Overview

A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma

Status:
Not yet recruiting
Trial end date:
2024-09-21
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study is to identify the safe dose(s) of a PD-1 inhibitor in combination with talquetamab or teclistamab, and to characterize the safety and tolerability of talquetamab or teclistamab when administered in combination with a PD-1 inhibitor.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Immune Checkpoint Inhibitors
Criteria
Inclusion Criteria:

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

- Participants with relapsed or refractory disease that are not a candidate for
available therapy with established clinical benefit

- Have measurable disease at screening as defined by at least 1 of the following: a)
Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL); b)
Urine M-protein level >= 200 milligrams (mg) per 24 hours; c) Light chain multiple
myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligrams/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

Exclusion Criteria:

- Prior antitumor therapy within 21 days prior to the first dose of study treatment
(proteasome inhibitor [PI] therapy or radiotherapy within 14 days, immunomodulatory
drug (IMiD) agent therapy within 7 days, gene -modified adoptive cell therapy or
autologous stem cell transplant within 3 months)

- Prior therapy with PD-1 inhibitors, allogeneic stem cell transplant or solid organ
transplant

- Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome
(polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or
primary light chain amyloidosis

- 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

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

- Non-hematologic toxicity from prior anticancer therapy that has not resolved to
baseline levels or to Grade less than or equal to (<=) 1 (except alopecia [any grade]
or peripheral neuropathy to Grade <= 2)

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