Relapsed or Refractory Multiple myeloma MedDRA version: 20.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Product Name: Not yet available
Product Code: INCB001158 25 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: not yet available
Current Sponsor code: INCB001158
Other descriptive name: INCB001158
Co
Sponsors
Incyte Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ability to comprehend and willingness to sign a written ICF for the study. 2. Men or women aged 18 years or older. 3. Prior diagnosis of MM according to IMWG diagnostic criteria. 4. Has measurable disease at screening, as defined by the following: • Serum M-protein level = 1.0 g/dL, or • Urine M-protein level = 200 mg/24 hours, or • Serum Ig FLC = 10 mg/dL and abnormal serum Ig kappa to lambda FLC ratio. 5. Has received at least 3 prior lines (including PI, IMiD, and anti-CD38 therapies) but not more than 5 prior lines of MM treatment. a. Has received last dose of prior anti-CD38 therapy at least 3 months before initiation of study treatment. b. Has achieved a response (MR or better), based on investigator’s evaluation of response by IMWG criteria, to prior anti-CD38 therapy. c. Has documented evidence of PD as defined by the IMWG criteria on or after their last regimen. 6. ECOG performance status of 0 or 1. 7. Willing to avoid pregnancy or fathering children based on the criteria below: a. Woman of nonchildbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR = 12 months of amenorrhea and at least 51 years of age). b. Woman of childbearing potential who has a negative serum pregnancy test at screening and before the first dose on Day 1 and who agrees to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening until 3 months after the last dose of the last component of study treatment and must refrain from donating eggs (ova, oocytes). Permitted methods that are at least 99% effective in preventing pregnancy (see Appendix A) should be communicated to the participant and their understanding confirmed. c. Man who agrees to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening until 3 months after the last dose of the last component of study treatment and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participant and their understanding confirmed. 8. Willing to provide fresh and archival bone marrow aspiration and biopsy tissue during screening and on 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 78
Exclusion criteria
Exclusion criteria: 1. Receipt of any of the following treatment within the indicated interval before the first administration of study drug: a. Anti-myeloma treatment within 2 weeks or 5 half-lives (whichever is longer). - Exception: Washout of immune checkpoint inhibitor therapy is NOT required. b. Investigational drug (including investigational vaccines) or invasive investigational medical device within 4 weeks. c. Autologous stem cell transplant within 12 weeks, or allogeneic stem cell transplant at any time. d. Plasmapheresis within 4 weeks. e. Radiation therapy within 2 weeks. f. Major surgery within 2 weeks, or inadequate recovery from an earlier surgery, or surgery planned during the time the participant is expected to participate in the study or within 2 weeks after the last dose of study treatment. 2. Toxicity = Grade 2 from previous anti-myeloma therapy except for stable chronic toxicities (= Grade 2) not expected to resolve, such as stable Grade 2 peripheral neuropathy. 3. Known additional malignancy (other than MM) that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for > 1 year, after treatment with curative intent. 4. Known meningeal involvement of MM. 5. Participants with laboratory values at screening defined in the protocol (Table 10). 6. Significant concurrent, uncontrolled medical condition, including but not limited to the following: a. Known COPD (defined as a FEV1 470 ms is excluded. e. Inability of the participant to swallow and retain oral medication. 7. Any of the following: a. Known to be seropositive for hepatitis B (defined by a positive test for HBsAg). Participants with resolved infection (ie, participants who are HBsAg-negative but positive for antibodies to anti-HBc and/or anti-HBs) must be screened using real-time PCR measurement of HBV DNA levels. Those who are PCR-positive will be excluded. - Exception: Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination do not need to be tested for HBV DNA by PCR. b. Known to be seropositive for hepatitis C. Participants who have had definitive treatment for HCV are permitted if HCV RNA is undetectable at screening visit. c. Known to be seropositive for HIV. HIV testing is not required unless mandated by the local health authority. 8. Plasma cell leuke
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase 1: To determine the safety, tolerability, and RP2D of INCB001158 in combination with daratumumab SC. Phase 2: To compare the ORR of the RP2D of INCB001158 in combination with daratumumab SC to daratumumab SC monotherapy.;Secondary Objective: Phase 1: To determine the efficacy of INCB001158 in combination with daratumumab SC. Phase 2: To determine the safety and tolerability of INCB001158 monotherapy at RP2D, and to compare the safety and tolerability and RP2D of INCB001158 in combination with daratumumab SC to daratumumab SC monotherapy.;Primary end point(s): Phase 1: Safety and tolerability determined by monitoring the frequency, duration, and severity of AEs. Phase 2: ORR, defined as the proportion of participants with a documented response PR or better, as per IMWG criteria.;Timepoint(s) of evaluation of this end point: Safety will be monitored continuously. Efficacy/disease evaluations will be performed at each treatment cycle as specified in the schedule of activity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase 1: ORR, defined as the proportion of participants with a documented response PR or better, as per IMWG criteria. Phase 2: Safety and tolerability determined by monitoring the frequency, duration, and severity of AEs.;Timepoint(s) of evaluation of this end point: Safety will be monitored continuously. Efficacy/disease evaluations will be performed at each treatment cycle as specified in the schedule of activity. | — |
Countries
Germany, Spain, United States
Contacts
Public ContactClinical Trials Information
Incyte Corporation
Outcome results
None listed