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A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma

Primary Purpose

Relapsed/Refractory Multiple Myeloma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ABBV-383
Dexamethasone
Lenalidomide
Pomalidomide
Nirogacestat
Daratumumab
Sponsored by
TeneoOne Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed/Refractory Multiple Myeloma focused on measuring Relapsed/Refractory Multiple Myeloma, Pomalidomide, Dexamethasone, Lenalidomide, Daratumumab, Nirogacestat, ABBV-383, Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 naïve 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.

Exclusion Criteria:

  • 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 × 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.

Sites / Locations

  • University of Arkansas for Medical Sciences /ID# 243096Recruiting
  • Sylvester Comprehensive Cancer Center /ID# 243673Recruiting
  • Moffitt Cancer Center /ID# 243437Recruiting
  • University of Massachusetts - Worcester /ID# 243977Recruiting
  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438Recruiting
  • The Valley Hospital /ID# 243829Recruiting
  • Rutenberg Cancer Center /ID# 244647Recruiting
  • Memorial Sloan Kettering Cancer Center /ID# 244656Recruiting
  • Levine Cancer Institute, Atrium Health /ID# 242851Recruiting
  • University of Texas Southwestern Medical Center /ID# 243273Recruiting
  • Huntsman Cancer Institute /ID# 242872Recruiting
  • University of Washington /ID# 243172Recruiting
  • Froedtert Memorial Lutheran Hospital /ID# 242654Recruiting
  • St George Hospital /ID# 243740Recruiting
  • Calvary Mater Newcastle /ID# 243730Recruiting
  • Monash Medical Centre /ID# 244403Recruiting
  • Epworth Healthcare /ID# 243734Recruiting
  • Fiona Stanley Hospital /ID# 244753Recruiting
  • Universitaetsklinikum Tuebingen /ID# 242815Recruiting
  • Universitaetsklinikum Essen /ID# 242819Recruiting
  • Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 243141Recruiting
  • Universitaetsklinikum Regensburg /ID# 242837Recruiting
  • Universitaetsklinikum Wuerzburg /ID# 242826Recruiting
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 242582Recruiting
  • Ospedale San Raffaele IRCCS /ID# 242583Recruiting
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 242581Recruiting
  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 242584Recruiting
  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 244057Recruiting
  • Nagoya City University Hospital /ID# 249094Recruiting
  • National Cancer Center Hospital East /ID# 245889Recruiting
  • Hokkaido University Hospital /ID# 245966Recruiting
  • Kanazawa University Hospital /ID# 246812Recruiting
  • Okayama Medical Center /ID# 245882Recruiting
  • Yamagata University Hospital /ID# 245888Recruiting
  • Szpital Wojewodzki w Opolu sp. z o.o. /ID# 243954Recruiting
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 243246Recruiting
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 243500Recruiting
  • Uniwersyteckie Centrum Kliniczne /ID# 243249Recruiting
  • Hospital Duran i Reynals /ID# 242979Recruiting
  • CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 242977Recruiting
  • Hospital Universitario Vall d'Hebron /ID# 242976Recruiting
  • Hospital Clinic de Barcelona /ID# 242978Recruiting
  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 244145Recruiting
  • Hospital Universitario 12 de Octubre /ID# 242975Recruiting
  • Hospital Universitario Virgen del Rocio /ID# 242974Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm A (ABBV-383 with Pomalidomide and Dexamethasone)

Arm B (ABBV-383 with Lenalidomide and Dexamethasone)

Arm C (ABBV-383 with Daratumumab and Dexamethasone)

Arm D (ABBV-383 with Nirogacestat)

Arm Description

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.

Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Lenalidomide and Dexamethasone.

Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Daratumumab and Dexamethasone.

Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Nirogacestat.

Outcomes

Primary Outcome Measures

Number of Participants with Dose Limiting Toxicities (DLT) of ABBV-383
DLT events as described in the protocol will be assessed.
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

Secondary Outcome Measures

Overall Response Rate (ORR)
ORR is defined as partial response(PR) + very good partial response (VGPR) + complete remission (CR) + stringent complete response (sCR); proportion of participants who achieved a PR or better.
Progression-Free Survival (PFS)
PFS is defined as the number of days from the date of first dose to the date of earliest disease progression or death.
Duration of Response (DOR)
DOR will be defined as the number of days from the date of first response (sCR, CR, VGPR, or PR) to the earliest recurrence, progressive disease, or death, whatever occurs first.
Time-to-Progression (TTP)
TTP is defined as the number of days from the date of first dose to the date of earliest disease progression.
Percentage of Participants with Minimal Residual Disease Negativity (MRD)
MRD is defined as the percentage of participants with assessment of the minimal residual disease.

