NCT04910568 - A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma | Biotech Hunter

Enrollment

126

Participants

Timeline

Start Date

July 26, 2021

Primary Completion Date

December 10, 2025

Study Completion Date

December 10, 2025

Conditions

Multiple Myeloma

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."

Trial Locations (27)

2100

Rigshospitalet, København Ø

3002

Peter MacCallum Cancer Centre, Melbourne

3004

The Alfred Hospital, Melbourne

24127

Asst Papa Giovanni Xxiii, Bergamo

25123

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

28009

Hospital General Universitario Gregorio Marañon, Madrid

48201

Karmanos Cancer Institute., Detroit

63110

Washington University School of Medicine, St Louis

75475

Hôpital Saint-Louis, Paris

80218

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

86021

CHU de Poitiers - La Miletrie, Poitiers

91010

City of Hope, Duarte

92618

City of Hope - Lennar Foundation Cancer Center, Irvine

3109601

Rambam Medical Center, Haifa

T6G 1Z2

Cross Cancer Institute, Edmonton

L8V 5C2

Hamilton Health Sciences, Hamilton

M5G 2M9

University Health Network, Toronto

708 52

Fakultni Nemocnice Ostrava, Ostrava

990-9585

Yamagata University Hospital, Yamagata

80-214

Uniwersyteckie Centrum Kliniczne, Gda?sk

41-500

Pratia Onkologia Katowice, Katowice

60-569

Uniwersytecki Szpital Kliniczny w Poznaniu, Późna

03080

Seoul National University Hospital, Seoul

06351

Samsung Medical Center, Seoul

08035

Hospital Universitari Vall d'Hebron, Barcelona

W1T 7HA

University College London Hospitals NHS Foundation Trust, London

SW3 6JJ

Royal Marsden Hospital, Sutton