Back to resultsStudy 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
Primary Purpose
Multiple Myeloma
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Lemzoparlimab
Dexamethasone
Carfilzomib
Pomalidomide
Daratumumab
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Lemzoparlimab, ABBV-IMAB-TJC4, Relapsed or refractory multiple myeloma (R/R MM), Cancer, TJ011133, Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
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.
- Relapsed defined as previously treated myeloma that progresses and requires initiation of salvage therapy, but does not meet criteria for refractory myeloma.
- Refractory defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease) while on primary or salvage therapy, or progresses within 60 days of last therapy.
- Measurable disease per the protocol within 28 days prior to enrollment.
Arm A - Lemzoparlimab with or without Dexamethasone
- For Both Escalation and Expansion Phase, participant must have refractory to 3 prior lines of treatment of anti-myeloma treatments, as outlined in the protocol.
Arm B - Lemzoparlimab + Pomalidomide-Dexamethasone
- For Escalation Phase - Participant must have received at least 3 prior lines of therapy, as outlined in the protocol.
- For Expansion Phase- Participant must have received at least 2 prior line of therapy, as outlined in the protocol.
Arm C - Lemzoparlimab + Carfilzomib-Dexamethasone
- For Escalation Phase- Participant must have received at least 3 prior lines of therapy as outlined in the protocol.
- For Expansion Phase- Participant must have received at least 1 prior line of therapy.
- Arm D - Lemzoparlimab + Daratumumab-Dexamethasone -- For Both Escalation and Expansion Phase - Participant must: --- Have received at least 3 prior lines of therapy, as outlined in the protocol.
Exclusion Criteria:
Arm B - Lemzoparlimab + Pomalidomide-Dexamethasone
- For Both Escalation and Expansion Phase participant must have had no prior treatment with pomalidomide.
Arm C - Lemzoparlimab + Carfilzomib-Dexamethasone
- For Both Escalation and Expansion Phase - prior treatment with carfilzomib.
Arm D - Lemzoparlimab + Daratumumab-Dexamethasone
- For Both Escalation and Expansion Phase - prior treatment with daratumumab or other anti-CD38 therapy.
Sites / Locations
- Sylvester Comprehensive Cancer Center /ID# 228817
- Moffitt Cancer Center /ID# 229939
- Norton Cancer Institute - St Matthews /ID# 229319
- Tulane Cancer Center Clinic /ID# 229832
- University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 229309
- Henry Ford Health System /ID# 230341
- Rutgers Cancer Institute of New Jersey /ID# 230174
- Columbia University Medical Center /ID# 229971
- Duke University Hospital /ID# 229564
- Wake Forest Baptist Health /ID# 229996
- Perelman Center for Advanced Medicine - /ID# 228693
- University of Virginia /ID# 229396
- The Queen Elizabeth Hospital /ID# 229345
- Alfred Health /ID# 229347
- HCL - Hôpital Lyon Sud /ID# 229834
- CHU de Nantes, Hotel Dieu -HME /ID# 228559
- CHU Poitiers - La milétrie /ID# 229833
- Hopital Henri Mondor /ID# 228562
- Asklepios Klinik Altona /ID# 229143
- The Chaim Sheba Medical Center /ID# 229483
- Tel Aviv Sourasky Medical Center /ID# 229478
- Rambam Health Care Campus /ID# 229485
- Hadassah Medical Center-Hebrew University /ID# 229477
- Meir Medical Center /ID# 229480
- Rabin Medical Center /ID# 229488
- University Hospital Kyoto Prefectural University of Medicine /ID# 241833
- Hospital Clínico Universitario de Santiago-CHUS /ID# 229356
- Hospital Unversitario Marques de Valdecilla /ID# 229354
- Hospital Parc de Salut del Mar /ID# 229371
- Hospital Santa Creu i Sant Pau /ID# 229369
- Hospital Universitario Reina Sofia /ID# 229388
- Hospital Universitario 12 de Octubre /ID# 229355
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Dose Escalation: Lemzoparlimab
Dose Escalation: Lemzoparlimab + Pomalidomide + Dexamethasone
Dose Escalation: Lemzoparlimab + Carfilzomib + Dexamethasone
Dose Escalation: Lemzoparlimab + Daratumumab + Dexamethasone
Dose Expansion: Lemzoparlimab
Dose Expansion: Lemzoparlimab + Dexamethasone
Dose Expansion: Lemzoparlimab + Pomalidomide + Dexamethasone
Dose Expansion: Lemzoparlimab + Carfilzomib + Dexamethasone
Dose Expansion: Lemzoparlimab + Daratamumab + Dexamethasone
Arm Description
Participants will receive lemzoparlimab in 28 day cycles.
