Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Lemzoparlimab With or Without Oral/IV Dexamethasone and in Combination With Oral/IV/Subcutaneous Anti-Myeloma Regimens in Adult Participants With Multiple Myeloma

Part of paid clinical trials in Miami, Florida.

Sponsor
AbbVie
Study ID
NCT04895410
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lemzoparlimab — BIOLOGICAL
    Intravenous (IV) infusion
  • Dexamethasone — DRUG
    Oral tablet or IV infusion/injection
  • Carfilzomib — DRUG
    IV infusion
  • Pomalidomide — DRUG
    Oral capsule
  • Daratumumab — BIOLOGICAL
    Subcutaneous (SC) injection

Study Details

Multiple myeloma (MM) accounts for more than 10% of all blood cancers and 1% of all cancers. The purpose of this study is to assess how safe lemzoparlimab is and how lemzoparlimab moves through the body of adult participants with MM when given with or without dexamethasone, and in combination with other anti-myeloma regimens. Adverse events and change in disease activity will be assessed. Lemzoparlimab is an investigational drug being developed for the treatment of relapsed/refractory (R/R) MM. Study doctors put the participants in groups called treatment arms. Two different dose levels of lemzoparlimab will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of lemzoparlimab, followed by a dose expansion phase to confirm the dose. Approximately 163 adult participants with R/R MM will be enrolled in the study in approximately 60 sites worldwide. In the Dose Escalation arms, participants will receive intravenous (IV) lemzoparlimab with or without dexamethasone (oral/IV) in combination with pomalidomide (oral) or carfilzomib (IV) or subcutaneous (SC) daratumumab in 28-day cycles. In the Dose Expansion arms, participants will receive lemzoparlimab (IV) alone or with dexamethasone (oral/IV) in combination with pomalidomide (oral) or carfilzomib (IV) or daratumumab (SC) in 28-day cycles. 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests and side effects.

Key Dates

Start date
Jan 17, 2022
Status verified
Aug 2022
Primary completion
Jun 24, 2022
Completion
Jun 24, 2022

Study Design

Enrollment
8 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation: Lemzoparlimab
    Participants will receive lemzoparlimab in 28 day cycles.
  • Experimental: Dose Escalation: Lemzoparlimab + Pomalidomide + Dexamethasone
    Participants will receive lemzoparlimab + pomalidomide + dexamethasone in 28 day cycles.
  • Experimental: Dose Escalation: Lemzoparlimab + Carfilzomib + Dexamethasone
    Participants will receive lemzoparlimab + carfilzomib + dexamethasone in 28 day cycles.
  • Experimental: Dose Escalation: Lemzoparlimab + Daratumumab + Dexamethasone
    Participants will receive lemzoparlimab + daratumumab + dexamethasone in 28 day cycles.
  • Experimental: Dose Expansion: Lemzoparlimab
    Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion in 28 day cycles.
  • Experimental: Dose Expansion: Lemzoparlimab + Dexamethasone
    Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + dexamethasone in 28 day cycles.
  • Experimental: Dose Expansion: Lemzoparlimab + Pomalidomide + Dexamethasone
    Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + pomalidomide + dexamethasone in 28 day cycles.
  • Experimental: Dose Expansion: Lemzoparlimab + Carfilzomib + Dexamethasone
    Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + carfilzomib + dexamethasone in 28 day cycles.
  • Experimental: Dose Expansion: Lemzoparlimab + Daratamumab + Dexamethasone
    Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + daratamumab + dexamethasone in 28 day cycles.

Primary Outcome Measure

Dose Limiting Toxicities (DLTs) of Lemzoparlimab With or Without Dexamethasone and in Combination With Anti-myeloma Regimens in Participants With Relapsed/Refractory (R/R) Multiple Myeloma (MM) [ Time Frame: Up to 28 days after study drug administration ]

Locations (12)

FacilityCityStateZIPSite coordinators
Sylvester Comprehensive Cancer Center /ID# 228817MiamiFlorida33136-1002-
Moffitt Cancer Center /ID# 229939TampaFlorida33612-9416-
Norton Cancer Institute - St Matthews /ID# 229319LouisvilleKentucky40207-
Tulane Cancer Center Clinic /ID# 229832New OrleansLouisiana70112-
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 229309Ann ArborMichigan48109-
Henry Ford Health System /ID# 230341DetroitMichigan48202-
Rutgers Cancer Institute of New Jersey /ID# 230174New BrunswickNew Jersey08901-
Columbia University Medical Center /ID# 229971New YorkNew York10032-3729-
Duke University Hospital /ID# 229564DurhamNorth Carolina27710-
Wake Forest Baptist Health /ID# 229996Winston-SalemNorth Carolina27157-0001-
Perelman Center for Advanced Medicine - /ID# 228693PhiladelphiaPennsylvania19104-5127-
University of Virginia /ID# 229396CharlottesvilleVirginia22908-

Find similar trials in Miami, FL

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Sylvester Comprehensive Cancer Center· Miami, FLMoffitt Cancer Center· Tampa, FLNorton Cancer Institute - St Matthews· Louisville, KYTulane Cancer Center Clinic· New Orleans, LAUniversity of Michigan Comprehensive Cancer Center Michigan Medicine· Ann Arbor, MIHenry Ford Health System· Detroit, MI

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