Is NCT03909412 recruiting in Hackensack, NJ?

Yes, NCT03909412 is currently recruiting participants at its Hackensack, NJ location. This multiple myeloma clinical trial is actively enrolling qualified participants.

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

To join this clinical trial in Hackensack, 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 Hackensack 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 Hackensack, NJ

About This Multiple Myeloma Study in Hackensack

This phase I study utilizes a 3+3 design with escalating cohorts of Carfilzomib at 20mg/m2, 27mg/m2, 36mg/m2, 45mg/m2, 56mg/m2, and 70mg/m2 to be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone and Granulocyte colony-stimulating factor (G-CSF)

Sponsor: Hackensack Meridian Health

Who Can Participate

Inclusion Criteria

Subject has voluntarily agreed to participate by giving written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Informed Consent must be obtained prior to mobilization.

Subject has a confirmed diagnosis of multiple myeloma as specified by the International Myeloma Working Group criteria and must have measurable disease as defined by at least one of the following criteria:

Serum monoclonal protein ≥ 0.5 g/dL

≥200 mg of monoclonal protein in the urine on 24-hour electrophoresis

Serum immunoglobulin free light chain: involved FLC ≥ 10 mg/dL (≥ 100 mg/L) AND abnormal serum immunoglobulin kappa to lambda free light chain ratio

MRD positivity in peripheral blood by flow cytometry.

Subject previously received treatment with Carfilzomib.

Subject is ≥18 years of age at the time of signing the informed consent form.

Subject has an ECOG performance status of \< 2.

Subjects must have completed any "induction therapy" and have achieved less than a CR.

Subject has a life expectancy of \>12 weeks.

Absolute neutrophil count (ANC) ≥1000 cells/mm3 (≥500 for patients with bone marrow biopsy displaying \>50% involvement by myeloma)

Platelets count ≥ 50,000/mm3 (≥ 30,000 for patients with bone marrow biopsy displaying \>50% involvement by myeloma)

Hemoglobin \> 9.0 g/dL

Serum SGOT/AST \<3.0 x upper limits of normal (ULN)

Serum SGPT/ALT \<3.0 x upper limits of normal (ULN)

Serum total bilirubin \<1.5 x ULN

Subject must have a MUGA scan or echo with LVEF ≥40% within 6 months of enrollment.

Females of childbearing potential (FCBP) must have a negative serum pregnancy test should be done within 7 days of treatment initiation and a negative urine pregnancy test within the 24 hours prior to the first study drug administration

FCBP and male subjects who are sexually active with FCBP must agree to use 2 highly effective concomitant methods of contraception including a male condom during the study and for 90 days following the last dose of study treatment

Male subjects must agree to not donate sperm while taking carfilzomib and for 90 days after the last dose of carfilzomib.

Exclusion Criteria

Subject has a history of allergic reactions to compounds containing captisol, or Carfilzomib

Subject has a NYHA Class III or IV heart disease and/or a history of active unstable angina, congestive heart disease, severe uncontrolled cardiac arrhythmia, electrocardiographic evidence of acute ischemia, active conduction system abnormalities or myocardial infarction within 6 months prior to enrollment. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.

Uncontrolled hypertension.

Pulmonary hypertension.

Known HIV infection, hepatitis C infection (subjects with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed), or hepatitis B infection (subjects with hepatitis B surface antigen or core antibody that achieve sustained virologic response with antiviral therapy are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on the study).

Subject has active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.

Subject has concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to, uncontrolled hypertension, uncontrolled diabetes, active uncontrolled infection, and/or acute chronic liver disease (i.e., hepatitis, cirrhosis).

Subject has ≥Grade 2 peripheral neuropathy.

Subject has been diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.

Subject has received radiation therapy within 3 weeks of enrollment. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy.

Subject has had prior mobilization or stem cell transplant.

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 Hackensack?

Yes, this clinical trial (NCT03909412) has an active research site in Hackensack, NJ 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 Hackensack, NJ

If you're searching for multiple myeloma treatment options in Hackensack, NJ, this clinical trial (NCT03909412) 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 Hackensack research site is actively enrolling participants for this phase 1 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 Hackensack, NJ

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