A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM)

NCT03984097 | Completed Phase 1 FDA Drug

• 2 other identifiers: TAK-079-1002U1111-1230-4820
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 9

Brief 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. 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.

Conditions

Multiple Myeloma

Keywords

Drug Therapy; TAK-079; CD38; Monoclonal Antibody; Lenalidomide; Bortezomib; Pomalidomide; Velcade; Stem Cell Transplant; Neoplasms, Plasma Cell

Outcome Measures

Primary Outcomes (5)

• 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.

  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)

  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.

  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

  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

  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)

  Up to 2 years

• Treatment Phase: Number of Participants Reporting one or More TEAEs and SAEs

  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

  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

  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

  From screening up to 30 days after the last dose of study drug (up to 2 years)

Study Arms (3)

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.

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.

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.

Drug: TAK-079; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Bortezomib; Drug: Pomalidomide

Interventions

TAK-079 DRUG

TAK-079 subcutaneously.

Also known as: Mezagitamab

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

Lenalidomide DRUG

Lenalidomide orally.

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

Dexamethasone DRUG

Dexamethasone orally.

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

Bortezomib DRUG

Bortezomib subcutaneously.

Safety Extension Phase: TAK-079 and, if applicable, backbone therapy (LenDex, VRd, or PomDex); Treatment Phase: TAK-079 and VRd

Pomalidomide DRUG

Pomalidomide orally.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Inclusion (Inc) Criteria: 1. Must have previously untreated multiple myeloma (MM) as defined by the IMWG criteria requiring treatment according to the investigator. 2. Are appropriate candidates for either the VRd or Rd backbone antimyeloma therapy according to the investigator. 3. 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. 4. Participants receiving lenalidomide must be able to take concurrent prophylactic anticoagulation per standard clinical practice as directed by the investigator. 5. Life expectancy \>3 months. 6. 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. Exclusion (Exc) Criteria: 1. 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). 2. 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. 3. 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. 4. 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. 5. Plasmapheresis within 28 days of randomization. 6. If plasmacytoma is the only measurable parameter for assessing disease response, participant is not eligible because of difficult response evaluation. 7. Clinical signs of meningeal involvement of MM exhibited during screening. 8. Serum positive for human immunodeficiency virus (HIV) or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 9. 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). 10. 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. 11. 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. 12. 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. 13. 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Takeda: lead

Study Sites (9)

Alabama Oncology

Birmingham, Alabama, 35211, United States

Location

Pacific Cancer Care

Monterey, California, 93940, United States

Location

American Oncology Partners of Maryland, PA

Bethesda, Maryland, 20817, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Links

• 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.
• 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.

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Lenalidomide; Dexamethasone; Bortezomib; pomalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 12, 2019
• Study Start: July 29, 2019
• Primary Completion: March 25, 2026
• Study Completion: March 25, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (9)