Comparing Drug Combinations for Newly Diagnosed Multiple Myeloma
This study is for people with newly diagnosed multiple myeloma who are not able to have a stem cell transplant. It compares different combinations of four drugs: Bortezomib, Daratumumab and Hyaluronidase-fihj, Dexamethasone, and Lenalidomide. Bortezomib may work by blocking enzymes cancer cells need to grow. The study looks at how well these drug combinations prevent the cancer from getting worse (progression-free survival) and how long people live (overall survival). To join, you must have a confirmed diagnosis of multiple myeloma and measurable disease. The current recruitment status is unclear.
- Study design
- This study plans to enroll 510 participants and compares three different drug combinations. It is an interventional study, meaning participants will receive specific treatments.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 10 years to assess progression-free survival and overall survival.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05561387
Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment
Recruiting
PHASE3All AgesInterventionalTreatmentSWOG Cancer Research NetworkGovernment-funded
~510 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:BortezomibDaratumumab and Hyaluronidase-fihjDexamethasoneLenalidomideQuality-of-Life AssessmentQuestionnaire Administration
At a glance
Recruiting sites
388 of 397 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS) of Arm 1 versus (vs.) Arm 2
Measured over From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, or assessed up to 10 years
+1 more outcome measured
Conditions
Where it's being run
397 sites across 35 statesMichigan54
Illinois44
Minnesota44
Wisconsin25
Missouri24
Ohio20
California18
Washington18
Study leadership
- Sikander Ailawadhi · PRINCIPAL_INVESTIGATOR · SWOG Cancer Research Network
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants must have documented multiple myeloma satisfying standard International Myeloma Working Group (IMWG) diagnostic criteria within 28 days prior to registration
Participants must have measurable disease within 28 days prior to registration as defined by any of the following:
Immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein \[M-protein\] level \>= 0.5 gram/deciliter \[g/dL\] or urine M-protein level \>= 200 milligram\[mg\]/24 hours\[hrs\]); OR
IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level \>= 0.2 g/dL or urine M-protein level \>= 200 mg/24 hrs); OR
Light chain multiple myeloma (serum immunoglobulin free light chain \>= 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio)
All disease must be assessed and documented on the baseline/pre-registration tumor assessment form
Participants must have a calculated myeloma frailty index (Myeloma Frailty Score Calculator; http://www.myelomafrailtyscorecalculator.net/) categorized as frail or intermediate fit (regardless of age) within 28 days prior to registration
For Participants Meeting "Frail" Status:
Participants with any degree of kidney dysfunction are allowed; however, participants on dialysis are not eligible
For Participants Meeting "Frail" Status:
Hemoglobin \>= 7 g/dL (must be performed within 28 days prior to registration)
Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM)
For Participants Meeting "Frail" Status:
Platelets \>= 50 x 10\^9/L (must be performed within 28 days prior to registration)
Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM)
For Participants Meeting "Frail" Status:
Absolute neutrophil count (ANC) \>= 0.75 x10\^9/L (must be performed within 28 days prior to registration)
Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM)
For Participants Meeting "Intermediate Fit" Status, one or more of the following criteria must be present:
Kidney dysfunction showing calculated creatinine clearance (CrCl) \<30 ml/min.
Actual lab serum creatinine value with a minimum of 0.7 mg/dL.
Participants must have bone marrow function assessed and meet the below criteria ranges:
Hemoglobin between 7-8 g/dL, OR
Platelets between 50-75 x10\^9/L, OR
ANC between 0.75-1 x10\^9/L
Note: growth factor and transfusion utilization are allowed as long as cytopenias are considered secondary to bone marrow involvement from MM)
Revised International Staging System (R-ISS) stage III disease
Note: All labs must be performed within 28 days prior to registration
Participants must have a complete medical history and physical exam within 28 days prior to registration
Participants must have whole body imaging within 60 days prior to registration. The recommended method of imaging is a positron emission tomography/computed tomography (PET/CT); a low-dose whole body CT scan or whole-body magnetic resonance imaging (MRI) or skeletal survey should be done only if a PET/CT scan cannot be done or is non-feasible. This must be documented in the comments section of the Onstudy form.
Total bilirubin =\< 2 times institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional ULN (within 28 days prior to registration)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 × institutional ULN (within 28 days prior to registration)
Participants must have adequate cardiac function, as assessed by the treating physician within 14 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must not be assessed as class 3 or 4
Participants with known diabetes must show evidence of controlled disease within 14 days prior to registration. Uncontrolled diabetes is defined as: A glycosylated hemoglobin (Hg)A1C \> 7
Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test on the most recent test result obtained, within 6 months prior to registration
All participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration
Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, participant must have an undetectable HCV viral load within 28 days prior to registration
Participants must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status score of 0-2 (Note: Participants with ECOG/Zubrod performance score \[PS\] 3, especially where the deterioration of PS is considered secondary to the MM diagnosis, will be allowed)
Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) specimen tracking system
Participants who are able to complete the patient-reported outcomes measures in English or Spanish must agree to participate in the PRO portion of the study
Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
Exclusion
Participants must not have received any prior systemic therapy for multiple myeloma with the exception of any one or more of the following:
An emergency use of a short course of corticosteroids (equivalent of dexamethasone 160 mg) any time before registration, or
Up to one complete cycle of a non-daratumumab and hyaluronidase-fihj containing anti-myeloma regimen (1 cycle = 21 or 28 days depending on the regimen being used), or
Localized palliative radiation therapy for multiple myeloma, as long as the radiation therapy is completed at least 3 days prior to starting the systemic treatment as per the study protocol.
Participants must not have evidence of grade 4 peripheral neuropathy prior to study registration
Participants must not have uncontrolled blood pressure within 14 days prior to registration. Uncontrolled blood pressure: systolic blood pressure (SBP) \> 140 mmHg or diastolic blood pressure (DBP) \> 90 mmHg. Participants are permitted to be receiving multiple anti-hypertensive medications (unless otherwise indicated in the study). All blood pressure measurements within the 14 days prior to registration must be SBP =\< 140 and DBP =\< 90. A participant with a single blood pressure elevation who upon rechecking has a normal blood pressure will remain eligible at the discretion of the registering investigator.
Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen.
What this trial measures
- Progression free survival (PFS) of Arm 1 versus (vs.) Arm 2From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, or assessed up to 10 years
Analysis of each of the dual primary endpoints will be performed using a stratified log-rank test for comparison between arms. The analyses will be stratified according to frailty score (frail vs. intermediate fit), presence of one or more high-risk abnormalities by fluorescence in situ hybridization (iFISH) (yes vs. no), and prior therapy (yes vs. no). All eligible participants will be considered in analyses of the dual primary endpoints, according to their assigned arm at randomization.
- Overall survival (OS) of Arm 1 vs. Arm 3From date of randomization to date of death due to any cause, or assessed up to 10 years
Analysis of each of the dual primary endpoints will be performed using a stratified log-rank test for comparison between arms. The analyses will be stratified according to frailty score (frail vs. intermediate fit), presence of one or more high-risk abnormalities by iFISH (yes vs. no), and prior therapy (yes vs. no). All eligible participants will be considered in analyses of the dual primary endpoints, according to their assigned arm at randomization.