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[M22-947] cA Dose Escalation and Expansion Study of ABBV-383 in Combination with Anti-Cancer Regimens for the Treatment of Patients with Relapsed/Refractory Multiple Myeloma

[M22-947] Relapsed or Refractory Multiple Myeloma: Dose Escalation and Expansion of ABBV-383 in Combination with Anti-Cancer Regimens

Satomi Natsuko

AbbVie G.K.

3-1-21 Shibaura, Minato-ku, Tokyo

AbbVie_JPN_info_clingov@abbvie.com

Contact for Patients and HCP

AbbVie. G.K.

3-1-21 Shibaura, Minato-ku, Tokyo

+81-120-587-874

AbbVie_JPN_info_clingov@abbvie.com

Recruiting

Oct. 18, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
- Must have confirmed diagnosis of Relapsed/Refractory (R/R) Multiple Myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) criteria.
- Must have measurable disease as outlined in the protocol.
- Must be naive to treatment with ABBV-383 and must have never received BCMA-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded.
- Has received prior MM treatment in Arms A, B, C, and D.

- Received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or an allogeneic SCT within 1 year of the first dose of study drug treatment.
- Unresolved adverse event (AE)s >= Grade 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) from prior anticancer therapy.
- Known central nervous system involvement Multiple Myeloma (MM).
- Has any of the following conditions:
-- Nonsecretory MM.
-- Active Plasma cell leukemia i.e., either 20% of peripheral white blood cells or > 2.0 x 10^9L circulating plasma cells by standard differential.
-- Waldenstrom's macroglobulinemia.
-- Light chain amyloidosis.
-- Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome.
-- Major surgery within 4 weeks prior to first dose or planned study participation.
-- Acute infections within 14 days prior to first dose of study drug requiring therapy (antibiotic, antifungal or antiviral).
-- Uncontrolled diabetes or hypertension within 14 days prior to first dose.
-- Peripheral neuropathy >= Grade 3 or >= Grade 2 with pain within 2 weeks prior to first dose.
- Known active infection of evidence of active hepatitis B, evidence of active hepatitis C, human immunodeficiency virus.

Both

Multiple Myeloma

Participants will receive intravenous (IV) ABBV-383 co-administered with oral/IV Pd, oral/IV Rd, oral/IV/subcutaneous (SC) Dd, or oral/IV Niro in 28-day cycles.

Experimental: Arm A (ABBV-383 with Pomalidomide and Dexamethasone)
Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive ABBV-383 with Pomalidomide and Dexamethasone.

Experimental: Arm B (ABBV-383 with Lenalidomide and Dexamethasone)
Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Lenalidomide and Dexamethasone.

Experimental: Arm C (ABBV-383 with Daratumumab and Dexamethasone)
Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Daratumumab and Dexamethasone.

Experimental: Arm D (ABBV-383 with Nirogacestat)
Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Nirogacestat.

Dose Limiting Toxicities (DLT)

- Overall Response Rate (ORR)
- Progression-Free Survival (PFS)
- Duration of Response (DOR)
- Time-to-Progression (TTP)
- Percentage of Participants with Minimal Residual Disease Negativity (MRD)

+81-23-628-5840

Sept. 06, 2022

No

US/Australia/Germany/Italy/Poland/Spain