Full Information

First Posted
February 18, 2022
Last Updated
October 19, 2023
Sponsor
TeneoOne Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05259839
Brief Title
A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma
Official Title
A Dose Escalation and Expansion Study of ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2022 (Actual)
Primary Completion Date
November 29, 2028 (Anticipated)
Study Completion Date
November 29, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TeneoOne Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and toxicity of ABBV-383 when co-administered with pomalidomide-dexamethasone (Pd), lenalidomide-dexamethasone (Rd), daratumumab-dexamethasone (Dd), or nirogacestat (Niro) in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease activity will be assessed. ABBV-383 is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. ABBV-383 co-administered with Pd, Rd, Dd, or Niro 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 ABBV-383, followed by a dose expansion phase to confirm the dose. Approximately 270 adult participants with R/R MM will be enrolled in the study in approximately 45 sites worldwide. 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. 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, questionnaires and side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Multiple Myeloma
Keywords
Relapsed/Refractory Multiple Myeloma, Pomalidomide, Dexamethasone, Lenalidomide, Daratumumab, Nirogacestat, ABBV-383, Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A (ABBV-383 with Pomalidomide and Dexamethasone)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B (ABBV-383 with Lenalidomide and Dexamethasone)
Arm Type
Experimental
Arm Description
Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Lenalidomide and Dexamethasone.
Arm Title
Arm C (ABBV-383 with Daratumumab and Dexamethasone)
Arm Type
Experimental
Arm Description
Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Daratumumab and Dexamethasone.
Arm Title
Arm D (ABBV-383 with Nirogacestat)
Arm Type
Experimental
Arm Description
Participants with R/R MM who meet the criteria outline in the protocol will receive ABBV-383 with Nirogacestat.
Intervention Type
Drug
Intervention Name(s)
ABBV-383
Intervention Description
Intravenous (IV) Infusion
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Oral; Tablet or IV Infusion
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Oral; Capsule
Intervention Type
Drug
Intervention Name(s)
Pomalidomide
Intervention Description
Oral; Capsule
Intervention Type
Drug
Intervention Name(s)
Nirogacestat
Intervention Description
Oral; Tablet
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Intervention Description
Subcutaneous Injection (SC)
Primary Outcome Measure Information:
Title
Number of Participants with Dose Limiting Toxicities (DLT) of ABBV-383
Description
DLT events as described in the protocol will be assessed.
Time Frame
Up to approximately 28 Days
Title
Number of Participants with Adverse Events (AEs)
Description
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Time Frame
Up to Approximately 3 Years
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR is defined as partial response(PR) + very good partial response (VGPR) + complete remission (CR) + stringent complete response (sCR); proportion of participants who achieved a PR or better.
Time Frame
Up to Approximately 3 Years
Title
Progression-Free Survival (PFS)
Description
PFS is defined as the number of days from the date of first dose to the date of earliest disease progression or death.
Time Frame
Up to Approximately 3 Years
Title
Duration of Response (DOR)
Description
DOR will be defined as the number of days from the date of first response (sCR, CR, VGPR, or PR) to the earliest recurrence, progressive disease, or death, whatever occurs first.
Time Frame
Up to Approximately 3 Years
Title
Time-to-Progression (TTP)
Description
TTP is defined as the number of days from the date of first dose to the date of earliest disease progression.
Time Frame
Up to Approximately 3 Years
Title
Percentage of Participants with Minimal Residual Disease Negativity (MRD)
Description
MRD is defined as the percentage of participants with assessment of the minimal residual disease.
Time Frame
Up to Approximately 3 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 naïve 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. Exclusion Criteria: 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 × 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TeneoOne Inc
Organizational Affiliation
TeneoOne Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Arkansas for Medical Sciences /ID# 243096
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Name
Sylvester Comprehensive Cancer Center /ID# 243673
City
Miami
State/Province
Florida
ZIP/Postal Code
33136-1002
Country
United States
Individual Site Status
Recruiting
Facility Name
Moffitt Cancer Center /ID# 243437
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9416
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Massachusetts - Worcester /ID# 243977
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
The Valley Hospital /ID# 243829
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Individual Site Status
Recruiting
Facility Name
Rutenberg Cancer Center /ID# 244647
City
New York
State/Province
New York
ZIP/Postal Code
10029-6030
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center /ID# 244656
City
New York
State/Province
New York
ZIP/Postal Code
10065-6007
Country
United States
Individual Site Status
Recruiting
Facility Name
Levine Cancer Institute, Atrium Health /ID# 242851
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204-2812
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas Southwestern Medical Center /ID# 243273
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-7208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
214-648-3111
Facility Name
Huntsman Cancer Institute /ID# 242872
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5500
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Washington /ID# 243172
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Name
Froedtert Memorial Lutheran Hospital /ID# 242654
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3522
Country
United States
Individual Site Status
Recruiting
Facility Name
St George Hospital /ID# 243740
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Recruiting
Facility Name
Calvary Mater Newcastle /ID# 243730
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Individual Site Status
Recruiting
Facility Name
Monash Medical Centre /ID# 244403
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Name
Epworth Healthcare /ID# 243734
City
Richmond
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Individual Site Status
Recruiting
Facility Name
Fiona Stanley Hospital /ID# 244753
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Tuebingen /ID# 242815
City
Tubingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Essen /ID# 242819
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 243141
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Regensburg /ID# 242837
City
Regensburg
ZIP/Postal Code
93042
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Wuerzburg /ID# 242826
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 242582
City
Rome
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Raffaele IRCCS /ID# 242583
City
Milan
State/Province
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 242581
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 242584
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 244057
City
Milan
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Nagoya City University Hospital /ID# 249094
City
Nagoya shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital East /ID# 245889
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hokkaido University Hospital /ID# 245966
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanazawa University Hospital /ID# 246812
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Individual Site Status
Recruiting
Facility Name
Okayama Medical Center /ID# 245882
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yamagata University Hospital /ID# 245888
City
Yamagata-shi
State/Province
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Individual Site Status
Recruiting
Facility Name
Szpital Wojewodzki w Opolu sp. z o.o. /ID# 243954
City
Opole
State/Province
Dolnoslaskie
ZIP/Postal Code
45-372
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 243246
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-556
Country
Poland
Individual Site Status
Recruiting
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 243500
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-081
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne /ID# 243249
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital Duran i Reynals /ID# 242979
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 242977
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall d'Hebron /ID# 242976
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic de Barcelona /ID# 242978
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 244145
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre /ID# 242975
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocio /ID# 242974
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma

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