A Platform Study Evaluating the Safety and Efficacy of Multiple Treatments in Patients With Multiple Myeloma

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosed with MM per International Myeloma Working Group (IMWG) criteria

• Eastern Cooperative Oncology Group Performance Status of 0, or 1, or 2

• Resolution of AEs from prior anti-cancer therapy to Grade \<=1

• Agreement to undergo scheduled assessments and procedures

⁃ Additional Inclusion Criteria for SS2:

• Completion of planned induction therapy and achievement of at least a partial response (PR)

• Autologous Stem Cell Transplant (SCT) within 100 days prior to first study treatment and the absence of progressive disease

• Cytogenetic high-risk features at diagnosis

• Treatment with any investigational medicinal products, systemic cancer therapies, immunotherapies received previously in CO43923 (any arms) within 5 half-lives or 3 weeks whichever is the shortest

• Agreement to comply with all local requirements of the lenalidomide risk minimization plan, which includes the global pregnancy prevention program

• For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception

• For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom even if they have had a prior vasectomy, and agreement to refrain from donating sperm

⁃ Additional Inclusion Criteria for SS4:

• Previously exposed to at least a PI, an IMiD, and an anti-CD38 antibody for the treatment of R/R MM for whom no suitable SOC therapy options are available

Locations
Other Locations
Australia
St Vincent's Hospital Melbourne
RECRUITING
Fitzroy
Prince of Wales Hospital
RECRUITING
Randwick
France
CHU Lyon Sud - Service Hématologie
RECRUITING
Pierre-bénite
IUCT Oncopole
RECRUITING
Toulouse
Hopital Bretonneau
RECRUITING
Tours
IGR
WITHDRAWN
Villejuif
Germany
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
RECRUITING
Hamburg
Universitätsklinikum Leipzig - Klinik und Poliklinik für Hämatologie
RECRUITING
Leipzig
Poland
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gda?sk
Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
RECRUITING
Olsztyn
Uniwersytecki Szpital Kliniczny w Poznaniu
RECRUITING
Późna
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Spain
Hospital Universitari Germans Trias i Pujol
RECRUITING
Badalona
Fundacion Jimenez Diaz
RECRUITING
Madrid
Hospital Clinico Universitario de Valencia
RECRUITING
Valencia
Contact Information
Primary
Reference Study ID Number: CO43923 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date: 2023-11-14
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 200
Treatments
Experimental: Substudy 2: Dose Escalation and Expansion
In the pre-phase, participants will receive 2 step-up doses and a target dose of cevostamab. The step-up dose will be given on Day(D)1 and D4. The target dose will be given on D8. Subsequently the target dose will be administered on D1 and D15 for cycles 1-6 and D1 of cycle 7 onwards. Each cycle is 28 days. Lenalidomide will be administered by mouth (PO) on a 28-day cycle.~During the dose expansion phase, cevostamab will be administered following the same dosing schedule as the dose escalation phase. The target dose will be determined after the escalation phase. Lenalidomide will be administered PO on a 28-day cycle.~Enrollment for Substudy 2 has closed.
Experimental: Substudy 4: Dose Escalation and Expansion
In the pre-phase, participants will receive 2 step-up doses and a target dose of cevostamab. The step-up dose will be given on D1 and D4. The target dose will be given on D8. Subsequently the target dose will be administered on D1 of each cycle, every 3 weeks (Q3W). Each cycle is 21 days. Iberdomide will be administered PO on a 21-day cycle.~During the dose expansion phase, cevostamab will be administered following the same dosing schedule as the dose escalation phase. The target dose will be determined after the escalation phase. Iberdomide will be administered PO on a 21-day cycle.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov