Overview

A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma

Status:
Recruiting
Trial end date:
2023-12-12
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to identify recommended Phase 2 doses (RP2Ds) for each treatment combination (between daratumumab plus talquetamab and teclistamab plus daratumumab with or without pomalidomide) and to characterize the safety of each RP2D for selected treatment combinations.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Antibodies
Antibodies, Monoclonal
Daratumumab
Pomalidomide
Criteria
Inclusion Criteria:

- Documented initial diagnosis of multiple myeloma according to International Myeloma
Working Group (IMWG) diagnostic criteria

- Must have either of the following: a) received at least 3 prior lines of therapy
including a proteasome inhibitor (PI) (greater than or equal to [>=] 2 cycles or 2
months of treatment) and an immunomodulatory drug (IMiD) (>=2 cycles or 2 months of
treatment) in any order during the treatment or b) disease that is double refractory
to a PI and an IMiD

- Measurable disease at screening as defined by any of the following: Serum monoclonal
protein (M-protein) level >= 1.0 grams per deciliter (g/dL) (in non- immunoglobulin G
(IgG) myeloma, an M-protein level >=0.5 g/dL); or Urine M-protein level >=200
milligram (mg)/24 hours; or 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

- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at
screening and at Cycle 1, Day 1 predose

- Women of childbearing potential must have a negative highly-sensitive serum beta-human
chorionic gonadotropin (beta-hCG) pregnancy test (less than [<] 5 international units
per milliliter [IU/mL]) at screening and a negative urine or serum pregnancy test
within 24 hours before the first dose of study drug

Exclusion Criteria:

- Treatment in the prior 3 months with an anti- cluster of differentiation 38 (CD38)
therapy (example, daratumumab), or discontinuation of a prior anti-CD38 therapy at any
time due to an adverse event related to the anti-CD38 therapy

- Live, attenuated vaccine within 4 weeks prior to the first dose of study drug unless
approved by sponsor

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

- Seropositive for hepatitis B (defined by a positive test for hepatitis B surface
antigen [HBsAg]). Participants with resolved infection must be screened using
real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV)
deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded

- Active hepatitis C infection as measured by positive hepatitis C virus- ribonucleotide
(HCV)-RNA testing. Participants with a history of Hepatitis C virus antibody
positivity must undergo HCV-RNA testing