Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment

Recruiting now · Phase 3

Conditions studied: Plasma Cell Myeloma

In brief

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. Treatment for multiple myeloma includes initial treatment (induction) which is the first treatment a patient receives for cancer followed by ongoing treatment (maintenance) which is given after initial treatment to help keep the cancer from coming back. There are three combinations of four different drugs being studied. Bortezomib is one of the drugs that may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide works by helping bone marrow to produce normal blood cells and killing cancer cells. Anti-inflammatory drugs, such as dexamethasone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Daratumumab and hyaluronidase-fihj is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Patients receive 1 of 3 combinations of these drugs for treatment to determine which combination of study drugs works better to shrink and control multiple myeloma.

Key facts

Study ID

NCT05561387

Run by

SWOG Cancer Research Network

People needed

510

Starts

2023-10-12

Expected to finish

2031-05-30

Last updated by the study team

2026-06-10

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Anchorage Radiation Therapy Center — Anchorage, Alaska, United States (enrolling)
• Anchorage Associates in Radiation Medicine — Anchorage, Alaska, United States (enrolling)
• Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States (enrolling)
• Alaska Women's Cancer Care — Anchorage, Alaska, United States (enrolling)
• Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States (enrolling)
• Katmai Oncology Group — Anchorage, Alaska, United States (enrolling)
• Providence Alaska Medical Center — Anchorage, Alaska, United States (enrolling)
• Cancer Center at Saint Joseph's — Phoenix, Arizona, United States (enrolling)
• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States (enrolling)
• CARTI Cancer Center — Little Rock, Arkansas, United States (enrolling)
• Anchorage Oncology Centre — Anchorage, Alaska, United States (enrolling)
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (enrolling)
• Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California, United States (enrolling)
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States (enrolling)
• Marshall Cancer Center — Cameron Park, California, United States (enrolling)
• Mercy Cancer Center - Carmichael — Carmichael, California, United States (enrolling)
• Mercy San Juan Medical Center — Carmichael, California, United States (enrolling)
• Mercy Cancer Center - Elk Grove — Elk Grove, California, United States (enrolling)
• Fremont - Rideout Cancer Center — Marysville, California, United States (enrolling)
• Mercy UC Davis Cancer Center — Merced, California, United States (enrolling)
• Providence Queen of The Valley — Napa, California, United States (enrolling)
• Mercy Cancer Center - Rocklin — Rocklin, California, United States (enrolling)
• Mercy Cancer Center - Sacramento — Sacramento, California, United States (enrolling)
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States (enrolling)
• Pacific Central Coast Health Center-San Luis Obispo — San Luis Obispo, California, United States (enrolling)

Full record on ClinicalTrials.gov

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