A Study Designed to Evaluate the Safety and Efficacy of Venetoclax Plus Dexamethasone (VenDex) Compared With Pomalidomide Plus Dexamethasone (PomDex) in Participants With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma.

Phase 3Active Not RecruitingNCT03539744

AbbVie265 enrolled

Overview

A study designed tocompare progression-free survival (PFS) in participants with t(11;14)-positive MM treated with venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

265

Conditions

Multiple Myeloma

Interventions

PomalidomideDRUG

capsule, oral

DexamethasoneDRUG

oral, locally available form

VenetoclaxDRUG

tablet; oral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma Working Group (IMWG) criteria. * Measurable disease at screening as defined per protocol. * Has received at least 2 prior lines of therapy as described in the protocol. * Has had documented disease progression on or within 60 days after completion of the last therapy. * Has received at least 2 consecutive cycles of lenalidomide and be relapsed/refractory to lenalidomide, as defined per protocol. * Has received at least 2 consecutive cycles of a proteasome inhibitor (PI). * Has t(11;14)-positive status determined by an analytically validated fluorescent in situ hybridization (FISH) assay per centralized laboratory testing. * An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. * Laboratory values (liver, kidney and hematology laboratory values) that meet criteria as described per protocol. Exclusion Criteria: * History of treatment with venetoclax or another B-Cell Lymphoma (BCL)-2 inhibitor or pomalidomide. * History of other active malignancies, including myelodysplastic syndromes (MDS), within the past 3 years (exceptions described in the protocol). * Evidence of ongoing graft-versus-host disease (GvHD) if prior stem cell transplant (SCT). * Prior treatment with any of the following: allogeneic or syngeneic SCT within 16 weeks prior to randomization; or autologous SCT within 12 weeks prior to randomization. * Known central nervous system involvement of MM. * Concurrent conditions as listed in the protocol.

Locations (180)

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

PFS is defined as the time in days from subject randomization to the date of the first documented progressive disease (PD) or death due to any cause, whichever occurs first.

Time frame: Up to approximately 43 months from first randomization

Secondary Outcomes

Overall Response Rate (ORR)

ORR is defined as the percentage of participants with documented best response (sCR, CR, VGPR or partial response \[PR\]) prior to first documented PD.

Time frame: Up to approximately 43 months from first randomization

Very Good Partial Response or Better Response Rate (VGPR)

VGPR or better response rate is defined as the proportion of participants with documented stringent complete response (sCR), complete response (CR), or VGPR.

Time frame: Up to approximately 43 months from first randomization

Overall survival (OS)

OS is defined as the number of days from the date that the participant was randomized to the date of the participant's death.

Time frame: Up to approximately 51 months from first randomization

Minimal Residual Disease (MRD) Negativity Rate

MRD defined as the percentage of participants with MRD negativity status. MRD negativity will be defined at 10\^-5 threshold as measured by centralized testing of bone marrow aspirate samples by next generation sequencing (NGS).

Time frame: Up to approximately 43 months from first randomization

Time to Deterioration in Disease Symptoms

Time to deterioration in disease symptoms is measured by the disease symptom domain of the European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Module 20 (EORTC QLQ-MY20).

Data from ClinicalTrials.gov

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Duplicate_University of Arizona Cancer Center - North Campus /ID# 218407

Tucson, Arizona, United States

VA Central California Health Care System /ID# 200047

Fresno, California, United States

University of California, Los Angeles /ID# 171524

Los Angeles, California, United States

Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 222904

Aurora, Colorado, United States

Mayo Clinic /ID# 200075

Jacksonville, Florida, United States

Cleveland Clinic Florida /ID# 208884

Weston, Florida, United States

Duplicate_Norton Cancer Institute /ID# 200834

Louisville, Kentucky, United States

University of Maryland, Baltimore /ID# 217422

Baltimore, Maryland, United States

Boston Medical Center /ID# 223606

Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer In /ID# 201377

Detroit, Michigan, United States

...and 170 more locations

Time frame: Up to approximately 51 months from first randomization

Time to Deterioration in Physical Functioning

Time to deterioration in physical functioning is measured by the physical functioning domain of European Organization for Research and Treatment of Cancer Quality of Life Core 30 Question Questionnaire (EORTC-QLQ-C30).

Time frame: Up to approximately 51 months from first randomization

Change from Baseline in PROMIS Fatigue Score

Change from baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a score.

Time frame: Up to approximately 51 months from first randomization

Change from Baseline in BPI-SF Worst Pain Score

Change from baseline in the Brief Pain Inventory - Short Form (BPI-SF) worst pain score.

Time frame: Up to approximately 51 months from first randomization

Change from Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L)

EQ-5D-5L consists of 2 components: the EQ-5D descriptive system and the EQ visual analog scale (VAS). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the participant's self-rated health on a vertical VAS where the endpoints are labelled "The best health you can imagine" and "The worst health you can imagine."

Time frame: Up to approximately 51 months from first randomization

Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

EORTC QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).

Time frame: Up to approximately 51 months from first randomization

Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Module 20 (EORTC QLQ-MY20)

EORTC QLQ-MY20 includes scales for disease symptoms, side effects of treatment, future perspective, and body image. Values for each scale range from 0 to 100.

Time frame: Up to approximately 51 months from first randomization

Duration of response (DOR)

DOR for a participant is defined as the number of days from the date of first documented response (PR or better) to the date of first documented PD or death due to multiple myeloma, whichever occurs first.

Time frame: Up to approximately 43 months from first randomization

Time to Disease Progression (TTP)

TTP for a participant is defined as the number of days from the date of randomization to the date of first documented PD or death due to multiple myeloma, whichever occurs first.

Time frame: Up to approximately 43 months from first randomization

Time to Response (TTR)

TTR for a participant is defined as the number of days from the date of randomization to the date of first documented response (PR or better).

Time frame: Up to approximately 43 months from first randomization

Cmax of Venetoclax

Maximum plasma concentration (Cmax) of venetoclax

Time frame: Up to approximately 225 days from initial dose

Trough Concentration (Ctrough) of Venetoclax

Observed plasma concentration at trough (Ctrough) of venetoclax.

Time frame: Up to approximately 225 days from initial dose

Number of Participants With Adverse Events (AEs)

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.

Time frame: Up to approximately 51 months from first randomization