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
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Dose Escalation: Lemzoparlimab Participants will receive lemzoparlimab in 28 day cycles. |
Biological: Lemzoparlimab
Intravenous (IV) infusion
Other Names:
|
Experimental: Dose Escalation: Lemzoparlimab + Pomalidomide + Dexamethasone Participants will receive lemzoparlimab + pomalidomide + dexamethasone in 28 day cycles. |
Biological: Lemzoparlimab
Intravenous (IV) infusion
Other Names:
Drug: Dexamethasone
Oral tablet or IV infusion/injection
Drug: Pomalidomide
Oral capsule
|
Experimental: Dose Escalation: Lemzoparlimab + Carfilzomib + Dexamethasone Participants will receive lemzoparlimab + carfilzomib + dexamethasone in 28 day cycles. |
Biological: Lemzoparlimab
Intravenous (IV) infusion
Other Names:
Drug: Dexamethasone
Oral tablet or IV infusion/injection
Drug: Carfilzomib
IV infusion
|
Experimental: Dose Escalation: Lemzoparlimab + Daratumumab + Dexamethasone Participants will receive lemzoparlimab + daratumumab + dexamethasone in 28 day cycles. |
Biological: Lemzoparlimab
Intravenous (IV) infusion
Other Names:
Drug: Dexamethasone
Oral tablet or IV infusion/injection
Biological: Daratumumab
Subcutaneous (SC) injection
|
Experimental: Dose Expansion: Lemzoparlimab Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion in 28 day cycles. |
Biological: Lemzoparlimab
Intravenous (IV) infusion
Other Names:
|
Experimental: Dose Expansion: Lemzoparlimab + Dexamethasone Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + dexamethasone in 28 day cycles. |
Biological: Lemzoparlimab
Intravenous (IV) infusion
Other Names:
Drug: Dexamethasone
Oral tablet or IV infusion/injection
|
Experimental: Dose Expansion: Lemzoparlimab + Pomalidomide + Dexamethasone Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + pomalidomide + dexamethasone in 28 day cycles. |
Biological: Lemzoparlimab
Intravenous (IV) infusion
Other Names:
Drug: Dexamethasone
Oral tablet or IV infusion/injection
Drug: Pomalidomide
Oral capsule
|
Experimental: Dose Expansion: Lemzoparlimab + Carfilzomib + Dexamethasone Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + carfilzomib + dexamethasone in 28 day cycles. |
Biological: Lemzoparlimab
Intravenous (IV) infusion
Other Names:
Drug: Dexamethasone
Oral tablet or IV infusion/injection
Drug: Carfilzomib
IV infusion
|
Experimental: Dose Expansion: Lemzoparlimab + Daratamumab + Dexamethasone Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + daratamumab + dexamethasone in 28 day cycles. |
Biological: Lemzoparlimab
Intravenous (IV) infusion
Other Names:
Drug: Dexamethasone
Oral tablet or IV infusion/injection
Biological: Daratumumab
Subcutaneous (SC) injection
|
Outcome Measures
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) [Up to 28 days after study drug administration]
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 [Up to approximately 2 years]
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) [Up to approximately 2 years]
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) [Up to approximately 2 years]
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) [Up to approximately 2 years]
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.
Eligibility Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Arizona Cancer Center - Tucson /ID# 229696 | Tucson | Arizona | United States | 85724 |
2 | Yale University /ID# 230438 | New Haven | Connecticut | United States | 06510 |
3 | Sylvester Comprehensive Cancer Center /ID# 228817 | Miami | Florida | United States | 33136-1002 |
4 | Moffitt Cancer Center /ID# 229939 | Tampa | Florida | United States | 33612-9416 |
5 | University of Kentucky Markey Cancer Center /ID# 229506 | Lexington | Kentucky | United States | 40536-7001 |
6 | Norton Cancer Institute - St Matthews /ID# 229319 | Louisville | Kentucky | United States | 40207 |
7 | Tulane Cancer Center Clinic /ID# 229832 | New Orleans | Louisiana | United States | 70112 |
8 | University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 229309 | Ann Arbor | Michigan | United States | 48109 |
9 | Henry Ford Health System /ID# 230341 | Detroit | Michigan | United States | 48202 |
10 | Rutgers Cancer Institute of New Jersey /ID# 230174 | New Brunswick | New Jersey | United States | 08901 |
11 | Columbia University Medical Center /ID# 229971 | New York | New York | United States | 10032-3729 |
12 | Duke University Hospital /ID# 229564 | Durham | North Carolina | United States | 27710 |
