Is NCT05776979 recruiting in Houston, TX?

Yes, NCT05776979 is currently recruiting participants at its Houston, TX location. This multiple myeloma clinical trial is actively enrolling qualified participants.

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

To join this clinical trial in Houston, 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 Houston 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 Houston, TX

Who Can Participate

Inclusion Criteria

Adult patients 18 to 72 years old, with newly diagnosed symptomatic (according to the revised 2014 IMWG criteria as summarized in Appendix A) myeloma. Patients must have measurable disease at diagnosis defined by any of the following:

Serum M-protein ≥1 g/dL (for IgA ≥0.5 g/dL) or urine M-protein ≥200 mg/24 hours

For oligosecretory myeloma, involved serum free light chain (FLC) level ≥10 mg/dL, provided serum FLC ratio is abnormal

For non-secretory myeloma, \> 1 focal lesions measurable by imaging

Subjects must have high-risk myeloma defined as followed:

R-ISS stage II or III patients (Appendix B)

ISS stage III (Appendix B)

≥ 3 copies +1q21 in patients with ISS Stage II/III or R-ISS Stage II/III

Presence of del(17p) cytogenetic abnormality regardless of ISS/R-ISS Stage

Presence of at least 2 high-risk genetic abnormalities \[del(17p), t(4;14), t(14;16), t(14;20), +1q21\] regardless of ISS/R-ISS stage

English and non-English speaking patients are eligible.

Karnofsky performance score of at least 70% and/or ECOG PS ≤2

Underwent ASCT using a conditioning regimen consisting of single agent Melphalan or a combination of Busulfan and Melphalan with adequate cell count recovery after transplant without the need for growth factor support or transfusions within 7 days from the lab test:

Absolute neutrophil count (ANC) ≥1000 /µL

Hemoglobin ≥8 g/dL

Platelet count ≥50,000 /µL

Patients must have achieved partial response (PR) or better prior to starting maintenance therapy.

Adequate major organ system function as demonstrated by:

Serum creatinine clearance equal or more than 30 ml/min (calculated with Cockcroft- Gault formula).

Total bilirubin equal or less than 2.0 mg/dL (equal or less than 3.0 mg/dL for patients with Gilbert's disease).

ALT or AST equal or less than 3 times the upper normal for adults.

Patient or patient's legal representative, parent(s) or guardian should provide written Internal Review Board (IRB)-approved informed consent.

Female patients included must not be pregnant or lactating. Females of childbearing potential must have (before starting treatment) a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to and again within 24 hours prior to starting Isatuximab and with each cycle of study treatment. Females of childbearing potential must refrain from becoming pregnant and commit to either apply highly effective method of birth control (two reliable methods of birth control) or continue abstinence from heterosexual intercourse during study period and for at least 5 months after last dose of Isatuximab. Patients who receive Lenalidomide should continue to follow REVLIMID REMSTM requirements.

Men of reproductive potential must agree to follow accepted birth control methods and refrain from sperm donation for the duration of the study and for at least 5 months after last dose of Isatuximab. Patients who receive Lenalidomide should continue to follow REVLIMID REMSTM requirements.

Exclusion Criteria

Progression of myeloma, as defined by the IMWG criteria (Appendix C), prior to initiation of maintenance therapy

Patients receiving any other investigational agents within 14 days or 5 half-lives of the investigational drug prior to initiation of study intervention. Exceptions can be granted after discussing with PI.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the study drugs. Hypersensitivity or history of intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study intervention that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents.

Known hypersensitivity or desquamating rash to either thalidomide or lenalidomide.

Participants must not have an active infection requiring treatment.

Participants must not have an uncontrolled intercurrent illness including, but not limited to, an uncontrolled hypertension (systolic \>170, diastolic \>100 despite antihypertensive therapy), symptomatic congestive heart failure (Class III or IV as defined by the New York Heart Association (NYHA) functional classification system), acute coronary syndrome, liver cirrhosis, and/or cognitive impairments/psychiatric illness/social situations that would limit compliance with study requirements. PI is the final arbiter of this criterion.

Major surgery within 4 weeks before initiating study treatment.

HIV-positive patients and/or active hepatitis A, B or C infections.

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 Houston?

Yes, this clinical trial (NCT05776979) has an active research site in Houston, TX 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 Houston, TX

If you're searching for multiple myeloma treatment options in Houston, TX, this clinical trial (NCT05776979) 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 Houston 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 Houston, TX

Expert Care in Houston

IRB Approved

No-Cost Care

Apply for This Houston Location

Why Participate?

Simple Process

About This Multiple Myeloma Study in Houston