Eftozanermin Alfa + Bortezomib + Dexamethasone for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+26 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: AbbVie

No Placebo Group

Trial Summary

What is the purpose of this trial?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 Criteria

Adults with Multiple Myeloma who've had 3-6 prior treatments including specific agents, but whose cancer has returned or stopped responding to treatment. They must have measurable disease, a life expectancy of at least 12 weeks, and good heart, liver, and kidney function. Not eligible if they've had recent bortezomib therapy or certain eye surgeries, uncontrolled liver issues, high-dose steroids recently, other MM therapies too close to the trial start date or severe neuropathy.

Inclusion Criteria

I have been diagnosed with multiple myeloma according to IMWG standards.

My cancer can be measured by specific blood or urine tests.

My multiple myeloma has returned or didn't respond after 3-6 treatments including IMiD, PI, and anti-CD38.

+3 more

Exclusion Criteria

I stopped taking bortezomib because of side effects.

I haven't taken high doses of steroids recently.

I haven't received monoclonal antibodies for myeloma in the last 4 weeks.

+8 more

Participant Groups

The study is testing Eftozanermin alfa (ABBV-621) combined with Bortezomib and Dexamethasone in adults with relapsed/refractory Multiple Myeloma. Participants are divided into two groups: one receives varying doses to find the optimal Phase 2 dose; the other gets this determined dose for comparison. The drugs are given over several cycles involving IV infusions and oral tablets.

2Treatment groups

Experimental Treatment

Group I: Safety Lead-inExperimental Treatment3 Interventions

Participants will receive escalating doses of eftozanermin alfa in combination with bortezomib and dexamethasone to determine recommended phase 2 dose (RP2D).

Group II: Dose ExpansionExperimental Treatment3 Interventions

Participants will receive eftozanermin alfa at RP2D determined in Safety Lead-in part in combination with bortezomib and dexamethasone.

Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Velcade for: