Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Belantamab Mafodotin - blmf (BLENREP) given for the treatment of relapsed and/or refractory multiple myeloma.

Blenrep

Thomas W LeBlanc, MD

The purpose of this study is to describe the real-world use of Belantamab Mafodotin - blmf (BLENREP) and associated patterns of care, including dosing and dose modification, eye care specialist visits, associated healthcare utilization, and clinical outcomes in patients with relapsed and/or refractory multiple myeloma (RRMM) seen in the Duke Cancer Institute (DCI) clinics.

Real-World Analysis of Belantamab Mafodotin Care Patterns in Patients With Relapsed and/or Refractory Multiple Myeloma

Treatment use and treatment patterns (dose, length of treatment, delays and dose reductions, reasons for discontinuation) will be summarized using proportions.

Number of participants for whom BLENREP dosing was delayed during treatment as categorized by reason.

Number of participants for whom BLENREP dosing was dose reduced during treatment as categorized by reason.

Time (number of days) elapsed from treatment initiation with BLENREP to discontinuation. Descriptive statistics consisting of the mean (± standard deviation\[SD\]) and median (with interquartile range \[IQR\]) will be used to summarize duration across participants.

Number of cycles of treatment with BLENREP to discontinuation. Descriptive statistics consisting of the mean (± standard deviation\[SD\]) and median (with interquartile range \[IQR\]) will be used to summarize duration across participants.

Number of participants who discontinued treatment with BLENREP by reason.

The time from the start of BLENREP treatment until death, with censoring of participants who were alive when last seen or who were lost to follow up.

The percentage of participants with the best overall response: partial response (PR), very good partial response (VFPR), compete response (CR), or stringent complete response (sCR) according to International Myeloma Working Group \[IMWG\] response criteria (if available) or clinician assessment.

The time from the start of BLENREP treatment until the earliest of documented disease progression (according to IMWG response criteria or clinician assessment), end of BLENREP treatment, death, lost to followup or end of study timeframe.

The time from the start of BLENREP treatment to the date of first occurrence of response.

The time from the first date of PR or better to the earliest of documented disease progression, end of BLENREP treatment, death, lost to followup or end of study timeframe.

a. The number of eye exam visits during BLENREP treatment.

Number of participants with specific ocular adverse events of interest (e.g. keratopathy) during treatment with BLENREP

Number of participants receiving treatment for ocular toxicity during BLENREP therapy, as categorized by type of treatment.

Distress is measured on a scale of 0-10 on the NCCN DT. The main outcome variable is the occurrence of actionable distress, defined as a NCCN DT score of 4 or higher. The analysis will describe the proportion of clinic visits where actionable distress is reported during treatment with BLENREP, and the frequency of actionable distress over time.

Sources of distress will be assessed using the NCCN DT Problem List by examining the proportion of visits where types of problems are reported (e.g., physical or emotional problems). The frequency of individual types of problems, and the most commonly-reported problems will be examined descriptively.

To the extent that they are available, HCRU (i.e., inpatient admissions, treatment-related outpatient visits, and emergency department visits) will be summarized by the mean (± SD) and median (with IQR) number of events per patient per year and by the proportion and frequency distribution of patients with any occurrence of the respective outcome. Likewise, mean (± SD) and median (with IQR) length of stay per year will be summarized for inpatient visits.

GlaxoSmithKline

Duke University

Behaviors and Mental Disorders

Quality of Life

Dermatologic Agents

All Drugs and Chemicals

Coal Tar

A concurrent supportive care intervention (intervention arm) Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2).intervention arm will have at least monthly visits with a supportive care clinician

A concurrent supportive care intervention (intervention arm) Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2).intervention arm will have at least monthly visits with a supportive care clinicianTo receive the investigational cancer treatment alone (control arm) no monthly visit with a supportive care clinician.

Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2).

Expectations Survey (CanCORS)

Values Survey (Serious Illness Care Program)

Functional Assessment of Cancer Therapy-General (FACT-G)

NCCN Distress Thermometer

Hospital Anxiety and Depression Scale (HADS)

Quality of Communication (QOC)

Monthly visits with a supportive care clinician

visits with a supportive care clinician

Andrew Epstein, MD

This study will test whether adding personalized supportive care to medical treatment on a clinical trial affects the study participants' ability and desire to discuss their symptoms, their concerns about the future, and their approach to coping with cancer. The effects of supportive care on participants' responses to questions about these topics will be compared with those of other study participants who are being treated for cancer in a clinical trial, but are not receiving personalized supportive care.

Investigating the Impact of Proactive Palliative Care

Evaluating the Impact of Proactive Palliative Care in Patients Initiating Phase I Targeted or Immune-Based Cancer Therapeutics: A Randomized Controlled Trial

using the CanCORS Expectations Survey, which will assess, on a 4-point Likert-type scale, patients' expectations for therapeutic benefit after talking with their doctors about their experimental drug

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Real-World Analysis of Belantamab Mafodotin Care Patterns in Patients With Relapsed and/or Refractory Multiple Myeloma	NCT05986682	Multiple Myelom...	Blenrep	18 Years - 89 Years	Duke University
Investigating the Impact of Proactive Palliative Care	NCT03667378	Metastatic Soli... Locally Advance...	Expectations Su... Values Survey (... Functional Asse... NCCN Distress T... Hospital Anxiet... Quality of Comm... visits with a s...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for nccn distress thermometer