CLINICAL TRIAL

ONC201 for Multiple Myeloma

1 Prior Treatment
Refractory
Relapsed
Waitlist Available · 18+ · All Sexes · Philadelphia, PA

This study is evaluating whether a drug called ONC201 can be used to treat multiple myeloma.

See full description

About the trial for Multiple Myeloma

Eligible Conditions
Neoplasms, Plasma Cell · Multiple Myeloma

Treatment Groups

This trial involves 2 different treatments. ONC201 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
ONC201
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ONC-201
Not yet FDA approved

Side Effect Profile for Cohort 1-Hormone Receptor (HR) + Breast Cancer (Male and Female)

Cohort 1-Hormone Receptor (HR) + Breast Cancer (Male and Female)
Show all side effects
57%
Anorexia
57%
Aspartate aminotransferase increased
43%
Fatigue
43%
Alanine aminotransferase increased
43%
Constipation
43%
Nausea
43%
Lymphocyte count decreased
43%
Vomiting
29%
Alkaline phosphatase increased
29%
Diarrhea
29%
Fever
29%
Anemia
29%
Blood bilirubin increased
29%
Pain
29%
Proteinuria
14%
Dyspepsia
14%
Fall
14%
Dehydration
14%
Dizziness
14%
Dyspnea
14%
Wheezing
14%
Hypermagnesemia
14%
Dysarthria
14%
Edema limbs
14%
Myalgia
14%
Peripheral sensory neuropathy
14%
Pruritus
14%
Lethargy
14%
Facial pain
14%
Ascites
14%
Urinary tract infection
14%
White blood cell decreased
14%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Death
14%
Abdominal pain
14%
Tremor
14%
Transient ischemic attacks
14%
Cough
14%
Dysgeusia
14%
Epistaxis
14%
Flu like symptoms
14%
Hyperhidrosis
14%
Hypoalbuminemia
14%
Malaise
14%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
14%
Laryngeal hemorrhage
14%
Non-cardiac chest pain
14%
Pain in extremity
14%
Platelet count decreased
14%
Pleural effusion
14%
Upper respiratory infection
14%
Weight loss
0%
Stroke
0%
Hypomagnesemia
0%
Sinus tachycardia
0%
Vaginal hemorrhage
0%
Creatinine increased
0%
Headache
0%
Cardiac arrest
0%
Abdominal distension
0%
Back pain
0%
Thromboembolic event
0%
Flushing
0%
Gastroesophageal reflux disease
0%
Confusion
0%
Nervous system disorders - Other, Balance issues
0%
Breast pain
0%
Arthralgia
0%
Vascular access complication
0%
Tumor hemorrhage
0%
Hypocalcemia
0%
Insomnia
0%
Atrial flutter
0%
Pneumonitis
0%
Sepsis
0%
Lymphedema
0%
Hot flashes
0%
Hypophosphatemia
0%
Hypotension
0%
Paresthesia
0%
Memory impairment
0%
Mucosal infection
0%
Rash maculo-papular
0%
Rhinorrhea
0%
Vaginal discharge
Anorexia
57%
Aspartate aminotransferase increased
57%
Fatigue
43%
Alanine aminotransferase increased
43%
Constipation
43%
Nausea
43%
Lymphocyte count decreased
43%
Vomiting
43%
Alkaline phosphatase increased
29%
Diarrhea
29%
Fever
29%
Anemia
29%
Blood bilirubin increased
29%
Pain
29%
Proteinuria
29%
Dyspepsia
14%
Fall
14%
Dehydration
14%
Dizziness
14%
Dyspnea
14%
Wheezing
14%
Hypermagnesemia
14%
Dysarthria
14%
Edema limbs
14%
Myalgia
14%
Peripheral sensory neuropathy
14%
Pruritus
14%
Lethargy
14%
Facial pain
14%
Ascites
14%
Urinary tract infection
14%
White blood cell decreased
14%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Death
14%
Abdominal pain
14%
Tremor
14%
Transient ischemic attacks
14%
Cough
14%
Dysgeusia
14%
Epistaxis
14%
Flu like symptoms
14%
Hyperhidrosis
14%
Hypoalbuminemia
14%
Malaise
14%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
14%
Laryngeal hemorrhage
14%
Non-cardiac chest pain
14%
Pain in extremity
14%
Platelet count decreased
14%
Pleural effusion
14%
Upper respiratory infection
14%
Weight loss
14%
Stroke
0%
Hypomagnesemia
0%
Sinus tachycardia
0%
Vaginal hemorrhage
0%
Creatinine increased
0%
Headache
0%
Cardiac arrest
0%
Abdominal distension
0%
Back pain
0%
Thromboembolic event
0%
Flushing
0%
Gastroesophageal reflux disease
0%
Confusion
0%
Nervous system disorders - Other, Balance issues
0%
Breast pain
0%
Arthralgia
0%
Vascular access complication
0%
Tumor hemorrhage
0%
Hypocalcemia
0%
Insomnia
0%
Atrial flutter
0%
Pneumonitis
0%
Sepsis
0%
Lymphedema
0%
Hot flashes
0%
Hypophosphatemia
0%
Hypotension
0%
Paresthesia
0%
Memory impairment
0%
Mucosal infection
0%
Rash maculo-papular
0%
Rhinorrhea
0%
Vaginal discharge
0%
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03394027) in the Cohort 1-Hormone Receptor (HR) + Breast Cancer (Male and Female) ARM group. Side effects include: Anorexia with 57%, Aspartate aminotransferase increased with 57%, Fatigue with 43%, Alanine aminotransferase increased with 43%, Constipation with 43%.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Multiple Myeloma or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients must be refractory to, or not a candidate for, established therapy known to provide clinical benefit for their malignancy.
Measurable disease M protein component in serum (at least 0.5 g/dL) and/or urine (if present) (>=0.2 g excreted in a 24 hour collection sample).
All previous therapies for cancer, including radiotherapy, major surgery and investigational therapies discontinued for ≥ 14 days (≥ 28 days for mitomycin C or nitrosoureas) before study entry, and all acute effects of any prior therapy resolved to baseline severity or Grade ≤ 1 Common Terminology Criteria for Adverse Events (CTCAE v4.03), except alopecia or parameters defined in this eligibility list.
Age ≥ 18 years.
ECOG performance status ≤ 1.
Absolute neutrophil count ≥1,000/mm3 without growth factor use ≤ 7 days prior to treatment (cycle 1 day 1, C1D1)
Platelets ≥75,000/mm3 without platelet transfusion ≤ 3 days prior to C1D1
Hemoglobin >8.0 mg/dL without red blood cell transfusion ≤ 3 days prior to C1D1
Total serum bilirubin <1.5 X upper limit of normal (ULN)
AST (SGOT)/ALT (SGPT) ≤2 X ULN; ≤ 5 X ULN if there is liver involvement secondary to tumor Serum creatinine ≤ 1.5 X ULN (OR creatinine clearance ≥ 60 mL/min/1.73 m2)
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 3 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 3 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether ONC201 will improve 1 primary outcome in patients with Multiple Myeloma. Measurement will happen over the course of 3 years.

Overall response rate
3 YEARS
Best overall response
3 YEARS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes multiple myeloma?

It is a common misconception that the myeloma protein is the primary agent that causes myeloma, but a combination of environmental factors and genetic predisposition play key roles in the development of multiple myeloma, as well as in multiple myeloma progression.

Anonymous Patient Answer

Can multiple myeloma be cured?

Multiple myleoma is a very incurable disease in the absence of effective therapy. It can be effectively treated by treatment aimed at improving the quality of life and the function of cancer-related symptoms.

Anonymous Patient Answer

What are common treatments for multiple myeloma?

The most frequent medications used to treat MM are bortezomib, thalidomide, lenalidomide, dexamethasone, and melphalan. The most common treatments used to treat relapsed cases of MM are thalidomide and dexamethasone alone. There is a lot more variation in the use of therapies to manage MM, which may result in sub-optimal effectiveness of treatment. More investigation of treatments used in the field is needed.

Anonymous Patient Answer

How many people get multiple myeloma a year in the United States?

About 85,000 people in the United States develop multiple myeloma a year. Most of them are male, have a low body mass index, or have had multiple myeloma for 5 yr or more before diagnosis.

Anonymous Patient Answer

What is multiple myeloma?

The most common type of blood cancer multiple myeloma is a cancer of the bone marrow and spine. Symptoms include bone pain, easy bruising and bleeding, low red blood cell levels, low white blood cell and platelet counts, and low neutrophil levels.\n

Anonymous Patient Answer

What are the signs of multiple myeloma?

Signs of [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) may be present when there is a decrease of bone marrow mass (anemia) or when the white blood cell count is less than 15X107/L or when osteoclastic resorption is suspected. In addition to these signs of myeloma, there are signs that are specific for this disease: kidney failure, hepatomegaly, low albumin, an elevated blood calcium or high bone serum levels. A bone marrow biopsy is the only way to confirm the diagnosis of myeloma.

Anonymous Patient Answer

Have there been other clinical trials involving onc201?

One trial, namely, the VEGITRAE trial, has not yet been done, but onc201 is being evaluated for two other cancers: (1) renal cancer by OCCASUS and (2) hepatocellular carcinoma by JUNQUS. We feel that it is unlikely onc201 will be as useful for the two former indications as it is for cancer immunotherapy.

Anonymous Patient Answer

What is the survival rate for multiple myeloma?

Although the survival rate of MM is still poor, many patients still live long enough to [survive until the fifth year of survivorship after diagnosis.] Patients with myeloma are at an increased risk of developing various other cancers.

Anonymous Patient Answer

What is the primary cause of multiple myeloma?

It is concluded that in the majority of cases, the primary (initial) MM has not been properly elucidated. Therefore, it is very valuable to determine the primary tumor to develop new effective treatment against this disease. A multidisciplinary approach to treat patients with multiple myeloma is recommended.

Anonymous Patient Answer

What are the latest developments in onc201 for therapeutic use?

The number of reported clinical trials increased in recent years. This represents a growing need for a strong evidence base to support the use of new agents for the disease.

Anonymous Patient Answer

Is onc201 typically used in combination with any other treatments?

The addition of onc201 to other chemotherapy regimens results in a higher response rate, overall survival and progression-free survival and could potentially prove to be a feasible strategy. However, further studies, with a randomization design, are needed to confirm the reported results in a larger number of patients.

Anonymous Patient Answer

What are the chances of developing multiple myeloma?

There is a high likelihood (89%) of developing a pre-malignant condition within the first 5years after diagnosis of MM, and more than 10 years after diagnosis, there is a significant risk of developing MM. A combination of age, time from diagnosis of MM, and treatment type are most strongly linked to the development of MM in older patients. Given the growing numbers of patients treated for MM and their increased age, it is important to monitor the progression of pre-malignant conditions such as ALT, and the development of MM in elderly patients.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Multiple Myeloma by sharing your contact details with the study coordinator.