Actively Recruiting
A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma
Led by Hoffmann-La Roche · Updated on 2026-05-04
200
Participants Needed
16
Research Sites
245 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
CO43923 is a platform study that will evaluate the safety, efficacy, and pharmacokinetics (PK) of multiple treatment combinations, as monotherapy or in combination, in participants with multiple myeloma (MM). The study is designed with the flexibility to open new treatment substudies as new treatments become available. Information regarding the opened substudies are found below.
CONDITIONS
Official Title
A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with multiple myeloma according to International Myeloma Working Group criteria
- Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
- Adverse events from prior anti-cancer therapy resolved to Grade 1 or lower
- Willing to undergo scheduled assessments and procedures
- For Substudy 2: Completed planned induction therapy with at least partial response
- For Substudy 2: Received autologous stem cell transplant within 100 days before first study treatment without disease progression
- For Substudy 2: Have high-risk cytogenetic features at diagnosis
- For Substudy 2: Prior treatment with investigational drugs or cancer therapies within 5 half-lives or 3 weeks (whichever is shorter)
- For Substudy 2: Agree to comply with lenalidomide risk minimization plan including pregnancy prevention
- For female participants of childbearing potential: Agree to abstain or use contraception
- For male participants: Agree to abstain or use condom and refrain from sperm donation
- For Substudy 4: Previously treated with at least a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody for relapsed/refractory multiple myeloma with no suitable standard therapy options
You will not qualify if you...
- Unable to comply with required hospitalization and procedures
- History of progressive multifocal leukoencephalopathy
- History of other malignancy within 2 years before screening
- Current or past central nervous system disease
- Significant cardiovascular disease limiting response to cytokine release syndrome
- Symptomatic active lung disease or needing supplemental oxygen
- Active infection at enrollment or recent major infection needing IV antibiotics within 14 days
- Chronic active Epstein-Barr virus infection
- Positive test for acute or chronic hepatitis B or hepatitis C infection
- Known HIV infection
- Received live attenuated vaccine within 4 weeks before study or planned during study
- Any medical condition or lab abnormality that prevents safe participation or compliance
- For Substudy 2: Allergy to lenalidomide or immunomodulatory drugs
- For Substudy 2: Lesions near vital organs that may worsen during tumor flare
- For Substudy 2: Prior investigational therapy within 5 half-lives or 3 weeks
- For Substudy 2: Active infection excluding nail fungus or recent major infection needing IV antimicrobials
- For Substudy 2: History of severe rash or blistering from immunomodulatory drugs
- Pregnant, breastfeeding, or planning pregnancy during study or within 5 months after last dose
- For both substudies: History of autoimmune disease
- For both substudies: History of hemophagocytic lymphohistiocytosis or macrophage activation syndrome
- For both substudies: Severe allergic or anaphylactic reactions to monoclonal antibody therapy
- For both substudies: Recent high-dose corticosteroids equivalent to ≥140 mg prednisone within 14 days
- For both substudies: Active symptomatic COVID-19 infection or recent treatment within 14 days
- For both substudies: Positive Epstein-Barr virus or cytomegalovirus PCR before treatment
- For Substudy 4: Recent investigational or systemic cancer therapy within specified timeframes
- For Substudy 4: History of severe allergic reactions to study drugs or excipients
- For Substudy 4: Known allergies to listed substances including boron, mannitol, corticosteroids, or monoclonal antibodies
- For Substudy 4: Use of strong CYP3A modulators or proton-pump inhibitors near study start
- For Substudy 4: Uncontrolled hypertension or diabetes within 14 days before enrollment
- For Substudy 4: Concurrent use of strong CYP3A4/5 inhibitors or inducers
- For Substudy 4: History of malignancies other than multiple myeloma unless disease-free for 5 years
- For Substudy 4: Peripheral neuropathy greater than Grade 2
- Prior treatment with cevostamab, FcRH5-targeting agents, or iberdomide
- Pregnant, breastfeeding, or planning pregnancy during study or within 5 months after last dose
- History of severe skin reactions or drug rash with systemic symptoms
- Use of systemic immunosuppressive medications
- Prior CAR T-cell therapy within 12 weeks before starting pre-phase
- Autologous stem cell transplant within 100 days before pre-phase
- Prior allogeneic stem cell transplant
- Plasmacytoma near vital organs that may worsen during tumor flare
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
2
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
3
CHU Lyon Sud - Service Hématologie
Pierre-Bénite, France, 69310
Actively Recruiting
4
IUCT Oncopole
Toulouse, France, 31059
Actively Recruiting
5
Hopital Bretonneau
Tours, France, 37044
Actively Recruiting
6
IGR
Villejuif, France, 94800
Withdrawn
7
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
Hamburg, Germany, 20246
Actively Recruiting
8
Universitätsklinikum Leipzig - Klinik und Poliklinik für Hämatologie
Leipzig, Germany, 04103
Actively Recruiting
9
Uniwersyteckie Centrum Kliniczne
Gda?sk, Poland, 80-214
Actively Recruiting
10
Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, Poland, 10-228
Actively Recruiting
11
Uniwersytecki Szpital Kliniczny w Poznaniu
Późna, Poland, 60-569
Withdrawn
12
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
13
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
14
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08915
Actively Recruiting
15
Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
16
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
Research Team
R
Reference Study ID Number: CO43923 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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