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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06215118




Registration number
NCT06215118
Ethics application status
Date submitted
10/01/2024
Date registered
22/01/2024

Titles & IDs
Public title
A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma (MagnetisMM-30)
Scientific title
A PHASE 1B, OPEN-LABEL STUDY OF ELRANATAMAB IN COMBINATION WITH IBERDOMIDE IN PARTICIPANTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA
Secondary ID [1] 0 0
MagnetisMM-30
Secondary ID [2] 0 0
C1071030
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: Drugs - Elranatamab
Treatment: Drugs - Iberdomide

Experimental: Part 1 Dose Escalation - Non-randomized elranatamab plus iberdomide

Experimental: Part 2 Dose Randomization - Randomized elranatamab plus iberdomide


Treatment: Drugs: Elranatamab
BCMA-CD3 bispecific antibody

Treatment: Drugs: Iberdomide
cereblon-modulating agent
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Number of participants with dose limiting toxicity (DLT)
Timepoint [1] 0 0
Cycle 1, about 28 days
Primary outcome [2] 0 0
Part 2: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment
Timepoint [2] 0 0
Assessed from baseline up to 90 days after last dose of study treatment
Secondary outcome [1] 0 0
Part 1: Number of participants with Adverse Events (AE) by Seriousness and Relationship to Treatment
Timepoint [1] 0 0
Assessed from baseline up to 90 days after last dose of study treatment
Secondary outcome [2] 0 0
Part 1 and Part 2: Number of Participants with Adverse Events (AE) characterized by type, frequency, severity
Timepoint [2] 0 0
Assessed from baseline up to 90 days after last dose of study treatment
Secondary outcome [3] 0 0
Part 1 and Part 2: Number of Participants with Clinically Significant Change from Baseline in Laboratory Abnormalities
Timepoint [3] 0 0
Assessed from baseline up to 90 days after last dose of study treatment
Secondary outcome [4] 0 0
Part 1 and Part 2: Percentage of Participants with Objective Response Rate (ORR)
Timepoint [4] 0 0
Assessed for approximately 2 years
Secondary outcome [5] 0 0
Part 1 and Part 2: Percentage of Participants with Complete Response Rate (CRR)
Timepoint [5] 0 0
Assessed for approximately 2 years
Secondary outcome [6] 0 0
Part 1 and Part 2: Time to Response (TTR)
Timepoint [6] 0 0
Assessed for approximately 2 years
Secondary outcome [7] 0 0
Part 1 and Part 2: Duration of Response (DOR)
Timepoint [7] 0 0
Assessed for approximately 2 years
Secondary outcome [8] 0 0
Part 1 and Part 2: Duration of Complete Response (DOCR)
Timepoint [8] 0 0
Assessed for approximately 2 years
Secondary outcome [9] 0 0
Part 1 and Part 2: Time of Progression Free Survival (PFS)
Timepoint [9] 0 0
Assessed for approximately 2 years
Secondary outcome [10] 0 0
Part 1 and Part 2: Time of Overall Survival (OS)
Timepoint [10] 0 0
Assessed for approximately 2 years
Secondary outcome [11] 0 0
Part 1 and Part 2: Minimal Residual Disease (MRD) Negativity Rate
Timepoint [11] 0 0
Assessed for approximately 2 years
Secondary outcome [12] 0 0
Part 1 and Part 2: Concentrations of elranatamab
Timepoint [12] 0 0
Assessed for approximately 2 years
Secondary outcome [13] 0 0
Part 1 and Part 2: Concentrations of iberdomide
Timepoint [13] 0 0
Assessed for approximately 4 months
Secondary outcome [14] 0 0
Part 1 and Part 2: Percentage of participants with positive anti-drug antibodies (ADA) against elranatamab
Timepoint [14] 0 0
Assessed for approximately 2 years

Eligibility
Key inclusion criteria
* Prior diagnosis of multiple myeloma as defined by IMWG criteria
* Measurable disease based on IMWG criteria as defined by at least 1 of the following:
* Serum M-protein =0.5 g/dL by SPEP
* Urinary M-protein excretion =200 mg/24 hour by UPEP
* Serum immunoglobulin FLC =10 mg/dL (=100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FL ratio (<0.26 or >1.65)
* Part 1: Received 2-4 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
* Part 2: Received 1-3 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
* ECOG performance status 0-1
* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade =1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Plasma cell leukemia, Smoldering multiple myeloma, Waldenström's macroglobulinemia, Amyloidosis, POEMS Syndrome
* Impaired cardiovascular function or clinically significant cardiovascular diseases
* Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease
* Participants with any active, uncontrolled bacterial, fungal, or viral infection
* Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
* Previous treatment with:
* BCMA-directed or CD3 redirecting therapy
* Iberdomide (CC-220) or Mezigdomide
* Administration of strong inhibitor or inducer of CYP3A4/5 within 2 weeks prior to dosing and during the study
* Administration with an investigational product within 30 days preceding the first dose of study intervention
* Participant is unable or unwilling to undergo protocol required thromboembolism prophylaxis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/03/2028
Actual
Sample size
Target
87
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 0 0
Townsville University Hospital - Douglas
Recruitment hospital [3] 0 0
Epworth Freemasons - East Melbourne
Recruitment hospital [4] 0 0
Epworth Hospital - Richmond
Recruitment hospital [5] 0 0
Slade Pharmacy - Richmond
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
4814 - Douglas
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Nebraska
Country [6] 0 0
United States of America
State/province [6] 0 0
New Hampshire
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
Canada
State/province [10] 0 0
New Brunswick
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06215118