Participants will receive lemzoparlimab + pomalidomide + dexamethasone in 28 day cycles.
Participants will receive lemzoparlimab + carfilzomib + dexamethasone in 28 day cycles.
Participants will receive lemzoparlimab + daratumumab + dexamethasone in 28 day cycles.
Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion in 28 day cycles.
Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + dexamethasone in 28 day cycles.
Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + pomalidomide + dexamethasone in 28 day cycles.
Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + carfilzomib + dexamethasone in 28 day cycles.
Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + daratamumab + dexamethasone in 28 day cycles.
Outcomes
Primary Outcome Measures
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)
DLT events as described in the protocol will be assessed.
Secondary Outcome Measures
Percentage of Participants Achieving Best Overall Response of Documented Partial Response (PR) or Better
Best overall response is defined as achieving documented PR or better at two consecutive disease assessments during the study, according to International Myeloma Working Group (IMWG) 2016 criteria.
Progression Free Survival (PFS)
PFS is defined as the time from the first dose of study drug to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
Duration of Response (DOR)
DOR is defined as the time from first documented response (PR or better) to the first documented PD or death due to MM, whichever occurs first.
Time to Progression (TTP)
TTP is defined as the time from the first dose of study drug to the first documented PD or death due to MM, whichever occurs first.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04895410
Brief Title
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
Official Title
A Phase 1b, Dose Escalation and Expansion Study of Lemzoparlimab With or Without Dexamethasone and in Combination With Anti-Myeloma Regimens for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Strategic considerations
Study Start Date
January 17, 2022 (Actual)
Primary Completion Date
June 24, 2022 (Actual)
Study Completion Date
June 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
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) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Lemzoparlimab, ABBV-IMAB-TJC4, Relapsed or refractory multiple myeloma (R/R MM), Cancer, TJ011133, Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose Escalation: Lemzoparlimab
Arm Type
Experimental
Arm Description
Participants will receive lemzoparlimab in 28 day cycles.
Arm Title
Dose Escalation: Lemzoparlimab + Pomalidomide + Dexamethasone
Arm Type
Experimental
Arm Description
Participants will receive lemzoparlimab + pomalidomide + dexamethasone in 28 day cycles.
Arm Title
Dose Escalation: Lemzoparlimab + Carfilzomib + Dexamethasone
Arm Type
Experimental
Arm Description
Participants will receive lemzoparlimab + carfilzomib + dexamethasone in 28 day cycles.
Arm Title
Dose Escalation: Lemzoparlimab + Daratumumab + Dexamethasone
Arm Type
Experimental
Arm Description
Participants will receive lemzoparlimab + daratumumab + dexamethasone in 28 day cycles.
Arm Title
Dose Expansion: Lemzoparlimab
Arm Type
Experimental
Arm Description
Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion in 28 day cycles.
Arm Title
Dose Expansion: Lemzoparlimab + Dexamethasone
Arm Type
Experimental
Arm Description
Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + dexamethasone in 28 day cycles.
Arm Title
Dose Expansion: Lemzoparlimab + Pomalidomide + Dexamethasone
Arm Type
Experimental
Arm Description
Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + pomalidomide + dexamethasone in 28 day cycles.
Arm Title
Dose Expansion: Lemzoparlimab + Carfilzomib + Dexamethasone
Arm Type
Experimental
Arm Description
Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + carfilzomib + dexamethasone in 28 day cycles.
Arm Title
Dose Expansion: Lemzoparlimab + Daratamumab + Dexamethasone
Arm Type
Experimental
Arm Description
Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + daratamumab + dexamethasone in 28 day cycles.
Intervention Type
Biological
Intervention Name(s)
Lemzoparlimab
Other Intervention Name(s)
TJ011133
Intervention Description
Intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Oral tablet or IV infusion/injection
Intervention Type
Drug
Intervention Name(s)
Carfilzomib
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Pomalidomide
Intervention Description
Oral capsule
Intervention Type
Biological
Intervention Name(s)
Daratumumab
Intervention Description
Subcutaneous (SC) injection
Primary Outcome Measure Information:
Title
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)
Description
DLT events as described in the protocol will be assessed.
Time Frame
Up to 28 days after study drug administration
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Best Overall Response of Documented Partial Response (PR) or Better
Description
Best overall response is defined as achieving documented PR or better at two consecutive disease assessments during the study, according to International Myeloma Working Group (IMWG) 2016 criteria.
