BridgeMD
Compares treatment options for Plasma Cell Myeloma
Official title Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment
ClinicalTrials.gov ID: NCT05561387
What this study is testing
What is Bortezomib?
Bortezomib is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for plasma cell myeloma.
Also referred to as [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, LDP 341.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase III trial compares three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, and functional status. Treatment for multiple myeloma includes initial treatment (induction) which is the first treatment a patient receives for cancer followed by ongoing treatment (maintenance) which is given after initial treatment to help keep the cancer from coming back.
- Phase 3: a large, late-stage study
- Time commitment: about 10 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Participants must have documented multiple myeloma satisfying standard International Myeloma Working Group (IMWG) diagnostic criteria within 28 days...
- Participants must have measurable disease within 28 days prior to registration as defined by any of the following:
- Immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein [M-protein] level \>= 0.5 gram/deciliter [g/dL] or urine M-protein level \>= 200...
- IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level \>= 0.2 g/dL or urine M-protein level \>= 200 mg/24 hrs); OR
- Light chain multiple myeloma (serum immunoglobulin free light chain \>= 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain...
You likely can't join if
- Participants must not have received any prior systemic therapy for multiple myeloma with the exception of any one or more of the following:
- An emergency use of a short course of corticosteroids (equivalent of dexamethasone 160 mg) any time before registration, or
- Up to one complete cycle of a non-daratumumab and hyaluronidase-fihj containing anti-myeloma regimen (1 cycle = 21 or 28 days depending on the...
- Localized palliative radiation therapy for multiple myeloma, as long as the radiation therapy is completed at least 3 days prior to starting the...
- Participants must not have evidence of grade 4 peripheral neuropathy prior to study registration
- Participants must not have uncontrolled blood pressure within 14 days prior to registration. Uncontrolled blood pressure: systolic blood pressure...
See the full eligibility criteria
Who can join
- Participants must have documented multiple myeloma satisfying standard International Myeloma Working Group (IMWG) diagnostic criteria within 28 days prior to registration
- Participants must have measurable disease within 28 days prior to registration as defined by any of the following:
- Immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein [M-protein] level \>= 0.5 gram/deciliter [g/dL] or urine M-protein level \>= 200 milligram[mg]/24 hours[hrs]); OR
- IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level \>= 0.2 g/dL or urine M-protein level \>= 200 mg/24 hrs); OR
- Light chain multiple myeloma (serum immunoglobulin free light chain \>= 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio)
- All disease must be assessed and documented on the baseline/pre-registration tumor assessment form
- Participants must have a calculated myeloma frailty index (Myeloma Frailty Score Calculator; http://www.myelomafrailtyscorecalculator.net/) categorized as frail or intermediate fit (regardless of age) within 28 days...
- For Participants Meeting "Frail" Status:
- Participants with any degree of kidney dysfunction are allowed; however, participants on dialysis are not eligible
- For Participants Meeting "Frail" Status:
- Hemoglobin \>= 7 g/dL (must be performed within 28 days prior to registration)
- Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM)
- For Participants Meeting "Frail" Status:
- Platelets \>= 50 x 10\^9/L (must be performed within 28 days prior to registration)
- Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM)
- For Participants Meeting "Frail" Status:
- Absolute neutrophil count (ANC) \>= 0.75 x10\^9/L (must be performed within 28 days prior to registration)
- Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM)
- For Participants Meeting "Intermediate Fit" Status, one or more of the following criteria must be present:
- Kidney dysfunction showing calculated creatinine clearance (CrCl) \<30 ml/min.
- Actual lab serum creatinine value with a minimum of 0.7 mg/dL.
- Participants must have bone marrow function assessed and meet the below criteria ranges:
- Hemoglobin between 7-8 g/dL, OR
- Platelets between 50-75 x10\^9/L, OR
- ANC between 0.75-1 x10\^9/L
- Note: growth factor and transfusion utilization are allowed as long as cytopenias are considered secondary to bone marrow involvement from MM)
- Revised International Staging System (R-ISS) stage III disease
- Note: All labs must be performed within 28 days prior to registration
- Participants must have a complete medical history and physical exam within 28 days prior to registration
- Participants must have whole body imaging within 60 days prior to registration. The recommended method of imaging is a positron emission tomography/computed tomography (PET/CT); a low-dose whole body CT scan or...
- Total bilirubin =\< 2 times institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional ULN (within 28...
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 × institutional ULN (within 28 days prior to registration)
- Participants must have adequate cardiac function, as assessed by the treating physician within 14 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of...
- Participants with known diabetes must show evidence of controlled disease within 14 days prior to registration. Uncontrolled diabetes is defined as: A glycosylated hemoglobin (Hg)A1C \> 7
- Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test on the most recent test result obtained, within 6 months prior to...
- All participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, participant must have an undetectable HCV viral load...
- Participants must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status score of 0-2 (Note: Participants with ECOG/Zubrod performance score [PS] 3, especially where the deterioration of PS is...
- Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) specimen tracking system
- Participants who are able to complete the patient-reported outcomes measures in English or Spanish must agree to participate in the PRO portion of the study
- Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making...
What rules you out
- Participants must not have received any prior systemic therapy for multiple myeloma with the exception of any one or more of the following:
- An emergency use of a short course of corticosteroids (equivalent of dexamethasone 160 mg) any time before registration, or
- Up to one complete cycle of a non-daratumumab and hyaluronidase-fihj containing anti-myeloma regimen (1 cycle = 21 or 28 days depending on the regimen being used), or
- Localized palliative radiation therapy for multiple myeloma, as long as the radiation therapy is completed at least 3 days prior to starting the systemic treatment as per the study protocol.
- Participants must not have evidence of grade 4 peripheral neuropathy prior to study registration
- Participants must not have uncontrolled blood pressure within 14 days prior to registration. Uncontrolled blood pressure: systolic blood pressure (SBP) \> 140 mmHg or diastolic blood pressure (DBP) \> 90 mmHg...
- Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or how well it works assessment of...
- Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who...
The study team makes the final eligibility decision.
Where it's taking place
- Anchorage, Alaska, United States
- Phoenix, Arizona, United States
- Fort Smith, Arkansas, United States
- Little Rock, Arkansas, United States
- Arroyo Grande, California, United States
- Burbank, California, United States
- Cameron Park, California, United States
- Carmichael, California, United States
- Elk Grove, California, United States
- Marysville, California, United States
- Merced, California, United States
- Napa, California, United States
- Rocklin, California, United States
- Sacramento, California, United States
- San Luis Obispo, California, United States
- Santa Maria, California, United States
- Santa Rosa, California, United States
- Truckee, California, United States
- Woodland, California, United States
- Aurora, Colorado, United States
+ 270 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anchorage, Alaska, United States; Phoenix, Arizona, United States; Fort Smith, Arkansas, United States; Little Rock, Arkansas, United States; Arroyo Grande, California, United States; Burbank, California, United States and 284 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.