13 | Wake Forest Baptist Health /ID# 229996 | Winston-Salem | North Carolina | United States | 27157-0001 |
14 | Perelman Center for Advanced Medicine - /ID# 228693 | Philadelphia | Pennsylvania | United States | 19104-5127 |
15 | Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 229473 | Dallas | Texas | United States | 75246-2003 |
16 | University of Texas Southwestern Medical Center /ID# 228830 | Dallas | Texas | United States | 75390-7208 |
17 | University of Virginia /ID# 229396 | Charlottesville | Virginia | United States | 22908 |
18 | Concord Hospital /ID# 229351 | Concord | New South Wales | Australia | 2139 |
19 | Princess Alexandra Hospital /ID# 229343 | Woolloongabba | Queensland | Australia | 4102 |
20 | The Queen Elizabeth Hospital /ID# 229345 | Woodville South | South Australia | Australia | 5011 |
21 | Royal Hobart Hospital /ID# 229348 | Hobart | Tasmania | Australia | 7000 |
22 | Box Hill Hospital /ID# 240762 | Box Hill | Victoria | Australia | 3128 |
23 | St Vincent's Hospital Melbourne /ID# 229349 | Fitzroy Melbourne | Victoria | Australia | 3065 |
24 | Austin Health /ID# 229352 | Heidelberg | Victoria | Australia | 3084 |
25 | Alfred Health /ID# 229347 | Melbourne | Victoria | Australia | 3004 |
26 | HCL - Hôpital Lyon Sud /ID# 229834 | Pierre Benite CEDEX | Auvergne-Rhone-Alpes | France | 69495 |
27 | CHU de Nantes, Hotel Dieu -HME /ID# 228559 | Nantes | Pays-de-la-Loire | France | 44000 |
28 | CHU Poitiers - La milétrie /ID# 229833 | Poitiers | Poitou-Charentes | France | 86000 |
29 | Hopital Henri Mondor /ID# 228562 | Creteil | France | 94000 | |
30 | Universitaetsklinik Heidelberg /ID# 229145 | Heidelberg | Baden-Wuerttemberg | Germany | 69120 |
31 | Robert-Bosch-Krankenhaus /ID# 230290 | Stuttgart | Baden-Wuerttemberg | Germany | 70736 |
32 | Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 230291 | Berlin | Germany | 12203 | |
33 | Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 229141 | Hamburg | Germany | 20246 | |
34 | Asklepios Klinik Altona /ID# 229143 | Hamburg | Germany | 22763 | |
35 | Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 230007 | Munich | Germany | 81675 | |
36 | The Chaim Sheba Medical Center /ID# 229483 | Ramat Gan | Tel-Aviv | Israel | 5265601 |
37 | Tel Aviv Sourasky Medical Center /ID# 229478 | Tel Aviv-Yafo | Tel-Aviv | Israel | 6423906 |
38 | Rambam Health Care Campus /ID# 229485 | Haifa | Israel | 3109601 | |
39 | Hadassah Medical Center-Hebrew University /ID# 229477 | Jerusalem | Israel | 91120 | |
40 | Meir Medical Center /ID# 229480 | Kfar Saba | Israel | 4428164 | |
41 | Rabin Medical Center /ID# 229488 | Petakh Tikva | Israel | 4941492 | |
42 | Nagoya City University Hospital /ID# 241835 | Nagoya shi | Aichi | Japan | 467-8602 |
43 | National Cancer Center Hospital East /ID# 241834 | Kashiwa-shi | Chiba | Japan | 277-8577 |
44 | Kyushu University Hospital /ID# 241911 | Fukuoka-shi | Fukuoka | Japan | 812-8582 |
45 | Gunma University Hospital /ID# 241837 | Maebashi-shi | Gunma | Japan | 371-8511 |
46 | National Hospital Organization Mito Medical Center /ID# 244043 | Higashi Ibaraki-gun | Ibaraki | Japan | 311-3193 |
47 | University Hospital Kyoto Prefectural University of Medicine /ID# 241833 | Kyoto-shi | Kyoto | Japan | 602-8566 |
48 | Japanese Red Cross Medical Center /ID# 241836 | Shibuya-ku | Tokyo | Japan | 150-8935 |
49 | Hospital Clínico Universitario de Santiago-CHUS /ID# 229356 | Santiago de Compostela | A Coruna | Spain | 15706 |
50 | Hospital Unversitario Marques de Valdecilla /ID# 229354 | Santander | Cantabria | Spain | 39008 |
51 | Hospital Parc de Salut del Mar /ID# 229371 | Barcelona | Spain | 08003 | |
52 | Hospital Santa Creu i Sant Pau /ID# 229369 | Barcelona | Spain | 08041 | |
53 | Hospital Universitario Reina Sofia /ID# 229388 | Cordoba | Spain | 14004 | |
54 | Hospital Universitario 12 de Octubre /ID# 229355 | Madrid | Spain | 28041 | |
55 | University Hospital Southampton NHS Foundation Trust /ID# 228332 | Southampton | Hampshire | United Kingdom | SO16 6YD |
56 | Guy's and St Thomas' NHS Foundation Trust /ID# 228323 | London | London, City Of | United Kingdom | SE1 9RT |
57 | Oxford University Hospitals NHS Foundation Trust /ID# 228328 | Oxford | Oxfordshire | United Kingdom | OX3 9DU |
58 | Leeds Teaching Hospitals NHS Trust /ID# 228333 | Leeds | United Kingdom | LS9 7TF | |
59 | The Christie Hospital /ID# 228330 | Manchester | United Kingdom | M20 4BX |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: ABBVIE INC., AbbVie
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M20-917
- 2021-001067-24