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An Open-Label, Multicenter, Phase Ib Trial Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab as Monotherapy and Cevostamab Plus Pomalidomide and Dexamethasone or Cevostamab Plus Daratumumab and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Who is this study for? Adult patients with Multiple Myeloma
What treatments are being studied? Cevostamab
Status: Recruiting
Location: See all (32) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This Phase Ib, multicenter, open-label study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of cevostamab monotherapy, cevostamab plus pomalidomide and dexamethasone (Pd) or cevostamab plus daratumumab and dexamethasone (Dd) which will be administered to participants with relapsed or refractory multiple myeloma (R/R MM) via intravenous (IV) infusion.

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

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

• Life expectancy of at least 12 weeks

• Agreement to provide bone marrow biopsy and aspirate samples

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

• Measurable disease

• For women of childbearing potential: agreement to remain abstinent or use contraception, during the treatment period (including treatment interruptions) and for at least 5 months after the last dose of cevostamab and at least 3 months after the last dose of tocilizumab was administered

• For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, during the treatment period, and for at least 2 months after the last dose of tocilizumab was administered to avoid exposing the embryo and sexual partner Additional Arm A-Specific Inclusion Criteria

• Diagnosis of R/R MM for which no established therapy for MM is appropriate and available, or intolerance to those established therapies Additional Arm B-Specific Inclusion Criteria

• For Cohort B1S: Participants with R/R MM who have received at least two prior lines of treatment, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD)

• For Cohort B2S, B1E, B3E: Participants with R/R MM who have received at least one prior line of treatment that included at least two consecutive cycles of treatment, including a PI and an IMiD

• For Cohort B4E: Participants with R/R MM who have received one to four lines of prior therapy that included at least two consecutive cycles of anti-CD38 therapy, lenalidomide and a PI, and either: Prior B-cell maturation antigen- (BCMA)-targeted therapy-directed chimeric antigen receptor T (CAR T) cell therapy or Prior BCMA-antibody-drug conjugate (ADC) therapy

• Agreement to comply with all requirements of the pomalidomide pregnancy prevention program

• For women of childbearing potential: agreement to remain abstinent or use two reliable methods of contraception starting at least 4 weeks prior to, during the treatment period, and for at least 4 weeks after the last dose of pomalidomide was administered

• For men: agreement to remain abstinent or use a condom during the treatment period and for at least 4 weeks after the last dose of pomalidomide, (even if he has undergone a successful vasectomy) and agreement to refrain from donating sperm and blood during this same period Additional Arm C-Specific Inclusion Criteria

• For Cohort C1S: Patients with R/R MM who have received at least two prior lines of treatment including a PI and an IMiD

• For Cohort C2S and additional cohorts: Participants with R/R MM who have received at least 1 prior line of therapy

• For women of childbearing potential: agreement to remain abstinent or use contraceptive methods during the treatment period and for at least 102 days after the last dose of daratumumab was administered

• For men: agreement to remain abstinent or use a condom during the treatment period and for at least 102 days after the last dose of daratumumab was administered to avoid exposing the embryo, and agreement to refrain from donating sperm during this same period

