Clinical Trials List
2022-09-01 - 2029-12-31
Phase III
Not yet recruiting1
Recruiting5
A Phase 3 Randomized Study Comparing Talquetamab SC 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
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Trial Applicant
Johnson & Johnson
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Ching-Chan Lin 無
- Tzu-Ting Chen 無
- 王秀慈 無
- Ming-Yu Lien 無
- Che-Hung Lin 無
- Chi-Ching Chen 無
- Chen-Yuan Lin 無
- 鄭富銘 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林耘曲 無
- 林昭文 無
- MING YAO 無
- Sheng-chieh Chou 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Shih-Feng Cho 無
- 高育青 無
- Hui-Ching Wang 未分科
- 莊哲明 無
- Jeng-Shiun Du 無
- 王閔宏 無
- Yi-Chang Liu 無
- Tsung-Jang Yeh 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chia-Jen Liu 未分科
- Ting-An Lin 未分科
- Yao-Chung Liu 未分科
- 蔡淳光 無
- Hao-Yuan Wang 無
- Sheng-Hsuan Chien 未分科
- Po-Shen Ko 未分科
- 陳玟均 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
JNJ-64407564 (talquetamab)
Daratumumab
Pomalidomide
Pomalidomide
Pomalidomide
Pomalidomide
Dexamethasone
Dexamethasone
Dosage Form
Vial
Capsules
Tablets
Dosage
40mg
1800mg
1mg
2mg
3mg
4mg
2mg
4mg
Endpoints
Inclution Criteria
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) per 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
Exclusion Criteria
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
The Estimated Number of Participants
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Taiwan
15 participants
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Global
810 participants
