What is daratumumab studying for multiple myeloma?

Daratumumab is being studied in combination with other drugs to see if adding bortezomib improves outcomes for patients with newly diagnosed multiple myeloma. Researchers want to compare overall survival, disease progression, side effects, and quality of life between treatment combinations. This trial is sponsored by the ECOG-ACRIN Cancer Research Group.

Who may be eligible for this multiple myeloma clinical trial?

Adults 18 years or older with newly diagnosed multiple myeloma and an ECOG performance status of 0 to 2 may be eligible. Patients should have standard risk disease and limited prior treatment. Both men and women can participate if they meet health and safety criteria. Please review eligibility criteria for more details.

Is there any cost to participate in this multiple myeloma clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs outside of the study's care.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID04566328

Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation

Led by ECOG-ACRIN Cancer Research Group · Updated on 2026-05-15

1450

Participants Needed

649

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating treatments for adults with newly diagnosed multiple myeloma, a type of plasma cell cancer. This phase III trial compares a four-drug combination including daratumumab, bortezomib, lenalidomide, and dexamethasone to a three-drug combination without bortezomib. The study aims to find out if adding bortezomib improves overall and progression-free survival, response rates, and patient quality of life while monitoring side effects and disease markers like minimal residual disease (MRD). All participants first receive a standard induction therapy with daratumumab, lenalidomide, and dexamethasone over about 9 cycles of 28 days each. After this, patients are randomly assigned to one of two consolidation and maintenance treatments: one group receives bortezomib along with the other drugs for consolidation followed by maintenance with daratumumab and lenalidomide; the other group receives consolidation and maintenance without bortezomib. Treatments are given by subcutaneous injection or orally at specified days and cycles. Patients are followed long-term for up to 15 years after study entry. During the trial, patients undergo regular assessments including blood and urine tests, bone marrow biopsies, and imaging scans like PET/CT to measure disease status and treatment response. Patient-reported outcomes on symptoms like neuropathy and quality of life are also collected. Safety is closely monitored through adverse event reports. Follow-up visits occur every 3 months initially, then less frequently over time to track survival and health outcomes.

CONDITIONS

Brief Title

Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 years and older
Newly diagnosed multiple myeloma according to International Myeloma Working Group criteria
ECOG performance status of 0 to 2 (3 allowed if due to pain)
Registered in the RevREMS program and able to comply with its requirements
Ability to undergo diagnostic bone marrow aspirate
Standard risk multiple myeloma defined by RISS stage I or II
Measurable or evaluable disease by specific protein or bone marrow criteria
Required laboratory values within defined limits (e.g., creatinine clearance, blood counts, liver function)
No more than one cycle of prior chemotherapy and no prior daratumumab exposure
Controlled HIV, hepatitis B, and hepatitis C status as specified
No uncontrolled cardiovascular or respiratory conditions
Willingness to use anticoagulation if history of clotting events
Completion of induction therapy without progression and meeting safety labs before Step 2
Resolution of induction-related adverse events to grade 2 or less before Step 2

You will not qualify if you...

Known allergies or intolerance to corticosteroids, monoclonal antibodies, human proteins, or mammalian-derived products
Pregnant or breastfeeding women; females of childbearing potential must have negative pregnancy tests and agree to ongoing contraception
Peripheral neuropathy grade 2 or higher, or grade 1 with pain
Serious medical or psychiatric illness interfering with treatment
Moderate or severe persistent asthma within past 2 years or uncontrolled asthma
Concurrent chemotherapy or investigational therapies other than bisphosphonates
Receipt of non-protocol therapy outside assigned induction including stem cell transplant
Women who are pregnant or breastfeeding at Step 2 and related contraception requirements
Inability or unwillingness to use effective contraception or abstinence as defined during study and post-treatment periods

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Induction

Duration - Approximately 9 months

Participants receive standard induction therapy with daratumumab, lenalidomide, and dexamethasone in cycles repeated every 28 days for 9 cycles, unless disease progresses or unacceptable toxicity occurs.

Multiple visits during 9 cycles over 9 months

Consolidation

Duration - Approximately 9 months

Participants are randomized to receive one of two consolidation treatments: either bortezomib, daratumumab, lenalidomide, and dexamethasone OR daratumumab, lenalidomide, and dexamethasone. Treatment repeats every 28 days for 9 cycles in the absence of disease progression or unacceptable toxicity.

Multiple visits during 9 cycles over 9 months

Maintenance

Duration - Up to 2 years

Participants receive maintenance therapy with lenalidomide and daratumumab in repeated 28-day cycles until disease progression or unacceptable toxicity occurs.

Repeated cycles every 28 days during maintenance period

Follow-up

Duration - Up to 15 years

After completing treatment, participants are followed up regularly to monitor health outcomes and any long-term effects. Visits occur every 3 months for up to 2 years, then every 6 months for years 2 to 5, and annually up to 15 years from study entry.

Visits every 3 months for 2 years, then every 6 months for 3 years, then annually

Trial Site Locations

Total: 649 locations

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States, 98508

Suspended

Anchorage Radiation Therapy Center

Anchorage, Alaska, United States, 99504

Suspended

Alaska Breast Care and Surgery LLC