Is NCT06042725 recruiting in Rochester, MN?

Yes, NCT06042725 is currently recruiting participants at its Rochester, MN location. This multiple myeloma clinical trial is actively enrolling qualified participants.

How do I join the multiple myeloma clinical trial in Rochester?

To join this clinical trial in Rochester, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Rochester clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Multiple Myeloma Clinical Trial in Rochester, MN

About This Multiple Myeloma Study in Rochester

This phase I trial tests the safety, side effects, and best dose of venetoclax in combination with lenalidomide and dexamethasone, daratumumab and dexamethasone, or daratumumab, lenalidomide, and dexamethasone in treating patients with multiple myeloma. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Lenalidomide is a drug that is similar to thalidomide, and is used to treat multiple myeloma and certain types of anemia. Lenalidomide belongs to the family of drugs called angiogenesis inhibitors. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Adding venetoclax to the other drug combinations may allow control of the cancer than is possible with the current treatments.

Sponsor: Mayo Clinic

Who Can Participate

Inclusion Criteria

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 Criteria

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Rochester?

Yes, this clinical trial (NCT06042725) has an active research site in Rochester, MN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Multiple Myeloma Treatment Options in Rochester, MN

If you're searching for multiple myeloma treatment options in Rochester, MN, this clinical trial (NCT06042725) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Rochester research site is actively enrolling participants for this clinical trial. You'll receive care from experienced multiple myeloma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all multiple myeloma clinical trials near you to find additional studies recruiting in your area.

Multiple Myeloma Clinical Trial in Rochester, MN

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