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Multiple Myeloma- Do Oncologists Pressure Clinical Trial Entry?

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There is no person more vulnerable than a newly-diagnosed multiple myeloma (MM) patient. If you’ve enrolled in a clinical trial, you’ve got to wonder if you were pressured by your oncologist in any way.

I can’t speak to the issue of race in the treatment of multiple myeloma MM patients. But I can speak to the issue of clinical trial enrollment. I believe that I was “enrolled” in a clinical trial falsely and I’ve worked with many newly diagnosed MM patients who also felt pressured by their oncologist to participate in a clinical trial when they didn’t want to participate.

I didn’t know that I participated in the Granisetron trial described below when I went through active therapy for my multiple myeloma from my diagnosis in 2/94 through my diagnosis of end-stage MM in 9/97. Yet my medical file that I obtained in mid-’18 notes that I participated in this trial when I went through high-dose cytoxan therapy in 9/95.

I have a clear memory of being asked to participate in a different clinical trial, and agreeing, but no memory of agreeing to participate in the Granisetron trial.

My point in writing this post is simply to warn newly diagnosed MM patients about the potential for pressure to participate in a clinical trial from their oncologist.

Whether a patient participates or not is completely up to them. But it should be the patient’s choice, not the oncologist’s choice.

Have you been diagnosed with multiple myeloma? Have you been pressured to participate in a clinical trial? Scroll down the page, post a question or comment and I will reply to you ASAP.

Hang in there,

David Emerson

  • MM Survivor
  • MM Cancer Coach
  • Director PeopleBeatingCancer

Recommended Reading:

Seeking Trial Enrollment, Oncologist Alienates Patient

“An oncologist’s ambition to enroll her patient into a clinical trial generated distrust and touched on a historical hurt involving informed consent, according to the patient’s daughter, who is also a medical student.

Shakkaura Kemet, MPH, who is studying medicine at the University of California, San Francisco (UCSF), accompanied her mom to the physician visit. She writes her account of the doctor–patient interaction in an essay published online today in The New England Journal of Medicine.

“Early on in that initial oncology appointment, the doctor asked my mother to enroll in a clinical trial of an [experimental] combination of chemotherapy drugs. Each drug worked well individually, she told us, and her team wanted to see whether they would work even better together,” writes Kemet.

“She emphasized that the drugs were safe,” Kemet continued.

“The silence that ensued while the doctor glossed over countless pages of side effects was terrifying and painful.”

“Unbeknownst to her, the doctor had already lost our trust,” Kemet writes.

The doctor, a woman, never explained the mother’s diagnosis or prognosis during the visit — as was promised by the oncologist when Kemet and her mother made the appointment.

“Nothing had been done to address my mother’s fears about her disease, its treatment, or her own mortality,” adds Kemet.

“My mother had only one question: ‘So, I do have cancer, then?’ ”

“Oh, yes,” said the doctor.

Kemet asked the rest of the questions on behalf of her mom. Were there any nonexperimental treatments? Could they have time to think about the options? Yes, the doctor answered, and yes.

In the end, the mother decided to be treated with established, standard care for her early-stage cancer.

When the pair returned for the mother’s first chemotherapy treatment, a nurse informed them that she had been assigned to another physician. The mother “never saw the first doctor again — a fact that only confirmed our suspicions,” writes Kemet.

The suspicion: the mother was fodder for the oncologist’s research cannon.

Kemet articulates it this way: “…it seemed that the oncologist saw her as a body whose value resided in the contribution it could make to future scientific discovery, not a patient in need of care.”

More to the Story

If that was the end of the story, the essay may not have made the pages of the influential NEJM.

Soon after that patient visit with her mom, Kemet — who was an undergraduate at Harvard at the time of her mother’s cancer diagnosis — was assigned to read The Immortal Life of Henrietta Lacks for a medical anthropology class. The book describes how a black woman’s cancer cells, when cultivated in cell lines, were used to profit the big business of science for decades — without her informed consent.

Kemet and her mother are both black women. And the experience with the oncologist — and what they perceived as her slippery attempt to get their consent — revives some unpleasant memories, both personal and historical, about the institution of American medicine.

Kemet rattles off a few of the personal ones: The multiple times doctors have confused the mother’s medical charts with those of other black female patients. Or the time a doctor dismissed her medication side effects as stress related. Or the time a physician empathetically asked about the mother’s hypertension and diabetes — a nice gesture, except that she didn’t have either disease

Three years after her mom’s initial oncology appointment, Kemet graduated from Harvard and moved onto medical school at UCSF. There, she was the copresident of the Student National Medical Association and invited the family of Henrietta Lacks to speak at her school.

Kemet worries the Lacks story might be dated and irrelevant to informed young people. Research helps her dismiss the worry.

“…black American patients still express greater concern than their white counterparts do about the likelihood of experiencing harm from participating in clinical trials,” she writes.

And they should be concerned, she says, citing a study published last year in Health Affairs.

“A recent systematic review of studies that do not require informed consent found that black patients accounted for 29% of enrollees in such clinical trials even though they account for only 13% of the U.S. population,” Kemet points out.

Finally, the UCSF medical student explains that what happened to her mom could happen to others — and not just other black women. Nevertheless, she and her mother saw the experience “through the lens of our history and personal experiences.”

And that history includes Henrietta Lacks, who is still relevant, 60 years later: “Henrietta Lacks became a part of clinical research without giving her consent because her doctors failed to see her as fully human. More than half a century later, my mother chose not to participate in a clinical trial because she felt that her doctor failed her in the same way.”

N Engl J Med. Published online August 29, 2019. Full text”

A dose-finding study of granisetron, a novel antiemetic, in patients receiving high-dose cisplatin

“In this double-blind study, the efficacy and safety of a single intravenous dose of a novel antiemetic, granisetron, was assessed at two dose levels (40 μg/kg and 160 μg/kg). A group of 355 patients were given prophylactic granisetron prior to receiving highdose cisplatin chemotherapy. In the first 24 h, 57% and 59% of patients, respectively, experienced no vomiting and no more than mild nausea.

Two further doses of granisetron (40 μg/kg) were permitted in the first 24 h to treat any emergent symptoms of nausea and vomiting; 66 patients (39%) in the 40-μg/kg treatment group and 56 patients (34%) in the 160-μg/kg group received at least one additional dose.

Additional treatment with granisetron resulted in resolution or improvement of symptoms in at least 73% of these patients. Over the 7-day study period, 52% of patients in the lower-dose group and 48% in the higher required no further conventional antiemetic therapy. The two different dose levels were equal both in terms in efficacy and safety. Granisetron was well tolerated throughout the dose range of the study [40–240 μg kg-1 (24 h)-1].

The commonest adverse event was headache, seen in 14%–16% of patients. In all but one case this resolved spontaneously or responded to simple treatment.”


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