK-079 and VRd |
Primary outcome
Treatment Phase: RP2D of TAK-079
Time frame: Up to Cycle 1 (Cycle length is equal to [=] 28 days)
RP2D of TAK-079 along with lenalidomide-dexamethasone (LenDex) or TAK-079 along with bortezomib, lenalidomide, and dexamethasone (VRd) will be based on number of participants with dose limiting toxicity (DLT). DLTs will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Safety Extension Phase: Number of Participants Reporting one or More Serious Adverse Events (SAEs)
Time frame: From first dose up to 30 days after the last dose of study drug (up to 4 years)
Safety Extension Phase: Number of Participants With Grade 3 or Higher Treatment-emergent Adverse Events (TEAEs)
Time frame: From first dose up to 30 days after the last dose of study drug (up to 4 years)
Adverse event (AE) Grades will be evaluated as per NCI CTCAE, version 4.03.
Safety Extension Phase: Number of Participants Who Require Dose Modification
Time frame: From first dose up to 30 days after the last dose of study drug (up to 4 years)
Safety Extension Phase: Number of Participants With TEAEs Leading to Treatment Discontinuation
Time frame: From first dose up to 30 days after the last dose of study drug (up to 4 years)
5 secondary outcomes
Treatment Phase: Overall Response Rate (ORR)
Time frame: Up to 2 years
Treatment Phase: Number of Participants Reporting one or More TEAEs and SAEs
Time frame: From first dose up to 30 days after the last dose of study drug (up to 2 years)
Treatment Phase: Number of Participants With Grade 3 or Higher TEAEs
Time frame: From first dose up to 30 days after the last dose of study drug (up to 2 years)
Treatment Phase: Number of Participants with TEAEs Leading to Treatment Discontinuation
Time frame: From first dose up to 30 days after the last dose of study drug (up to 2 years)
Treatment Phase: Number of Participants With AEs Leading to On-study Deaths
Time frame: From screening up to 30 days after the last dose of study drug (up to 2 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Related trials for Multiple Myeloma
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
RecruitingPhase 1/2
AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma
Multiple Myeloma
RecruitingPhase 1
Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Relapsed Multiple Myeloma, Refractory Multiple Myeloma
RecruitingPhase 1
A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
Multiple Myeloma (MM)
Active, not recruiting
Real World Treatment Experience of Patients With Breast, Lung, or GI Cancer or Multiple Myeloma Using Remote Symptom Monitoring
Breast Cancer, Lung Cancer
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.
Study Director study director
Takeda
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAK-079, Lenalidomide and Dexamethasone in people with Multiple Myeloma, run by Takeda at 9 sites in United States.
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 12 inclusion and 17 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: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment Phase: RP2D of TAK-079 (time frame: Up to Cycle 1 (Cycle length is equal to [=] 28 days)). The study lists 5 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 9 Apr 2026.