Clinical trialNCT05561387RecruitingPhase 3Interventional

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

SponsorSWOG Cancer Research NetworkEnrollment510Plasma Cell Myeloma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Sikander Ailawadhi
SWOG Cancer Research Network
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

397 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Alaska Breast Care and Surgery Llc
Anchorage, Alaska, United States
Charles W. Drescher
Recruiting
Alaska Oncology and Hematology Llc
Anchorage, Alaska, United States
Charles W. Drescher
Recruiting
Alaska Women'S Cancer Care
Anchorage, Alaska, United States
Charles W. Drescher
Recruiting
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
Charles W. Drescher
Recruiting
Anchorage Oncology Centre
Anchorage, Alaska, United States
Charles W. Drescher
Recruiting
Anchorage Radiation Therapy Center
Anchorage, Alaska, United States
Charles W. Drescher
Recruiting
Katmai Oncology Group
Anchorage, Alaska, United States
Charles W. Drescher
Recruiting
Providence Alaska Medical Center
Anchorage, Alaska, United States
Charles W. Drescher
Recruiting
Cancer Center at Saint Joseph'S
Phoenix, Arizona, United States
Shahzad Siddique
Recruiting
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
Jay W. Carlson
Recruiting
Carti Cancer Center
Little Rock, Arkansas, United States
Jay W. Carlson
Recruiting
John L Mcclellan Memorial Veterans Hospital
Little Rock, Arkansas, United States
Suspended
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Samer Al Hadidi
Recruiting
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, United States
Shahzad Siddique
Recruiting
Providence Saint Joseph Medical Center/disney Family Cancer Center
Burbank, California, United States
Charles W. Drescher
Recruiting
Marshall Cancer Center
Cameron Park, California, United States
Aaron Rosenberg
Recruiting
Mercy Cancer Center - Carmichael
Carmichael, California, United States
Shahzad Siddique
Recruiting
Mercy San Juan Medical Center
Carmichael, California, United States
Shahzad Siddique
Recruiting
Mercy Cancer Center - Elk Grove
Elk Grove, California, United States
Shahzad Siddique
Recruiting
Fremont - Rideout Cancer Center
Marysville, California, United States
Aaron Rosenberg
Recruiting
Mercy Uc Davis Cancer Center
Merced, California, United States
Shahzad Siddique
Recruiting
Providence Queen of the Valley
Napa, California, United States
Charles W. Drescher
Recruiting
Mercy Cancer Center - Rocklin
Rocklin, California, United States
Shahzad Siddique
Recruiting
Mercy Cancer Center - Sacramento
Sacramento, California, United States
Shahzad Siddique
Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Aaron Rosenberg
Recruiting
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, United States
Shahzad Siddique
Recruiting
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, United States
Shahzad Siddique
Recruiting
Providence Medical Foundation - Santa Rosa
Santa Rosa, California, United States
Charles W. Drescher
Recruiting
Providence Santa Rosa Memorial Hospital
Santa Rosa, California, United States
Charles W. Drescher
Recruiting
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, United States
Aaron Rosenberg
Recruiting
Woodland Memorial Hospital
Woodland, California, United States
Shahzad Siddique
Recruiting
Rocky Mountain Regional Va Medical Center
Aurora, Colorado, United States
Jessica D. McDermott
Recruiting
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Shahzad Siddique
Recruiting
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States
Shahzad Siddique
Recruiting
Saint Francis Cancer Center
Colorado Springs, Colorado, United States
Shahzad Siddique
Recruiting
Porter Adventist Hospital
Denver, Colorado, United States
Suspended
Mercy Medical Center
Durango, Colorado, United States
Shahzad Siddique
Recruiting
Southwest Oncology Pc
Durango, Colorado, United States
Shahzad Siddique
Recruiting
Saint Anthony Hospital
Lakewood, Colorado, United States
Shahzad Siddique
Recruiting
Littleton Adventist Hospital
Littleton, Colorado, United States
Suspended

357 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Bortezomib →Daratumumab and Hyaluronidase-fihjDexamethasone →Lenalidomide →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 12 Oct 2023
Primary completion: 30 May 2031
Completion: 30 May 2031
Last update posted: 10 Jun 2026
Registered enrollment: 510
Registry id: NCT05561387

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.