Locations
United States
California
City of Hope
ACTIVE_NOT_RECRUITING
Duarte
City of Hope - Lennar Foundation Cancer Center
ACTIVE_NOT_RECRUITING
Irvine
Colorado
Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center
RECRUITING
Denver
Georgia
Winship Cancer Institute
WITHDRAWN
Atlanta
Michigan
Karmanos Cancer Institute.
COMPLETED
Detroit
Missouri
Washington University School of Medicine
ACTIVE_NOT_RECRUITING
St Louis
Other Locations
Australia
Peter MacCallum Cancer Centre
ACTIVE_NOT_RECRUITING
Melbourne
The Alfred Hospital
RECRUITING
Melbourne
Canada
Cross Cancer Institute
ACTIVE_NOT_RECRUITING
Edmonton
Hamilton Health Sciences
ACTIVE_NOT_RECRUITING
Hamilton
University Health Network
ACTIVE_NOT_RECRUITING
Toronto
Denmark
Rigshospitalet
ACTIVE_NOT_RECRUITING
København Ø
France
Hôpital Saint-Louis
WITHDRAWN
Paris
CHU de Poitiers - La Miletrie
ACTIVE_NOT_RECRUITING
Poitiers
CHU Pontchaillou
WITHDRAWN
Rennes
Israel
Rambam Medical Center
ACTIVE_NOT_RECRUITING
Haifa
Sourasky Medical Centre
RECRUITING
Tel Aviv
Italy
Asst Papa Giovanni Xxiii
ACTIVE_NOT_RECRUITING
Bergamo
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
COMPLETED
Brescia
Japan
Nagoya City University Hospital
WITHDRAWN
Aichi
National Hospital Organization Okayama Medical Center
WITHDRAWN
Okayama
The Cancer Institute Hospital of JFCR
WITHDRAWN
Tokyo
Yamagata University Hospital
ACTIVE_NOT_RECRUITING
Yamagata
Poland
Uniwersyteckie Centrum Kliniczne
WITHDRAWN
Gdansk
Pratia Onkologia Katowice
ACTIVE_NOT_RECRUITING
Katowice
Uniwersytecki Szpital Kliniczny w Poznaniu
WITHDRAWN
Późna
Republic of Korea
Samsung Medical Center
ACTIVE_NOT_RECRUITING
Seoul
Seoul National University Hospital
ACTIVE_NOT_RECRUITING
Seoul
Spain
Hospital Universitari Vall d'Hebron
ACTIVE_NOT_RECRUITING
Barcelona
Hospital General Universitario Gregorio Marañon
ACTIVE_NOT_RECRUITING
Madrid
United Kingdom
University College London Hospitals NHS Foundation Trust
ACTIVE_NOT_RECRUITING
London
Royal Marsden Hospital
ACTIVE_NOT_RECRUITING
Sutton
Contact Information
Primary
Reference Study ID Number: GO42552 https://forpatients.roche.com/No attachments to email below.
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date: 2021-07-26
Estimated Completion Date: 2028-12-21
Participants
Target number of participants: 186
Treatments
Experimental: Single-Agent Cevostamab (Arm A)
Cohort A1S is a safety run-in arm evaluating cevostamab administered in 28-day cycles on a modified weekly schedule.~Cohort A1E, an expansion cohort, has been opened and finished enrolling participants. Participants will be treated with single-agent cevostamab administered in 28-day cycles on a modified weekly schedule.
Experimental: Cevostamab plus Pomalidomide and Dexamethasone (Pd) (Arm B)
Participants will be treated with cevostamab monotherapy during a 14-day period prior to the start of pomalidomide treatment (cevostamab pre-phase).~Cohort B1S is a safety run-in arm evaluating cevostamab and Pd administered in 28-day cycles every 2 weeks (Q2W) followed by every 4 weeks (Q4W) schedule. Additional safety run-in cohort(s) with lower target dose levels of cevostamab may be opened prior to opening the expansion cohorts.~Two target dose levels of target dose level 1 (DL1) and lower dose level -1 (DL-1) of cevostamab will be selected for randomization in expansion cohorts (Cohorts B1E and B3E). An additional non-randomized expansion cohort (Cohort B4E) will be included. Expansion cohorts will follow the same Q2W/Q4W dosing schedule as Cohort B1S.
Experimental: Cevostamab plus Daratumumab and Dexamethasone (Dd) (Arm C)
Cohort C1S is a safety run-in arm evaluating cevostamab and Dd administered in 21 day cycles from Cycle(C)1 - C8 every 3 weeks (Q3W) and 28-day cycles from C9 onwards Q4W. Additional safety run-in cohort(s) with lower target dose levels of cevostamab may be opened prior to opening the expansion cohorts.~Two target dose levels of DL1 and DL-1 of cevostamab will be selected for randomization in expansion cohorts. Expansion cohorts will follow the same Q3W/Q4W dosing schedule as Cohort C1S.
Related Therapeutic Areas
Sponsors
Collaborators: Hoffmann-La Roche
Leads: Genentech, Inc.

This content was sourced from clinicaltrials.gov

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