A Randomized, Open-label, Multicenter, Multiphase Study of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, Administered in Combination with Daratumumab, Compared with Daratumumab Alone in Subjects with Relapsed or Refractory Multiple Myeloma.
- Conditions
- Relapsed or Refractory Multiple Myeloma (MM).MedDRA version: 20.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-002611-34-FR
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 386
Each potential subject must satisfy all of the following criteria to be enrolled in the study.
1. At least 18 years of age.
2. Have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) in any order during the course of treatment for multiple myeloma or have disease that is refractory to both a PI and an IMiD. (For subjects who have received more than 1 type of PI, their disease must be refractory to the most recent one.Similarly, for those who have received more than 1 type of IMiD, their disease must be refractory to the most recent one).
3. Evidence of a response to at least 1 prior treatment regimen.
4. Documented measurable disease for multiple myeloma at screening as defined by the criteria below:
-IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level =1.0 g/dL or urine M-protein level =200 mg/24 hours; or
-IgA, IgM, IgD, or IgE multiple myeloma: serum M-protein level =0.5 g/dL or urine M-protein level =200 mg/24 hours; or
-Light chain multiple myeloma without measurable disease in the serum or urine: Serum immunoglobulin free light chain =10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
5. Have relapsed or refractory disease at time of enrollment as defined below:
•Relapsed disease is defined as an initial response to previous treatment, followed by progressive disease (PD) by International Myeloma Working Group (IMWG) criteria >60 days after cessation of treatment.
•Refractory disease is defined as <25% reduction in M-protein or PD by IMWG criteria during previous treatment or =60 days after cessation of treatment.
6. Eastern Cooperative Oncology Group Performance Status (ECOG)performance status score of 0, 1, or 2.
7. Adequate organ function (bone marrow, liver, renal)
8. Willing and able to adhere to the prohibitions and restrictions specified in this protocol.
9. Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 154
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 232
Any potential subject who meets any of the following criteria will be excluded from the study:
1. Received any of Anti-CD38 antibody, including daratumumab or Anti-PD-1 and anti-PD-L1 antibodies in the past.
2. Clinically significant cardiac or pulmonary disease.
3. Prior diagnosis of autoimmune disease with the exception of subjects:
- With autoimmune thyroid disease or type 1 diabetes that is well controlled on a stable medication regimen
- With vitiligo, alopecia, or resolved childhood asthma/atopy
- With psoriasis not requiring systemic therapy
- With transient autoimmune manifestations of an acute infectious disease that resolved upon treatment of the infectious agent.
3. Unresolved Grade 2 or higher toxicity effects from previous treatment with immunotherapy not recovered to Grade =1 or baseline
4. Received any of the following prescribed medications or therapies within the specified period:
- Antimyeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, prior to first administration of study drug. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum of 4 days) for palliative treatment prior to first administration of study drug.
- An allogenic stem cell transplant (SCT) at any time; or autologous SCT within 12 weeks prior to first administration of study drug.
- Other investigational agent (including investigational vaccines), participation in another clinical study with therapeutic intent, or used an invasive investigational medical device within 28 days or 5 pharmacokinetic half-lives of the investigational agent (whichever is longer) prior to first administration of study drug.
- Systemic radiotherapy within 14 days prior to first administration of study drug.
5. Plans to undergo a stem cell transplant prior to progression of disease on this study.
6. History of malignancy (other than multiple myeloma) within 2 years prior to first administration of study drug
7. Known or suspected of not being able to comply with the study protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method