Pomalidomide for Recurrent Plasma Cell Myeloma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
OHSU Knight Cancer Institute, Portland, OR
Recurrent Plasma Cell Myeloma+3 More
Pomalidomide - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of three drugs may be more effective than a single drug in treating patients with multiple myeloma.

See full description

Eligible Conditions

  • Recurrent Plasma Cell Myeloma
  • Refractory Plasma Cell Myeloma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Pomalidomide will improve 1 primary outcome, 5 secondary outcomes, and 1 other outcome in patients with Recurrent Plasma Cell Myeloma. Measurement will happen over the course of Up to 30 days after discontinuing study treatment.

Month 24
Frequency of minimal residual disease negative remissions at time of complete response
Month 24
Duration of response (DOR)
Month 24
Time to next treatment
Month 24
Overall survival
Month 24
Progression-free survival
Day 30
Incidence of grade > 2 toxicities
Day 28
Overall response rate (ORR)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

1 Treatment Group

Treatment (isatuximab, carfilzomib, pomalidomide)
1 of 1
Experimental Treatment

This trial requires 44 total participants across 1 different treatment group

This trial involves a single treatment. Pomalidomide 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 2 and have already been tested with other people.

Treatment (isatuximab, carfilzomib, pomalidomide)Patients receive isatuximab IV over 30-60 minutes on days 1, 8, 15, and 22 of cycle 1, and days 1 and 15 of subsequent cycles, carfilzomib IV over 10 to 30 minutes on days 1, 8, 15, and pomalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carfilzomib
FDA approved
Isatuximab
FDA approved
Pomalidomide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from start of study treatment until death or last known alive (censored), assessed up to 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from start of study treatment until death or last known alive (censored), assessed up to 24 months for reporting.

Who is running the study

Principal Investigator
R. W. S.
Rebecca W. Silbermann, Principal Investigator
OHSU Knight Cancer Institute

Closest Location

OHSU Knight Cancer Institute - Portland, OR

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Recurrent Plasma Cell Myeloma or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The text describes a medical condition, multiple myeloma show original
The individual has either not responded to the last treatment they were given, their disease has progressed whilst on treatment, or their disease has progressed within 60 days of them stopping treatment. show original
of proteasome inhibitor People who have taken proteasome inhibitors in the past are allowed to participate in the study, but they must stop taking the proteasome inhibitors at least two weeks before the study begins. show original
A monoclonal immunoglobulin spike on serum protein electrophoresis of >= 0.5 g/dL is a sign of multiple myeloma. show original
The patient has a urine monoclonal immunoglobulin spike of >= 200 mg/24 hours. show original
People who want to take part in the study must be at least 18 years old. show original
of IMiD People who have previously taken immunomodulatory imide drugs (lenalidomide, pomalidomide, or thalidomide) are allowed to take the new drug, but they must wait 2 weeks after their last dose of the old drug. show original
Before any study specific procedures or interventions are performed, the participant or legally authorized representative must provide written informed consent. show original
The participant has received treatment with at least one line of therapy in the past. show original
of anti-CD38 therapy People who have received treatment with anti-CD38 therapy in the past are allowed to participate in this study, but they must wait six months after their last dose of anti-CD38 therapy before they can join the study. show original

Patient Q&A Section

What is neoplasms, plasma cell?

"Nephrotic syndrome is characterized by an imbalance between protein synthesis and protein catabolism. This leads to a decrease in water and sodium excretion. Excessive proteinuria leads to an increase in plasma protein levels. Hypervolemia and volume contraction also cause proteinuric nephritic syndrome." - Anonymous Online Contributor

Unverified Answer

What are the signs of neoplasms, plasma cell?

"There is a high likelihood of having a neoplasm in cases of plasma cell disease that can cause bone and joint complaints. In addition, there is a high likelihood of having a myeloma with bone and joint complaints even if there have never been any signs of bone pain. Bone, joint, and muscle pain in a patient with plasma cell and no detectable calcium levels should be investigated and a specific diagnostic test should be performed." - Anonymous Online Contributor

Unverified Answer

What causes neoplasms, plasma cell?

"Although there is no agreement, neoplasms are thought to emerge from a plasma cell origin. This is most likely after multiple exposures to neoplastic polyclonal and monoclonal germline genetic or environmental stimuli. Neoplasms arise from neoplastic germline mutations or somatic hypermutation or from epigenetic and microenvironment-related factors. Neoplasts are not generated by simple proliferation. Neoplasms are mostly neoplastic cells that derive from germinal center precursor cells or from neoplastic plasma cells. Neoplastic plasmacytes are not simply immortalized neoplastic B cells or Hodgkin lymphoma cells of germinal center origin." - Anonymous Online Contributor

Unverified Answer

How many people get neoplasms, plasma cell a year in the United States?

"There is an increased risk for neoplasms among persons with neoplasms and PLTs on the United States Veterans Health Administration primary and secondary databases of which the last is a nationally acclaimed nationwide quality of care health care system with more than 200,000 members; the first is a nationwide comprehensive health care system of which the primary focus is providing the most people and, thus, the greatest likelihood for detecting and treating cancers and PLTs." - Anonymous Online Contributor

Unverified Answer

Can neoplasms, plasma cell be cured?

"Neoplasms can be cured; we may not be able to prevent neoplasms, but we may be able to prevent many of the more life-threatening complications of neoplasms, plasma cell leukemias, and nonneoplastic diseases." - Anonymous Online Contributor

Unverified Answer

What are common treatments for neoplasms, plasma cell?

"Many treatments are used as part of an individual patient's treatment regimen that helps to optimize their outcome. Common treatments include chemotherapy, radiation therapy, surgery, targeted therapy, and monoclonal antibody therapy." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating neoplasms, plasma cell?

"There have been some promising findings for the first-line treatment of myeloma and non-Hodgkin disease. Further development of new agents and clinical trials may provide new options for patients who would benefit from a new and effective treatment." - Anonymous Online Contributor

Unverified Answer

Does pomalidomide improve quality of life for those with neoplasms, plasma cell?

"Results from a recent paper of patients with MM, pomalidomide at the recommended dose of 20mg twice a day had a minimal effect on disease control and treatment-related symptoms. However, it significantly improved overall QoL. Physicians evaluating MM patients should consider pomalidomide to improve the quality of life for patients with MM." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for neoplasms, plasma cell?

"Survival data should be considered [reference needed for further information][reference needed for further information] as it is not clear if there is a difference in survival between these patients and neoplasms, plasma cell. Additionally, there is no information on the treatment or management of these patients." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in pomalidomide for therapeutic use?

"This year has seen several developments in the use of pomalidomide for all types of lymphoid malignancies. These include an increased dose, new indications/routes of administration, improved safety data, and new indications/routes of administration. Overall, the safety and efficacy data support accelerated approval of pomalidomide for a variety of treatment types for all forms of lymphoid malignancies. Power lets you find recent pomalidomide clinical trials by type/condition/location." - Anonymous Online Contributor

Unverified Answer

Is pomalidomide typically used in combination with any other treatments?

"Findings from a recent study suggest that pomalidomide may be very useful as an adjuvant, postoperative, and induction therapy in MM. However, because of the lack of data about pomalidomide-associated toxicities in this population, use of pomalidomide in combination with other agents, or as a monotherapy regimen, should be further investigated." - Anonymous Online Contributor

Unverified Answer

Is pomalidomide safe for people?

"Pomalidomide is a safe immunomodulatory drug for people with relapsed and naïve PCL. It is well tolerated, with an overall response rate comparable to that of single agent lenalidomide." - Anonymous Online Contributor

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