A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma (MonumenTAL-2)

Last Updated   March 27, 2024 - 21:08

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OVERVIEW

  • Gender
    all
  • Age
    18+ years
  • Phase
    phase 1
    Researchers test a new drug or treatment in a small group of people for the first time to gather information on its safety, dosing, and side effects.
  • Sites
    31 sites
  • Status
    Recruiting

SUMMARY

The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.

CONDITIONS

  • Multiple Myeloma

ELIGIBILITY

Inclusion Criteria:

* Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria

* Have measurable disease at screening as defined by at least 1 of the following: a. Serum monoclonal protein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or b. Urine M-protein level >= 200 milligrams (mg)/24 hours; or c. Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio

* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening and immediately before the start of study treatment administration

* A woman of childbearing potential must have a negative highly sensitive serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration

* Be willing and able to adhere to the lifestyle restrictions specified in the protocol, including adherence to the applicable immunomodulatory drug (IMiD) global Pregnancy Prevention Plan (PPP) or local PPP/Risk Evaluation and Mitigation Strategy (REMS) program

Exclusion Criteria:

* Live, attenuated vaccine within 4 weeks before the first dose of study treatment

* Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within the 14-day period before the start of study treatment administration

* Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required

* Known to be seropositive for human immunodeficiency virus

* History of stroke or seizure within 6 months prior to the first dose of study treatment

DETAILS

LOCATIONS

Locations in:
United States, United Kingdom, Netherlands, France, Belgium, Australia
Country (6) City or Province (31) Status
United States Atlanta, GA Emory University
RECRUITING
United States Birmingham, AL University of Alabama Birmingham
RECRUITING
United States Charlotte, NC Levine Cancer Institute
RECRUITING
United States Denver, CO Colorado Blood Cancer Institute
RECRUITING
United States Hackensack, NJ Hackensack University Medical Center
RECRUITING
United States Indianapolis, IN Indiana University
RECRUITING
United States Milwaukee, WI Medical College Of Wisconsin
RECRUITING
United States Nashville, TN Tennessee Oncology
RECRUITING
United States New York, NY Mt. Sinai School of Medicine
RECRUITING
United States New York, NY Weill Cornell Medical College
RECRUITING
United States Pittsburgh, PA University of Pittsburgh Medical Center
RECRUITING
United States San Francisco, CA University of California San Francisco
RECRUITING
United Kingdom London University College Hospital London
RECRUITING
United Kingdom Manchester The Christie Nhs Foundation Trust
RECRUITING
United Kingdom Oxford, OXF Churchill Hospital
RECRUITING
United Kingdom Surrey The Royal Marsden NHS Trust Sutton
RECRUITING
Netherlands Groningen, GR UMCG
RECRUITING
Netherlands Maastricht, LI Maastricht University Medical Centre
RECRUITING
Netherlands Utrecht, UT UMCU
RECRUITING
France Nantes Cedex 1 CHU Nantes
RECRUITING
France Pessac cedex CHU de Bordeaux - Hospital Haut-Leveque
RECRUITING
France Rennes Chu Rennes Hopital Pontchaillou
RECRUITING
France TOULOUSE Cedex 9 Institut Universitaire du cancer de Toulouse-Oncopole
RECRUITING
Belgium Brussel, BRU Cliniques Universitaires St-Luc
COMPLETED
Belgium Edegem UZA
RECRUITING
Belgium Gent UZ Gent
RECRUITING
Belgium Leuven UZ Leuven
RECRUITING
Australia Fitzroy, VIC St. Vincent's Hospital Melbourne
RECRUITING
Australia Melbourne, VIC Alfred Health
RECRUITING
Australia Southport, QLD Gold Coast University Hospital
RECRUITING
Australia Wollongong, NSW Wollongong Hospital
RECRUITING
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50

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10

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5

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Corresponds to individual site.

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