NCT05561387 · SWOG Cancer Research Network
Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment
What this study is about
This phase III trial compares three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, and functional status.
View original scientific description
This phase III trial compares three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, and functional status.
Interventions
DRUG
Bortezomib
Given SC
DRUG
Daratumumab and Hyaluronidase-fihj
Given SC
DRUG
Dexamethasone
Given PO
DRUG
Lenalidomide
Given PO
OTHER
Quality-of-Life Assessment
Ancillary studies
OTHER
Questionnaire Administration
Ancillary studies
Primary outcome measures
Progression free survival (PFS) of Arm 1 versus (vs.) Arm 2
Time frame: 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
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 3
Time frame: From 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.myelomafrail
Where
- Anchorage, Alaska
- Phoenix, Arizona
- Fort Smith, Arkansas
- Little Rock, Arkansas
- Arroyo Grande, California
- Burbank, California
- Cameron Park, California
- Carmichael, California
- Elk Grove, California
- Marysville, California
- Merced, California
- Napa, California
And 278 more locations — see the full list below.
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 10, 2026 · Source of record for eligibility and locations