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A Safety, PK and Efficacy Study of CC-92480 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

Status
Active
Cancer Type
Multiple Myeloma
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03374085
Protocol IDs
CC-92480-MM-001 (primary)
NCI-2018-00132
U1111-1205-3650
2017-001236-19
Study Sponsor
Celgene

Summary

This is an open-label, multi-center, international, Phase 1/2 study to assess the safety, PK
and efficacy of CC-92480 monotherapy and in combination with dexamethasone in subjects with
relapsed and refractory multiple myeloma (RRMM).

RRMM patient previously treated with at least 3 prior regimens including lenalidomide or
pomalidomide, a proteasome inhibitor and a CD38 antibody will be eligible.

Eligibility

  1. Subject is = 18 years of age at the time of signing the informed consent form (ICF).
  2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
  3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
  4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
  5. Subjects must have a documented diagnosis of MM and measurable disease at enrollment. Measurable disease is defined as:
  6. M-protein quantities = 0.5 g/dL by sPEP or
  7. = 200 mg/24 hour urine collection by uPEP or
  8. Serum FLC levels > 100 mg/L (milligrams/liter) involved light chain and an abnormal kappa/lambda (?/?) ratio in subjects without measurable serum or urine M-protein or
  9. For subjects with immunoglobulin class A (IgA), myeloma whose disease can only be reliably measured by quantitative immunoglobulin measurement, a serum IgA level = 0.50 g/dL.
  10. All subjects must have:
  11. Received at least 3 prior anti-myeloma regimens including at least 2 consecutive cycles of lenalidomide, pomalidomide, a proteasome inhibitor, a glucocorticoid and a CD38 antibody (note: induction with or without bone marrow transplant and with or without maintenance therapy is considered one regimen).
  12. Documented disease progression on or within 60 days from the last dose of their last myeloma therapy
  13. Subjects who had CAR-T therapy as their last myeloma therapy are eligible as long as they have documented disease progression following CAR-T therapy.
  14. In addition to criteria above (a and b), subjects enrolled in Part 2 must have disease refractory to an immunomodulatory agent (lenalidomide and/or pomalidomide), a glucocorticoid, a proteasome inhibitor, and a CD38 antibody. Refractory is defined as disease that is nonresponsive on therapy (failure to achieve minimal response or development of progressive disease), or progresses within 60 days of last dose.
  15. Subjects must have the following laboratory values:
  16. Absolute neutrophil count (ANC) = 1.25 x 109/L without growth factor support for = 7 days (= 14 days for pegfilgrastim). ANC of = 1.00 x 109/L is permitted for the dose expansion cohorts (Part 2).
  17. Hemoglobin (Hgb) = 8 g/dL.
  18. Platelets (plt) = 75 x 109/L without transfusion for = 7 days.
  19. Corrected serum calcium = 13.5 mg/dL (= 3.4 mmol/L).
  20. Creatinine clearance (CrCl) based on Cockcroft-Gault formula = 45 mL/min.
  21. AST/SGOT and ALT/SGPT = 3.0 x upper limit of normal (ULN).
  22. Serum bilirubin = 1.5 x ULN or < 3.0 mg/dL for subjects with documented Gilbert's syndrome.
  23. Uric acid = 7.5 mg/dL (446 µmol/L).
  24. PT/INR < 1.5 x ULN and partial thromboplastin time (PTT) < 1.5 x ULN, (for subjects not receiving therapeutic anticoagulation).
  25. Females of childbearing potential (FCBP) must:
  26. Have two negative pregnancy tests as verified by the Investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after discontinuation of CC-92480. This applies even if the subject practices true abstinence* from heterosexual contact.
  27. Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, two reliable forms of contraception as defined in the PPP and provided to the subject at the time of informed consent, without interruption, 28 days prior to starting CC-92480, during the study therapy (including during dose interruptions), and for 28 days after discontinuation of study therapy. Note: A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point and, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months).
  28. Male subjects must: Practice true abstinence* (which must be reviewed on a monthly basis) or agree to use of a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study (even during dose interruptions) and for at least 3 months following CC-92480 discontinuation in accordance with the PPP provided to the subject at the time of informed consent, even if he has undergone a successful vasectomy. * True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and coitus interruptus (withdrawal) are not acceptable methods of contraception.
  29. Males must agree to refrain from donating sperm while on CC-92480 for 90 days after its discontinuation. Females must agree to refrain from donating ova while on CC-92480 for 28 days after its discontinuation.
  30. All subjects must agree to refrain from donating blood while on CC-92480 and for 28 days after its discontinuation.

Treatment Sites in Georgia

Emory Clinic


1365 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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