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Immunotherapy

Venetoclax Combinations for Multiple Myeloma

Phase 1

Recruiting

Led By Shaji K. Kumar, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No prior treatment for multiple myeloma (group 2) and at least one prior line of therapy which did not include venetoclax (group 1)

No more than 1 cycle of any commonly used myeloma regimen for treatment of newly diagnosed MM

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial tests if adding venetoclax to existing treatments can help treat multiple myeloma.

Who is the study for?

Adults with multiple myeloma, specifically those who have a certain genetic marker (t(11;14)) detected by a special test. Participants must be willing to follow strict birth control measures due to risks associated with lenalidomide. They should not have had more than one prior treatment cycle for newly diagnosed patients or any previous venetoclax treatments for others. Key organ functions must meet specific criteria and they cannot be planning stem cell transplants.Check my eligibility

What is being tested?

The trial is testing the safety and optimal dosing of venetoclax combined with other drugs: lenalidomide and dexamethasone, daratumumab and dexamethasone, or all three together in treating multiple myeloma. These combinations are being studied to see if they can better control cancer compared to current treatments.See study design

What are the potential side effects?

Potential side effects include risk of infection, blood clots, nerve damage, low blood counts leading to fatigue or bleeding problems, diarrhea or constipation, muscle cramps or aches, rash or itching skin. There may also be an increased risk of developing new cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You have not received treatment for multiple myeloma (group 2), or you have received at least one treatment that did not include venetoclax (group 1).

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I have had only one treatment cycle for my newly diagnosed multiple myeloma.

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I abstain from heterosexual sex as a long-term choice.

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I choose not to have heterosexual intercourse and will continue this choice.

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I am not being considered for a stem cell transplant.

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose-limiting toxicity

Secondary outcome measures

Best response while on treatment

Frequency and severity of treatment-emergent adverse events

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm C (Ven-DRd)Experimental Treatment14 Interventions

Patients receive venetoclax PO QD on days 1-28 of each cycle, daratumumab SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7+, lenalidomide PO QD on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, and 22 of cycles 1-12. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo chest x-ray and optional collection of blood samples during screening. In addition, patients undergo x-rays, WBLDCT, PET/CT or MRI scans during screening and on study, and bone marrow aspiration and biopsy during screening, on study, and during follow-up.

Group II: Arm B (Ven-Rd)Experimental Treatment13 Interventions

Patients receive venetoclax PO QD on days 1-28 of each cycle, lenalidomide PO QD on days 1-21 of each cycle, and dexamethasone PO on days 1, 8, 15, 22 of cycles 1-12. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo chest x-ray and optional collection of blood samples during screening. In addition, patients undergo x-rays, WBLDCT, PET/CT or MRI scans during screening and on study, and bone marrow aspiration and biopsy during screening, and during follow-up.

Group III: Arm A (Ven-Dd)Experimental Treatment13 Interventions

Patients receive venetoclax PO QD on days 1-28 of each cycle, daratumumab SC on days 1, 8, 15, and 22 of cycles 1-2, days 1 and 15 of cycles 3-6, and day 1 of cycles 7+, and dexamethasone PO on days 1, 8, 15, 22 of cycles 1-12. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo chest x-ray and optional collection of blood samples during screening. In addition, patients undergo x-rays, WBLDCT, PET/CT or MRI scans during screening and on study, and bone marrow aspiration and biopsy during screening, and during follow-up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~1990

Lenalidomide

2005

Completed Phase 3

~1480

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Low Dose Computed Tomography of the Whole Body

2021

Completed Phase 2

~10

Biospecimen Collection

2004

Completed Phase 2

~1700

Bone Marrow Biopsy

2021

Completed Phase 2

~10

Chest Radiography

2018

N/A

~560

Positron Emission Tomography

2008

Completed Phase 2

~2240

Daratumumab

2014

Completed Phase 3

~1990

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Dexamethasone

2007

Completed Phase 4

~2590

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,216 Previous Clinical Trials

3,767,388 Total Patients Enrolled

76 Trials studying Multiple Myeloma

9,611 Patients Enrolled for Multiple Myeloma

Shaji K. Kumar, M.D.Principal InvestigatorMayo Clinic in Rochester

8 Previous Clinical Trials

2,679 Total Patients Enrolled

8 Trials studying Multiple Myeloma

2,679 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the drug Ven-Dd attained regulatory authorization from the Food and Drug Administration?

"Based on our evaluation, the safety of Arm A (Ven-Dd) is scored at 1 due to this being a Phase 1 trial and limited clinical evidence backing its efficacy and security."

Answered by AI

Is enrollment in this trial currently available for participants?

"According to the data hosted on clinicaltrials.gov, this research endeavour is no longer actively enrolling patients, having been last updated on September 15th 2023 after first being posted 28 days prior. However, 812 other studies are presently looking for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06042725.