A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC

About this trial

The primary purpose of this study is to identify the recommended phase 2 dose (RP2D\[s\]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Part 1: Have relapsed or refractory disease, have been treated with a proteasome inhibitor, immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy for the treatment of multiple myeloma (MM),and should have been treated with at least 3 prior lines of therapy, or are refractory to proteosome inhibitor, IMiD agent, and an anti-CD38-based therapy regardless of prior lines of therapy, Part 2: Have relapsed or refractory disease, have been treated with a PI, IMiD and an anti-CD38 based therapy

Must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1

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); 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; d) For participants without measurable disease in the serum, urine, or involved FLC, presence of 1 or more focus of extramedullary disease (EMD) which meets the following criteria: extramedullary plasmacytoma not contiguous with a bone lesion, at least 1 lesion >=2 centimeter [cm] (at its greatest dimension) diameter on whole body Positron Emission Tomography and Computed Tomography (PET-CT) Scans (or whole body magnetic resonance imaging [MRI] approved by sponsor), and not previously radiated (Part 2C participants are not required to have measurable disease)

Disqualifiers

Central Nervous System (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required

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

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

Prior antitumor therapy as follows, in the specified time frame 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 within 90 days [not applicable for Part 2C participants], or CD3-redirecting therapy within 21 days[not applicable for Part 2B or 2C participants])

Trial design

Design model

Sequential

Treatments tested in this trial

  • JNJ-79635322

    Drug

    JNJ-79635322 will be administered as SC injection.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Part 1: Dose EscalationExperimental treatment 1 intervention
Group B: Part 2: Dose ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part 1: Number of Participants with Dose-limiting Toxicity (DLT)

DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.

Time frame
Up to 2 years 5 months
2

Parts 1 and 2: Number of Participants with Adverse Events (AEs) by Severity

An adverse event is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.

Time frame
Up to 2 years 5 months
3

Part 2: Number of Participants with Abnormalities in Laboratory Values

Number of participants with abnormalities in laboratory values (hematology and chemistry) will be reported.

Time frame
Up to 2 Years 5 months

Secondary outcomes

1

Serum Concentration of JNJ-79635322

Serum samples will be analyzed to determine concentrations of JNJ-79635322.

Time frame
Up to 2 Years 5 months
2

Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322

Number of participants with presence of anti-drug antibodies to JNJ-79635322 will be reported.

Time frame
Up to 2 Years 5 months
3

Preliminary Anticancer Activity of JNJ-79635322 as Defined by International Myeloma Working Group (IMWG) 2016 Response Criteria

Preliminary anticancer activity of JNJ-79635322 will be assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria.

Time frame
Up to 2 Years 5 months
4

Time to Response (TTR) as Defined by IMWG 2016 Response Criteria

TTR is defined as the time between date of first dose of study drug and the first efficacy evaluation at which the participant has met all criteria for partial response (PR) or better as defined by IMWG 2016 response criteria.

Time frame
Up to 2 Years 5 months

Other outcomes

Sponsors and contacts

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