Time Frame
Up to approximately 2 years
Title
Progression Free Survival (PFS)
Description
PFS is defined as the time from the first dose of study drug to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
Time Frame
Up to approximately 2 years
Title
Duration of Response (DOR)
Description
DOR is defined as the time from first documented response (PR or better) to the first documented PD or death due to MM, whichever occurs first.
Time Frame
Up to approximately 2 years
Title
Time to Progression (TTP)
Description
TTP is defined as the time from the first dose of study drug to the first documented PD or death due to MM, whichever occurs first.
Time Frame
Up to approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Relapsed defined as previously treated myeloma that progresses and requires initiation of salvage therapy, but does not meet criteria for refractory myeloma.
Refractory defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease) while on primary or salvage therapy, or progresses within 60 days of last therapy.
Measurable disease per the protocol within 28 days prior to enrollment.
Arm A - Lemzoparlimab with or without Dexamethasone
For Both Escalation and Expansion Phase, participant must have refractory to 3 prior lines of treatment of anti-myeloma treatments, as outlined in the protocol.
Arm B - Lemzoparlimab + Pomalidomide-Dexamethasone
For Escalation Phase - Participant must have received at least 3 prior lines of therapy, as outlined in the protocol.
For Expansion Phase- Participant must have received at least 2 prior line of therapy, as outlined in the protocol.
Arm C - Lemzoparlimab + Carfilzomib-Dexamethasone
For Escalation Phase- Participant must have received at least 3 prior lines of therapy as outlined in the protocol.
For Expansion Phase- Participant must have received at least 1 prior line of therapy.
Arm D - Lemzoparlimab + Daratumumab-Dexamethasone -- For Both Escalation and Expansion Phase - Participant must: --- Have received at least 3 prior lines of therapy, as outlined in the protocol.
Exclusion Criteria:
Arm B - Lemzoparlimab + Pomalidomide-Dexamethasone
For Both Escalation and Expansion Phase participant must have had no prior treatment with pomalidomide.
Arm C - Lemzoparlimab + Carfilzomib-Dexamethasone
For Both Escalation and Expansion Phase - prior treatment with carfilzomib.
Arm D - Lemzoparlimab + Daratumumab-Dexamethasone
For Both Escalation and Expansion Phase - prior treatment with daratumumab or other anti-CD38 therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Sylvester Comprehensive Cancer Center /ID# 228817
City
Miami
State/Province
Florida
ZIP/Postal Code
33136-1002
Country
United States
Facility Name
Moffitt Cancer Center /ID# 229939
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9416
Country
United States
Facility Name
Norton Cancer Institute - St Matthews /ID# 229319
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Tulane Cancer Center Clinic /ID# 229832
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 229309
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Health System /ID# 230341
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey /ID# 230174
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Columbia University Medical Center /ID# 229971
City
New York
State/Province
New York
ZIP/Postal Code
10032-3729
Country
United States
Facility Name
Duke University Hospital /ID# 229564
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest Baptist Health /ID# 229996
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-0001
Country
United States
Facility Name
Perelman Center for Advanced Medicine - /ID# 228693
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-5127
Country
United States
Facility Name
University of Virginia /ID# 229396
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
The Queen Elizabeth Hospital /ID# 229345
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Alfred Health /ID# 229347
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
HCL - Hôpital Lyon Sud /ID# 229834
City
Pierre Benite CEDEX
State/Province
Auvergne-Rhone-Alpes
ZIP/Postal Code
69495
Country
France
Facility Name
CHU de Nantes, Hotel Dieu -HME /ID# 228559
City
Nantes
State/Province
Pays-de-la-Loire
ZIP/Postal Code
44000
Country
France
Facility Name
CHU Poitiers - La milétrie /ID# 229833
City
Poitiers
State/Province
Poitou-Charentes
ZIP/Postal Code
86000
Country
France
Facility Name
Hopital Henri Mondor /ID# 228562
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Asklepios Klinik Altona /ID# 229143
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
The Chaim Sheba Medical Center /ID# 229483
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center /ID# 229478
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Rambam Health Care Campus /ID# 229485
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah Medical Center-Hebrew University /ID# 229477
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Meir Medical Center /ID# 229480
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin Medical Center /ID# 229488
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
University Hospital Kyoto Prefectural University of Medicine /ID# 241833
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Hospital Clínico Universitario de Santiago-CHUS /ID# 229356
City
Santiago de Compostela
State/Province
A Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Unversitario Marques de Valdecilla /ID# 229354
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Parc de Salut del Mar /ID# 229371
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau /ID# 229369
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario Reina Sofia /ID# 229388
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre /ID# 229355
City
Madrid
ZIP/Postal Code
28041
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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