Clinical Trials in Spain / NCT04108195
Active, not recruiting
Phase 1
A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma
NCT04108195 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Multiple Myeloma
Investigational drug(s) / intervention(s)
Daratumumab: Participants will receive daratumumab.
Talquetamab: Participants will receive talquetamab.
Teclistamab: Participants will receive teclistamab.
Pomalidomide: Participants will receive pomalidomide.
Study summary
The purpose of this study is to identify recommended Phase 2 doses (RP2Ds) for each treatment combination (between daratumumab plus talquetamab and teclistamab plus daratumumab with or without pomalidomide) and to characterize the safety of each RP2D for selected treatment combinations.
Eligibility
Inclusion Criteria:
* Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
* Must have either of the following: a) received at least 3 prior lines of therapy including a proteasome inhibitor (PI) (greater than or equal to \[\>=\] 2 cycles or 2 months of treatment) and an immunomodulatory drug (IMiD) (\>=2 cycles or 2 months of treatment) in any order during the treatment or b) disease that is double refractory to a PI and an IMiD
* Measurable disease at screening as defined by any of the following: Serum monoclonal protein (M-protein) level \>=1.0 grams per deciliter (g/dL) (in non- immunoglobulin G (IgG) myeloma, an M-protein level \>=0.5 g/dL); or Urine M-protein level \>=200 milligrams (mg)/24 hours; or 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
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and at Cycle 1, Day 1 predose
* Female participants of childbearing potential must have a negative highly-sensitive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test (less than \[\<\] 5 international units per milliliter \[IU/mL\]) at screening and a negative urine or serum pregnancy test within 1 day before the first dose of study drug
Exclusion Criteria:
* Treatment in the prior 3 months with an anti- cluster of differentiation 38 (CD38) therapy (example, daratumumab), or discontinuation of a prior anti-CD38 therapy at any time due to an adverse event related to the anti-CD38 therapy
* Live, attenuated vaccine within 4 weeks prior to the first dose of study drug unless approved by sponsor
* Active Central nervous system involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
* Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]). Participants with resolved infection must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded
* Active hepatitis C infection as measured by positive hepatitis C virus- ribonucleotide (HCV)-RNA testing. Participants with a history of Hepatitis C virus antibody positivity must undergo HCV-RNA testing
Primary outcome measure(s)
- Part 1: Number of Participants With Dose Limiting Toxicity (DLT) — Up to 52 Weeks
The dose limiting toxicities are based on drug related adverse events and defined as any of the following events: hematological or non-hematological toxicity of grade 3 or higher. - Part 1: Number of Participants With Dose Limiting Toxicity by Severity — Up to 52 Weeks
The dose limiting toxicities are based on drug related adverse events and defined as any of the following events: hematological or non-hematological toxicity of grade 3 or higher. - Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — Up to 48 Weeks
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product. - Part 2: Number of Participants With Adverse Events and SAEs by Severity — Up to 48 Weeks
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product.
Trial sites (24)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | |
| City of Hope Orange County Lennar Foundation Cancer Center | Irvine | California | |
| University of California San Francisco | San Francisco | California | |
| The Blavatnik Family Chelsea Medical Center at Mount Sinai | New York | New York | |
| Mount Sinai Medical Center | New York | New York | |
| Levine Cancer Institute | Charlotte | North Carolina | |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | |
| University of Pennsylvania | Philadelphia | Pennsylvania | |
| Vanderbilt Ingram Cancer Center | Nashville | Tennessee | |
| Medical College Of Wisconsin | Milwaukee | Wisconsin | |
| Arthur J E Child Comprehensive Cancer Centre | Calgary | Alberta | |
| University Health Network UHN Princess Margaret Cancer Centre | Toronto | Ontario | |
| Universitatsklinikum Freiburg | Freiburg im Breisgau | Germany | |
| Universitaetsklinikum Hamburg Eppendorf | Hamburg | Germany | |
| Universitaetsklinikum Heidelberg | Heidelberg | Germany | |
| Universitatsklinikum Wurzburg | Würzburg | Germany | |
| VU Medisch Centrum | Amsterdam | Netherlands | |
| LUMC | Leiden | Netherlands | |
| Hosp Clinic de Barcelona | Barcelona | Spain | |
| Inst. Cat. Doncologia-H Duran I Reynals | Barcelona | Spain | |
| Germans Trias I Pujol | Barcelona | Spain | |
| Hosp Univ Fund Jimenez Diaz | Madrid | Spain | |
| Clinica Univ. de Navarra | Pamplona | Spain | |
| Hosp Clinico Univ de Salamanca | Salamanca | Spain |
On this site
📄 Darzalex (daratumumab) drug profile →More Janssen Research & Development, LLC trials in Spain
Other trials for the same condition
A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
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A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04108195 on ClinicalTrials.gov ↗ ← All trials in Spain