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ACTIVE NOT RECRUITING
NCT04910568
PHASE1

A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma

Sponsor: Genentech, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2021-07-26

Completion Date

2029-12-10

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

DRUG

Cevostamab

Cevostamab will be administered intravenously on a 28-day cycle, up to a total of 13 cycles (Arm A), in 28-day cycles Q2W followed by Q4W (Arm B) and in 21 day cycles from C1-C8 Q3W and 28-day cycles from C9 onwards Q4W (Arm C). For Arm A, participants have the option to enter re-treatment after Cycle 13. For Arms B and C, participants can be treated until disease progression or unacceptable toxicity.

DRUG

Tocilizumab

Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.

DRUG

Pomalidomide

Pomalidomide will be administered orally (PO) on a 28-day cycle.

DRUG

Daratumumab

Daratumumab will be administered subcutaneously (SC) on 21 day (C1-8) and 28-day cycles (C9 onwards).

DRUG

Dexamethasone

Arm A: Dexamethasone will be administered as a premedication. Arms B and C: Dexamethasone will be administered via IV or orally at 20 mg as study investigational medicinal product.

Locations (26)

City of Hope

Duarte, California, United States

City of Hope - Lennar Foundation Cancer Center

Irvine, California, United States

Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center

Denver, Colorado, United States

Karmanos Cancer Institute.

Detroit, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Cross Cancer Institute

Edmonton, Alberta, Canada

Hamilton Health Sciences

Hamilton, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Fakultni Nemocnice Ostrava

Ostrava, Czechia

Rigshospitalet

København Ø, Denmark

Hôpital Saint-Louis

Paris, France

CHU de Poitiers - La Miletrie

Poitiers, France

Rambam Medical Center

Haifa, Israel

Asst Papa Giovanni Xxiii

Bergamo, Lombardy, Italy

A.O. Spedali Civili Di Brescia-P.O. Spedali Civili

Brescia, Lombardy, Italy

Yamagata University Hospital

Yamagata, Japan

Pratia Onkologia Katowice

Katowice, Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Późna, Poland

Seoul National University Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

University College London Hospitals NHS Foundation Trust

London, United Kingdom

Royal Marsden Hospital

Sutton, United Kingdom