Phase 1Recruiting

Comparing Daratumumab with Sonrotoclax for relapsed/refractory multiple myeloma

Official title: A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

A Phase 1b/2 Dose-Escalation and Cohort-Expansion Study to Determine the Safety and Efficacy of BGB-11417as Monotherapy, in Combination With Dexamethasone, Dexamethasone/Carfilzomib, Dexamethasone/Daratumumab, and Dexamethasone/Pomalidomide in Patients With Relapsed/Refractory Multiple Myeloma and t(11;14)

Condition: Relapsed/Refractory Multiple MyelomaSponsor: BeOne MedicinesTarget enrollment: 246

Phase 1
2 groups
Sites in Edmonton, Vancouver and 1 more city
Recruiting

Interventions (5)

Medication
Sonrotoclax
Administered orally daily
Medication
Dexamethasone
Once weekly either orally or intravenously
Medication
Carfilzomib
Administered intravenously weekly
Medication
Daratumumab
Administered subcutaneously weekly
Medication
Pomalidomide
Administered orally daily

Canadian Sites (3)

3 of 3 recruiting

Cross Cancer Institute
Edmonton, Alberta
Recruiting
British Columbia Cancer Agency the Vancouver Centre
Vancouver, British Columbia
Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario
Recruiting

See who this study is looking for39 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

+Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
+Participants in Part 2 Cohorts 6 and 7 should have relapsed or progressive disease and have had 1 to 3 prior lines of therapy and previously treated with a proteasome inhibitor and an IMiD
+A confirmed diagnosis of multiple myeloma (must have an M-component in serum and/or urine)
+Measurable disease defined as:
+i. M-spike ≥ 500mg/dL, or ii. Urine protein M-spike of ≥ 200 mg/day, or iii. Serum free light chains ≥ 10 mg/dL, and an abnormal κ:λ ratio
+Participant has documented relapsed or progressive MM on or after any regimen or who are refractory to the most recent line of therapy.
+i. Relapsed MM is defined as previously treated MM that progresses and requires initiation of salvage therapy but does not meet the criteria for refractory MM.
+ii. Refractory MM is 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.
+In Part 1 and Part 2 Cohorts 1 and 2 participants should have relapsed or progressive disease and have had ≥ 3 prior lines of therapy including a proteasome inhibitor, an IMiD, and an anti-CD38 monoclonal antibody, and no more available approved therapies.
+Participants in Part 2 Cohorts 3, 4, and 5 should have relapsed or progressive disease and have had ≥ 1 prior line of therapy. Prior treatment with carfilzomib is allowed but the patient must not be considered carfilzomib refractory by the investigator.
+Positivity for t(11;14) translocation must be confirmed by validated fluorescence in situ hybridization (FISH) testing assay in a pre-defined laboratory
+a. fresh bone marrow aspirate sample must be collected at screening and sent to central laboratory for t(11;14) FISH testing.
+Adequate organ function defined as:
+Hemoglobin ≥ 8.0 g/dL within 7 days before first dose of study treatment, (transfusions, in accordance with institutional guidelines, are permitted)
+Platelet count ≥ 75,000/μL, within 7 days before first dose of study treatment, independent of growth factor support and transfusions
+Absolute neutrophil count (ANC) ≥ 1000/mm\^3 within 7 days before first dose of study treatment
+Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN) and total bilirubin ≤ 2.0 x ULN N (total bilirubin must be \< 3 x ULN for patients with Gilbert's syndrome)

Exclusion

−Known infection with human immunodeficiency virus (HIV)
−Serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows:
−Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Participants with presence of HBcAb, but absence of HBsAg, are eligible if HBV DNA is undetectable (limitation of sensitivity \< 20 IU/mL) ,), and if they are willing to undergo monthly monitoring for HBV reactivation.
−Presence of HCV antibody. Participants with presence of HCV antibody are eligible if HCV RNA is undetectable (limitation of sensitivity \< 15 IU/mL).
−Participant has any of the following conditions:
−Non secretory MM (Serum free light chains \< 10 mg/dL)
−Solitary plasmacytoma
−Active plasma cell leukemia (ie, either 20% of peripheral white blood cells or \> 2.0 x 109/L circulating plasma cells by standard differential)
−Waldenström macroglobulinemia (WM)
−Amyloidosis.
−Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome
−Chronic respiratory disease that requires continuous oxygen
−Significant cardiovascular disease, including but not limited to:
−Myocardial infarction ≤ 6 months before screening
−Ejection fraction ≤ 50%
−Unstable angina≤ 3 months before screening
−New York Heart Association Class III or IV congestive heart failure
−History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
−Heart rate-corrected QT interval \> 480 milliseconds based on Fridericia's formula
−History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place
−Uncontrolled hypertension at screening, defined as systolic blood pressure \> 170 mmHg and diastolic blood pressure \> 105 mmHg by ≥ 2 consecutive measurements. Prior therapy with sonrotoclax or other agents inhibiting BCL2 activity (eg, venetoclax)
−Note: Other protocol defined Inclusion/Exclusion criteria may apply.

5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning

What this study is

This study is testing a treatment for a condition.

Phase 1/2 — a combined study that starts with early safety and continues into what the treatment does.

From the trial registry

Built from these fields:

designModule.designInfo.primaryPurpose
designModule.phases

Who receives what

There are 2 groups in this study.

Group A receives one or more of: Sonrotoclax, Dexamethasone, Carfilzomib, Daratumumab and Pomalidomide.

Registry label: A: Part 1 Dose Escalation

Group B receives one or more of: Sonrotoclax, Dexamethasone and Carfilzomib.

Registry label: B: Part 2 Cohort Expansion

From the trial registry

Built from these fields:

armsInterventionsModule.armGroups[].label
armsInterventionsModule.armGroups[].type
armsInterventionsModule.armGroups[].interventionNames

How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-label: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

designModule.designInfo.allocation
designModule.designInfo.maskingInfo.masking

Is there a placebo?

This study does not list a placebo group.

From the trial registry

Built from these fields:

armsInterventionsModule.armGroups[].type
armsInterventionsModule.armGroups[].interventionNames

Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteers.

These are the criteria the study lists. Only the trial site can decide whether someone can take part.

From the trial registry

Built from these fields:

eligibilityModule.minimumAge
eligibilityModule.sex
eligibilityModule.healthyVolunteers

How big and how long

The study aims to enrol about 246 people.

The study is currently expected to finish around November 2026.

The main measurement is taken over: Up to 28 days.

From the trial registry

Built from these fields:

designModule.enrollmentInfo.count
statusModule.completionDateStruct.date
outcomesModule.primaryOutcomes[].timeFrame

What the study measures

Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs) — measured over Up to 28 days.

Part 1 And 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events Leading to Discontinuation and Adverse Events of Special Interest (AESIs) — measured over Up to 30 days after last dose of study drug.

Part 2: Overall response rate (ORR) as Assessed by Investigator — measured over Approximately 4 years.

Part 2: Very Good Partial Response (VGPR) or Better Response Rate as Assessed by Investigator — measured over Upon study termination (Baseline up to first documentation of disease progression [PD] or death from any cause [approximately 4 years].

The study lists 1 further main measurements.

From the trial registry

Built from these fields:

outcomesModule.primaryOutcomes[].measure
outcomesModule.primaryOutcomes[].timeFrame

Source: NCT04973605 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?