Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 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 prior to registration
- 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 whole-body magnetic resonance imaging (MRI)
or skeletal survey should be done only if a PET/CT scan cannot be done or is
non-feasible. This must be documented in the comments section of the Onstudy form.
- 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 days prior to registration)
- 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 treatment with cardiotoxic agents,
must have a clinical risk assessment of cardiac function using the New York Heart
Association Functional Classification and must not be assessed as class 3 or 4
- 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 registration
- 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 within 28 days prior to
registration
- 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 considered secondary to the MM diagnosis,
will be allowed)
- 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 capabilities, legally
authorized representatives may sign and give informed consent on behalf of study
participants in accordance with applicable federal, local, and Central Institutional
Review Board (CIRB) regulations
Exclusion Criteria:
- 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 are permitted to be receiving
multiple anti-hypertensive medications (unless otherwise indicated in the study). All
blood pressure measurements within the 14 days prior to registration must be SBP =<
140 and DBP =< 90. A participant with a single blood pressure elevation who upon
rechecking has a normal blood pressure will remain eligible at the discretion of the
registering investigator.
- 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 efficacy assessment of the investigational regimen.
- 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 has had menses at any time in
the preceding 24 consecutive months or who has semen likely to contain sperm is
considered to be of "reproductive potential." In addition to routine contraceptive
methods, "effective contraception" also includes refraining from sexual activity that
might result in pregnancy and surgery intended to prevent pregnancy (or with a
side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy,
bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the
semen.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 7/24/23. Questions regarding updates should be directed to the study team contact.