Study to Determine Recommended Phase 2 Dose of Intravenous (IV) Eftozanermin Alfa in Combination With IV or Subcutaneous (SC) Bortezomib and Oral Dexamethasone Tablet and to Assess Change in Disease Symptoms in Adult Participants With Relapsed or Refractory Multiple Myeloma
18 Years and older, Male and Female
M20-258 (primary)
NCI-2021-06017
2020-001983-26
Summary
Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood
cells). Most trial participants with MM relapse (cancer has come back) or become non-
responsive to treatment and remission gets shorter after each line of treatment. This is a
study to determine recommended Phase 2 dose and change in disease symptoms of eftozanermin
alfa in combination with bortezomib and dexamethasone to assess how efficient the treatment
is in adult participants with relapsed/refractory (R/R) MM.
Eftozanermin alfa (ABBV-621) is an investigational drug being developed for the treatment of
R/R Multiple Myeloma (MM). Study doctors put the participants in 1 of the 2 groups, called
treatment arms. Each group receives a different treatment. Participants in one arm will
receive different doses of eftozanermin alfa in combination with bortezomib and dexamethasone
to determine phase 2 dose (RP2D). Participants in the other arm will receive eftozanermin
alfa at RP2D in combination with bortezomib and dexamethasone. Around 40 adult participants
with relapsed/refractory multiple myeloma will be enrolled at approximately 20 sites across
the world.
Participants will receive eftozanermin alfa as an infusion into the vein in combination with
bortezomib as an infusion into the vein or an injection under the skin and oral dexamethasone
tablets for 12 cycles. Each cycle is 21 days for cycles 1-8 and 35 days for cycles 9-12.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital or
clinic. The effect of the treatment will be checked by medical assessments, blood tests,
checking for side effects.
Eligibility
- Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma Working Group (IMWG) criteria.
- Has measurable disease at screening, defined by at least 1 of the following:
- Serum M-protein >= 1.0 g/dL (>= 10 g/L); OR
- Urine M-protein >= 200 mg/24 hours; OR
- Serum free light chain (sFLC) >= 10 mg/dL (100 mg/L), provided serum FLC ratio is abnormal.
- Relapsed or refractory MM after receiving at least 3, but no more than 6 prior lines of therapy, including an immunomodulatory agent (IMiD), proteasome inhibitor (PI), and an anti-CD38 antibody, and has documented disease progression that occurred during or after the most recent therapy.
- Has adequate hematologic, hepatic and renal function as defined in the protocol.
- Eastern Cooperative Oncology Group (ECOG) 0 or 1.
- Life expectancy >= 12 weeks.
**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...
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