Myeloma Round Table: Treating Relapsed/Refractory Disease at MD Anderson — Houston, March 26, 2022 (Part 2)
Posted: Aug 08, 2022
Although an estimated 80% of myeloma patients never have direct or indirect contact with a specialist, preferably from their initial diagnosis, is may be even more vital for patients with relapsed/refractory disease those one in their corner. Changes in diagnosis and treatment of myeloma are occurring at the fastest rate ever and only specialists have the time and expertise to keep up with it. That’s not a problem at the MD Anderson Cancer Center in Houston, TX, one of the premier myeloma research and treatment facilities in the world.
In Part 2 of this Myeloma Round Table held on March 26, 2022, Dr. Krina Patel, Dr. Hans Lee, and Nurse Practitioner Rebecca Lu explain the considerations they keep in mind when treating relapsed/refractory disease at MD Anderson. They also explain the importance of clinical trials in treatment strategies and demystify the process for patients.
Krina Patel, MD, MSc, MD Anderson Cancer Center, Houston, TX: Being Proactive about Relapsed/Refractory Myeloma
Relapsed disease means cancer has become active again
Clinical relapse must have one or more of CRAB criteria
Increase in size of existing plasmacytomas or bone lesions
Hypercalcemia >11.5 mg/dl
Decrease in hemoglobin of more than 2 g/dL
Rise in serum creatinine by 2 mg/dL or more.
Biochemical relapse - seen in tests, generally asymptomatic, shows increase of >25% from lowest responses value in any one or more of:
Serum M protein
Urine M protein
Free light chains levels
Refractory disease means cancer has stopped responding to treatment and/or progresses within 60 days of last therapy
Triple-refractory patients are resistant to all 3 classes of standard myeloma therapies
Penta-refractory means that patients are refractory to 5 classes of drugs
Goals of treating relapsed/refractory disease
Preserve your quality of life
Not every relapse requires immediate therapy
Why are clinical trials important?
Key to making progress against cancer
How do we improve our odds with myeloma?
Knowing how to choose treatments based on risk/benefit
Patient-related: age, performance status co-morbidities, social support
Antibody drug conjugate (2020): belantamab mafodotin
Antibody latches to the myeloma cell, internalizes, delivers toxins to the cell and kills it
Good possibility for elderly/frail patients
CAR T (2021): ide-cel, cilta-cel
Patient gets immune cells collected, modified to kill myeloma cells, infused back into the patient
One-time dose therapy
XPO1 inhibitor (2019)
Bispecific T cell antibody
Has 2 arms, 1 arm targets immune cells, other targets myeloma cell
Have strong efficacy and deep response rates
Myeloma is rarely treated with a single drug, combining drugs is more powerful, treatment can and must be individualized.
Factors to consider for individualized therapy:
Myeloma biology (standard vs high risk)
Type of relapse (biochemical vs clinical)
Duration of response to prior therapy
Prior drug exposures, drug-specific toxicities, standard of care vs. clinical trials
Preferences and goals, co-morbidities and age, overall health
New drugs give patients hope
Important to discuss disadvantages vs advantages with your physician to jointly decide the right treatment for you.
Become a myeloma expert, empower yourself; the future is bright
Rebecca Lu, MSN, RN, FNP-BC, MD Anderson Cancer Center, Houston, TX: Myeloma Nursing at MD Anderson
A clinical trial is a research study used to determine if a drug is safe and effective
4 clinical trial phases:
I: establishes dose and safety profile of drug
II: establishes efficacy and further assess the safety
III: compare treatment with standard of care
IV: extend safety and activity in the post-marketing scenario to assess long-term use
Members of clinical trials teams:
Principal investigator: responsible for the conduct of the study
Study coordinator: implements the study
Sponsor: a pharmaceutical company that provides funding and protocol
Institutional review board
Patient is identified or self-identified
Research team reviews patient’s chart to determine eligibility
Physician identifies study and discusses with patient
Research team reaches out to patient to give overview and request permission for financial clearance
Obtain financial clearance, consent, then screen and enroll
Standard of care costs: things that are usually done, routine care: diagnostic testing, treatment are billed to insurance or patient
Research costs: extra things used in the study, for example extra bone marrow biopsies, can be covered by insurance
Consent - a document providing details of the study and signed by the patient
Keep team informed
Reimbursements: keep receipts
Treatment windows give patients flexibility
Keep a pill diary and return empty pill bottles
May have more frequent testing (bone marrow biopsies) and more frequent follow-up visits
Results may take some time
Median overall survival is better in patients enrolled in frontline studies!
Discuss this with your medical team, stay informed: www.clinicaltrials.gov
Questions & Answers
0:20 - Can antibody drug conjugates can be used as a bridging therapy for CAR T? Are some bridging therapies the help or harm one’s immune system?
6:10 - Are there any new trials or treatments targeting 17p deletion?
8:20 - Can venetoclax, daratumumab, and dexamethasone be used in combination?
12:00 - What is the experience with the GPRC5D targeted immunotherapies?
14:54 - Does a non-secretory patient have any hope In getting into a clinical trial?
15:35 - What should you do about a patient that is hesitant about not staying on maintenance therapy?
18:00 - What is the role of ixazomib as a maintenance therapy?
19:34 - Can you comment on a free light chain ratio reading 100 as an indication of progression to active myeloma from smoldering? Is this a controversial marker?
22:25 - Could you discuss a stem cell boost to decrease cytopenias so that a patient can become eligible for CAR T procedure?
24:54 - Could you discuss patient-reported outcomes and what that means? How does it help research?
28:24 - What is diversity equity inclusion and how does it relate to clinical trials?
32:30 - A person newly diagnosed with myeloma has indicators of high-risk disease, back fractures, normal kidneys, is 77 years old, and very active. Is he a candidate for stem cell transplant or is he too old?
35:54 - Real-world evidence is a big issue for researchers in the future of cancer. Can you explain what it is and can it be used to accelerate research and answer questions regarding sequencing subpopulations and value assessment?
39:10 - When you have newly diagnosed patients, how would you present all this information for them? How do you communicate long-term and short-term goals?
45:08 - Can you explain the significance of t(11;14)? (Includes discussion of importance of genetic information.)
47:00 - For patients concerned about quality of life issues and in long-term maintenance: Are there any breakthroughs or major studies for for quality of life issues like neuropathy, chemobrain, etc?
50:55 - How do you balance long-term maintenance in patients who have long-term MRD negativity (MRD-)?
55:16 - How often do you see patients that have genetic differences depending on maybe different cells from different locations in the body and how do you approach treatment in a situation like that?
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about the author Andrea Robles
Andrea Robles is an International Medical Graduate, part of Healthtree’s patient navigator staff. She is committed to patient’s global wellness and finding a cure through research. She’s also a wife and mom of 3.