A Phase 3 Randomized Study Comparing Talquetamab in Combination with Daratumumab (SC) and Pomalidomide (Tal-DP) or Talquetamab (SC) in combination with Daratumumab SC (Tal-D) versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 1 Prior Line of Therapy
- Conditions
- 10018865Multiple Myeloma
- Registration Number
- NL-OMON53729
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
- >=18 years of age.
- Documented multiple myeloma as defined: a) Multiple myeloma diagnosis
according to the International Myeloma Working Group (IMWG) diagnostic criteria
and b) Measurable disease at screening as defined by any of the following: i)
Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter
(g/dL) (central laboratory); ii) Urine M-protein level >= 200 milligram (mg)/24
hours (central laboratory); iii) Light chain multiple myeloma without
measurable M-protein in the serum or the urine: serum immunoglobulin free light
chain >= 10 milligram per deciliter (mg/dL) (central laboratory), and abnormal
serum immunoglobulin kappa lambda free light chain ratio
- Relapsed or refractory disease as defined by: i) Relapsed disease is defined
as an initial response to prior treatment, followed by confirmed progressive
disease by IMWG criteria greater than (>) 60 days after cessation of treatment;
ii) Refractory disease is defined as less than (<) 25 percent (%) reduction in
monoclonal paraprotein (M-protein) or confirmed progressive disease by IMWG
criteria during previous treatment or less than or equal to (<=) 60 days after
cessation of treatment.
- Received at least 1 prior line of antimyeloma therapy including a proteasome
inhibitor (PI) and lenalidomide. Participants who have received only 1 prior
line of antimyeloma therapy must be considered lenalidomide-refractory (that
is, have demonstrated progressive disease by IMWG criteria on or within 60 days
of completion of lenalidomide-containing regimen). Participants who have
received >=2 prior lines of antimyeloma therapy must be considered lenalidomide
exposed
- Documented evidence of progressive disease based on investigator*s
determination of response by the IMWG criteria on or after their last regimen
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of
0, 1, or 2 at screening and immediately prior to the start of administration of
study treatment
- Contraindications or life-threatening allergies, hypersensitivity, or
intolerance to study drug excipients
- Disease is considered refractory to an anti-cluster of differentiation 38
(CD38) monoclonal antibody as defined per IMWG consensus guidelines
(progression during treatment or within 60 days of completing therapy with an
anti-CD38 monoclonal antibody)
- Received prior pomalidomide therapy
- A maximum cumulative dose of corticosteroids to >=140 milligrams (mg) of
prednisone or equivalent within 14-day period before the first dose of study
drug
- Known active central nervous system (CNS) involvement or exhibits clinical
signs of meningeal involvement of multiple myeloma. If either is suspected,
negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are
required
- Plasma cell leukemia (per IMWG criteria) at the time of screening,
Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy,
M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain
amyloidosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Progression-Free Survival (PFS)<br /><br>PFS is defined as time from the date of randomization to the first<br /><br>documentation of disease progression, or death due to any cause, whichever is<br /><br>reported first.</p><br>
- Secondary Outcome Measures
Name Time Method