A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC (Tec-Dara) versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants with Relapsed or Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma10018865
- Registration Number
- NL-OMON54191
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 32
- >=18 years of age.
- Documented multiple myeloma as defined by the criteria below:
a. Multiple myeloma diagnosis according to the IMWG diagnostic criteria
b. Measurable disease at screening as defined by any of the following:
1) Serum M-protein level >=0.5 g/dL (central laboratory); or
2) Urine M-protein level >=200 mg/24 hours (central laboratory); or
3) Serum immunoglobulin free light chain >=10 mg/dL (central laboratory) and
abnormal serum immunoglobulin kappa lambda free light chain ratio.
- Received 1 to 3 prior line(s) of antimyeloma therapy (Appendix 6) including a
PI and lenalidomide.
a. Participants who have received only 1 line of prior line of antimyeloma
therapy must be lenalidomide refractory (ie, have demonstrated progressive
disease by IMWG criteria during treatment or within 60 days of completion of
lenalidomide-containing regimen). Progression on or within 60 days of the last
dose of lenalidomide given as maintenance will meet this criterion.
- Documented evidence of progressive disease based on investigator*s
determination of response by IMWG criteria on or after their last regimen.
- Have an ECOG performance status score of 0, 1, or 2 at screening and
immediately prior to the start of administration of study treatment (Appendix
7).
- Have clinical laboratory values meeting the criteria specified in the
protocol.
- Contraindications or life-threatening allergies, hypersensitivity, or
intolerance to any study drug or its excipients,
Additional exclusion criteria pertaining to specific study drugs include:
a. A participant is not eligible to receive DPd as control therapy if any of
the following are present:
1) Contraindications or life-threatening allergies, hypersensitivity, or
intolerance to pomalidomide (intolerance defined as prior therapy discontinued
due to any AE related to pomalidomide)
2) Disease that is considered refractory to pomalidomide per IMWG (progression
during treatment or within 60 days of completing treatment with pomalidomide).
b. A participant is not eligible to receive DVd as control therapy if any of
the following are present:
1) Contraindications or life-threatening allergies, hypersensitivity, or
intolerance to bortezomib (intolerance defined as prior therapy discontinued
due to any AE related to bortezomib)
2) Grade 1 peripheral neuropathy with pain or Grade >=2 peripheral neuropathy as
defined by NCI-CTCAE Version 5.0
3) Disease that is considered refractory to bortezomib per IMWG (progression
during treatment or within 60 days of completing treatment with bortezomib).
4) Received a strong CYP3A4 inducer (see Section 6.12.3.3) within 5 half-lives
prior to randomization.
c. A participant is not eligible for this study if they are refractory to both
pomalidomide and bortezomib.
- Received any prior BCMA-directed therapy.
- Has disease that is considered refractory to an anti-CD38 monoclonal antibody
per IMWG (progression during treatment or within 60 days of completing therapy
with an anti-CD38 monoclonal antibody).
- Received a cumulative dose of corticosteroids equivalent to >=140 mg of
prednisone within 14 days before randomization.
- Received a live, attenuated vaccine within 4 weeks before randomization.
- Plasma cell leukemia at the time of screening, Waldenström*s
macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly,
endocrinopathy, M-protein, and skin changes), or primary amyloid light chain
amyloidosis.
For a full list of exclusion criteria, please refer to section 5.2 of the study
protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of this study is to compare the efficacy of teclistamab<br /><br>in combination with daratumumab SC (Tec-Dara; Arm A) with that of an<br /><br>investigator*s choice of DPd or DVd (Arm B; termed DPd/DVd hereafter) as<br /><br>assessed by PFS</p><br>
- Secondary Outcome Measures
Name Time Method <p>Key secondary objectives include further comparison of efficacy as assessed by<br /><br>overall response (PR or better) rate, CR or better rate,MRD -negativity rate,<br /><br>PFS2, Overall survival, Time to next treatment and duration of response.</p><br>