Clinical trial Recruiting at 388 sites Phase 3 Interventional

Comparing drug combinations for treating newly diagnosed multiple myeloma in patients not suitable for stem cell transplant

Official title: A Phase III Randomized Trial for Newly Diagnosed Multiple Myeloma (NDMM) Patients Considered Frail or in a Subset of "Intermediate Fit" Comparing Upfront Three-Drug Induction Regimens Followed by Double or Single-Agent Maintenance

Run by SWOG Cancer Research Network · NCT05561387 · Data updated 2026-11-12

This study is testing different combinations of three drugs to see which works best for people with newly diagnosed multiple myeloma who can't have a stem cell transplant.

More Plasma Cell Myeloma trials

Quick facts

PhasePhase 3
Study typeInterventional
SexAll
Enrollment510 (estimated)
SponsorSWOG Cancer Research Network
Research network
Drugs / interventionsdaratumumab, radiation
Locations397 sites (Anchorage, Alaska and 396 other locations)
StatusRecruiting
StartedOctober 12, 2023
Main results expectedMay 30, 2031
Study endsMay 30, 2031
Registry record updatedJune 10, 2026
Trial IDNCT05561387 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with newly diagnosed multiple myeloma who are considered frail or intermediate-fit and not suitable for stem cell transplantation.

Probably not a fit

Patients with multiple myeloma who are fit for stem cell transplantation or have advanced disease may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III trial evaluates three different three-drug induction regimens followed by maintenance therapy for patients with newly diagnosed multiple myeloma who are not candidates for stem cell transplantation. The study focuses on frail or intermediate-fit patients, assessing the effectiveness of various drug combinations including bortezomib, lenalidomide, dexamethasone, and daratumumab. The primary objectives include comparing progression-free survival and overall survival among the different treatment arms, as well as evaluating safety and quality of life. Participants will be monitored for response rates and potential complications such as venous thromboembolism.

Why it matters

Potential benefit: If successful, this study could provide more effective treatment options for frail patients with multiple myeloma, improving their survival and quality of life.

How similar studies have gone: Other studies have shown promising results with similar drug combinations in treating multiple myeloma, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.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 Criteria:

* 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.

Where it's running

  • Anchorage Associates in Radiation Medicine
    Anchorage, Alaska, United States
    Recruiting
  • Anchorage Radiation Therapy Center
    Anchorage, Alaska, United States
    Recruiting
  • Alaska Breast Care and Surgery LLC
    Anchorage, Alaska, United States
    Recruiting
  • Alaska Oncology and Hematology LLC
    Anchorage, Alaska, United States
    Recruiting
  • Alaska Women's Cancer Care
    Anchorage, Alaska, United States
    Recruiting
  • Anchorage Oncology Centre
    Anchorage, Alaska, United States
    Recruiting
Show 44 more locations
  • Katmai Oncology Group
    Anchorage, Alaska, United States
    Recruiting
  • Providence Alaska Medical Center
    Anchorage, Alaska, United States
    Recruiting
  • Cancer Center at Saint Joseph's
    Phoenix, Arizona, United States
    Recruiting
  • Mercy Hospital Fort Smith
    Fort Smith, Arkansas, United States
    Recruiting
  • CARTI Cancer Center
    Little Rock, Arkansas, United States
    Recruiting
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas, United States
    Recruiting
  • Mission Hope Medical Oncology - Arroyo Grande
    Arroyo Grande, California, United States
    Recruiting
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    Burbank, California, United States
    Recruiting
  • Marshall Cancer Center
    Cameron Park, California, United States
    Recruiting
  • Mercy Cancer Center - Carmichael
    Carmichael, California, United States
    Recruiting
  • Mercy San Juan Medical Center
    Carmichael, California, United States
    Recruiting
  • Mercy Cancer Center - Elk Grove
    Elk Grove, California, United States
    Recruiting
  • Fremont - Rideout Cancer Center
    Marysville, California, United States
    Recruiting
  • Mercy UC Davis Cancer Center
    Merced, California, United States
    Recruiting
  • Providence Queen of The Valley
    Napa, California, United States
    Recruiting
  • Mercy Cancer Center - Rocklin
    Rocklin, California, United States
    Recruiting
  • Mercy Cancer Center - Sacramento
    Sacramento, California, United States
    Recruiting
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California, United States
    Recruiting
  • Pacific Central Coast Health Center-San Luis Obispo
    San Luis Obispo, California, United States
    Recruiting
  • Mission Hope Medical Oncology - Santa Maria
    Santa Maria, California, United States
    Recruiting
  • Providence Medical Foundation - Santa Rosa
    Santa Rosa, California, United States
    Recruiting
  • Providence Santa Rosa Memorial Hospital
    Santa Rosa, California, United States
    Recruiting
  • Gene Upshaw Memorial Tahoe Forest Cancer Center
    Truckee, California, United States
    Recruiting
  • Woodland Memorial Hospital
    Woodland, California, United States
    Recruiting
  • Rocky Mountain Regional VA Medical Center
    Aurora, Colorado, United States
    Recruiting
  • Penrose-Saint Francis Healthcare
    Colorado Springs, Colorado, United States
    Recruiting
  • Rocky Mountain Cancer Centers-Penrose
    Colorado Springs, Colorado, United States
    Recruiting
  • Saint Francis Cancer Center
    Colorado Springs, Colorado, United States
    Recruiting
  • Mercy Medical Center
    Durango, Colorado, United States
    Recruiting
  • Southwest Oncology PC
    Durango, Colorado, United States
    Recruiting
  • Saint Anthony Hospital
    Lakewood, Colorado, United States
    Recruiting
  • Longmont United Hospital
    Longmont, Colorado, United States
    Recruiting
  • Saint Mary Corwin Medical Center
    Pueblo, Colorado, United States
    Recruiting
  • Smilow Cancer Hospital-Derby Care Center
    Derby, Connecticut, United States
    Recruiting
  • Smilow Cancer Hospital Care Center-Fairfield
    Fairfield, Connecticut, United States
    Recruiting
  • Smilow Cancer Hospital Care Center at Glastonbury
    Glastonbury, Connecticut, United States
    Recruiting
  • Smilow Cancer Hospital Care Center at Greenwich
    Greenwich, Connecticut, United States
    Recruiting
  • Smilow Cancer Hospital Care Center - Guilford
    Guilford, Connecticut, United States
    Recruiting
  • Smilow Cancer Hospital Care Center at Saint Francis
    Hartford, Connecticut, United States
    Recruiting
  • Smilow Cancer Center/Yale-New Haven Hospital
    New Haven, Connecticut, United States
    Recruiting
  • Yale University
    New Haven, Connecticut, United States
    Recruiting
  • Yale-New Haven Hospital North Haven Medical Center
    North Haven, Connecticut, United States
    Recruiting
  • Smilow Cancer Hospital Care Center at Long Ridge
    Stamford, Connecticut, United States
    Recruiting
  • Smilow Cancer Hospital-Torrington Care Center
    Torrington, Connecticut, United States
    Recruiting

+347 more sites. See ClinicalTrials.gov for the full list.

Study contacts

  • Principal investigator: Sikander Ailawadhi — SWOG Cancer Research Network
  • Study coordinator: Sharon Palmer
  • Email: spalmer@swog.org
  • Phone: 210-614-8808

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.