A Phase 1b Study of Subcutaneous Daratumumab Regimens in Combination with Bispecific T Cell Redirection Antibodies for the Treatment of Subjects with Multiple Myeloma
- Conditions
- Multiple Myeloma10018865
- Registration Number
- NL-OMON54604
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
- 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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Frequency and severity of dose-limiting toxicities<br /><br>- Frequency and severity of adverse events and serious adverse events</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Serum concentrations and pharmacodynamic markers<br /><br>- Presence of anti-drug antibodies<br /><br>- Overall response rate<br /><br>- Clinical benefit rate (minimal response or better)<br /><br>- Duration of and time to response</p><br>