Venetoclax Combinations for Multiple Myeloma
This study is testing the safety and best dose of venetoclax when combined with other drugs like lenalidomide and dexamethasone, or daratumumab and dexamethasone, or all three, for people with multiple myeloma. Venetoclax works by blocking a protein called Bcl-2, which cancer cells need to survive. Lenalidomide is a drug that may stop new blood vessels from forming (angiogenesis) that help cancer grow, and dexamethasone is a steroid. You may be able to join if you have multiple myeloma with a specific genetic change called t(11;14). The main goal is to find the safest dose of venetoclax in these combinations. This study plans to enroll 100 participants.
- Study design
- This is a dose-escalation study, meaning participants will receive increasing doses of venetoclax to find the safest amount. It is an interventional study, and the phase is not specified.
- What's involved
- You would undergo procedures like blood draws, bone marrow aspirations and biopsies, and imaging tests such as chest x-rays and PET/CT scans. Treatment cycles repeat every 28 days for up to 36 cycles, or about 3 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure dose-limiting toxicity for up to 3 years after treatment begins.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06042725
MC210808 Venetoclax in Combination With Lenalidomide and Dexamethasone (Ven-Rd), Daratumumab and Dexamethasone (Ven-Dd), or Daratumumab-Lenalidomide-Dexamethasone (Ven-DRd) for the Treatment of Multiple Myeloma
Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatmentMayo ClinicInvestigator-initiated
~16 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBone Marrow AspirationBone Marrow BiopsyChest RadiographyComputed TomographyDaratumumab
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting toxicity
Measured over 28 Days (1 treatment cycle); Up to 3 years
Conditions
Where it's being run
1 sites across 1 statesMinnesota1
Study leadership
- Shaji K. Kumar, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
PRE-REGISTRATION: Diagnosis of active MM with bone marrow plasma cell fluorescence in situ hybridization (FISH) test run under an Investigational Device Exemption (IDE) demonstrating of t(11;14), either from time of diagnosis or confirmed with IDE at Mayo Clinic after time of diagnosis, during screening period for study. Note: Samples tested beyond 72 hours from the collection will not be considered adequate for trial enrollment
PRE-REGISTRATION: Group 1 - At least one prior line of therapy which did not include venetoclax
PRE-REGISTRATION: Group 2 - No more than 1 cycle of any commonly used myeloma regimen for treatment of newly diagnosed MM
PRE-REGISTRATION: Patient is not being considered for stem cell transplant (group 2, newly diagnosed only)
REGISTRATION: Age ≥ 18 years
REGISTRATION: Calculated creatinine clearance (using Cockcroft-Gault equation) ≥ 30 mL/min (obtained ≤ 14 days prior to registration)
REGISTRATION: Absolute neutrophil count (ANC) ≥ 1000/uL (without growth factor support) (obtained ≤ 14 days prior to registration)
REGISTRATION: Un-transfused Platelet count ≥ 75000/uL (≥ 50,000/uL if marrow plasma cells \[PC\]% \> 50%) (obtained ≤ 14 days prior to registration)
REGISTRATION: Hemoglobin ≥ 8.0 g/dL (transfusion permitted) (obtained ≤ 14 days prior to registration)
REGISTRATION: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (known Gilbert's syndrome are allowed provided bilirubin ≤ 2.5 mg/dL) (obtained ≤ 14 days prior to registration)
REGISTRATION: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (obtained ≤ 14 days prior to registration)
REGISTRATION: Alkaline phosphatase ≤ 750 U/L (obtained ≤ 14 days prior to registration)
REGISTRATION: Measurable disease of multiple myeloma as defined by at least ONE of the following:
Serum monoclonal protein ≥ 1.0 g/dL
≥ 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
REGISTRATION: Provide written informed consent
REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance
REGISTRATION: Negative serum pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only
REGISTRATION: Willing to follow strict birth control measures as suggested by the study
REGISTRATION: Female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
Is not a woman of childbearing potential (WOCBP) OR
Due to lenalidomide being a thalidomide analogue with risk for embryo-fetal toxicity and prescribed under a pregnancy prevention/controlled distribution program, WOCBP participants will be eligible if they commit to either:
Abstain continuously from heterosexual sexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
To use birth control as follows:
Two methods of reliable birth control (one method that is highly effective and one additional effective (barrier) method), beginning 4 weeks prior to initiating treatment with lenalidomide, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of lenalidomide treatment
REGISTRATION: Male participants are eligible to participate if they agree to the following from the time of first dose of study treatment until 28-days after the last dose of lenalidomide, to allow for clearance of any altered sperm:
Refrain from donating sperm PLUS either:
Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
Must agree to use contraception/barrier as detailed below:
Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \< 1% per year as when having sexual intercourse with a woman of childbearing potential (including pregnant females)
REGISTRATION: Life expectancy ≥ 12 weeks
REGISTRATION: Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
REGISTRATION: Willing to provide research bone marrow aspirate specimen
REGISTRATION: Willing to follow the requirements of the Revlimid (Registered Trademark) Risk Evaluation and Mitigation Strategy (REMS) program. Note: Exception for Group 2 patients enrolled on Arm A
Exclusion
PRE-REGISTRATION: History of any active malignancy within the past 2 years prior to screening, with the exception of:
Adequately treated carcinoma in situ of the uterine cervix
Adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin
Asymptomatic prostate cancer with no requirement for therapy
Previous malignancy surgically resected (or treated with other modalities) with curative intent
REGISTRATION: Other concurrent chemotherapy or any ancillary therapy considered investigational
Note: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
REGISTRATION: Major surgery ≤ 14 days prior to study registration
REGISTRATION: History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
REGISTRATION: Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
REGISTRATION: Administration of strong/moderate CYP3A inhibitors or inducers ≤ 28 days prior to registration
REGISTRATION: Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
REGISTRATION: Participation in other clinical trials, including those with other investigational agents not included in this trial, ≤ 30 days prior to registration
REGISTRATION: Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of venetoclax including difficulty swallowing REGISTRATION: Heart failure \> New York Heart Association (NYHA) class II
REGISTRATION: Presence of positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment
Note: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative hepatitis C RNA test is obtained
Note: Hepatitis RNA testing is optional and participants with negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing
What this trial measures
- Dose-limiting toxicity28 Days (1 treatment cycle); Up to 3 years
Dose-limiting toxicities (DLT) are defined according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0