Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04895410




Registration number
NCT04895410
Ethics application status
Date submitted
19/05/2021
Date registered
20/05/2021
Date last updated
6/03/2023

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
2021-001067-24
Secondary ID [2] 0 0
M20-917
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Lemzoparlimab
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Carfilzomib
Treatment: Drugs - Pomalidomide
Treatment: Other - Daratumumab

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.


Treatment: Other: Lemzoparlimab
Intravenous (IV) infusion

Treatment: Drugs: Dexamethasone
Oral tablet or IV infusion/injection

Treatment: Drugs: Carfilzomib
IV infusion

Treatment: Drugs: Pomalidomide
Oral capsule

Treatment: Other: Daratumumab
Subcutaneous (SC) injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Up to 28 days after study drug administration
Secondary outcome [1] 0 0
Percentage of Participants Achieving Best Overall Response of Documented Partial Response (PR) or Better
Timepoint [1] 0 0
Up to approximately 2 years
Secondary outcome [2] 0 0
Progression Free Survival (PFS)
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
Up to approximately 2 years
Secondary outcome [4] 0 0
Time to Progression (TTP)
Timepoint [4] 0 0
Up to approximately 2 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/06/2022
Sample size
Target
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital /ID# 229345 - Woodville South
Recruitment hospital [2] 0 0
Alfred Health /ID# 229347 - Melbourne
Recruitment postcode(s) [1] 0 0
5011 - Woodville South
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
France
State/province [10] 0 0
Auvergne-Rhone-Alpes
Country [11] 0 0
France
State/province [11] 0 0
Pays-de-la-Loire
Country [12] 0 0
France
State/province [12] 0 0
Poitou-Charentes
Country [13] 0 0
France
State/province [13] 0 0
Creteil
Country [14] 0 0
Germany
State/province [14] 0 0
Hamburg
Country [15] 0 0
Israel
State/province [15] 0 0
Tel-Aviv
Country [16] 0 0
Israel
State/province [16] 0 0
Haifa
Country [17] 0 0
Israel
State/province [17] 0 0
Jerusalem
Country [18] 0 0
Israel
State/province [18] 0 0
Kfar Saba
Country [19] 0 0
Israel
State/province [19] 0 0
Petakh Tikva
Country [20] 0 0
Japan
State/province [20] 0 0
Kyoto
Country [21] 0 0
Spain
State/province [21] 0 0
A Coruna
Country [22] 0 0
Spain
State/province [22] 0 0
Cantabria
Country [23] 0 0
Spain
State/province [23] 0 0
Barcelona
Country [24] 0 0
Spain
State/province [24] 0 0
Cordoba
Country [25] 0 0
Spain
State/province [25] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04895410
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04895410