Pomalidomide for Multiple Myeloma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
East Carolina University, Greenville, NC
Multiple Myeloma+1 More
Pomalidomide - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

A Study of Combination of Selinexor, Pomalidomide, and Dexamethasone (SPd) Versus Elotuzumab, Pomalidomide, and Dexamethasone (EloPd) in Subject With Previously Treated Multiple Myeloma

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Eligible Conditions

  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Multiple Myeloma

Study Objectives

This trial is evaluating whether Pomalidomide will improve 1 primary outcome and 9 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of continuously from screening untill 30 days after last study treatment. (approximately up to 2 years).

Year 3
Overall survival (OS)
Year 2
safety and tolerability of SPd versus EloPd in patients with RRMM
Year 5
Progression-free survival (PFS)
Year 2
Overall Response Rate (ORR)
Year 2
Change in EORTC QLQ- 20-item Multiple Myeloma module (MY-20) score and the difference between-treatment arms
EQ-5D-5L health utility values and the difference between-treatment arms
Year 2
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core module (EORTC QLQ-C30) score and the difference between-treatment arms
Year 3
Duration of response
Time to response
Year 5
Progression-free survival on the next line of therapy (PFS2)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Multiple Myeloma

Trial Design

2 Treatment Groups

Elotuzumab, Pomalidomide and Dexamethasone (EloPd)
1 of 2
Selinexor, pomalidomide and dexamethasone (SPd)
1 of 2
Active Control
Experimental Treatment

This trial requires 300 total participants across 2 different treatment groups

This trial involves 2 different treatments. 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 3 and have had some early promising results.

Selinexor, pomalidomide and dexamethasone (SPd)Selinexor will be given as an oral dose 40 mg (2 20 mg tablets) or 60 mg (3 20 mg tablets) once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle. Pomalidomide will be given as an oral 4 mg dose QD on Days 1 to 21 of each 28-day cycle. Patients ≤75 years: o Dexamethasone will be given as an oral 40 mg dose QW on Days 1, 8, 15, and 22 of each 28-day cycle. Dose may be divided over 2 days at the Investigator's discretion. Patients > 75 years: Dexamethasone will be given as an oral 20 mg dose QW on Days 1, 8, 15, and 22 of each 28-day cycle. Dose may be divided over 2 days at the Investigator's discretion.
Elotuzumab, Pomalidomide and Dexamethasone (EloPd)Elotuzumab will be given IV 10 mg/kg on Days 1, 8, 15, and 22 of cycle 1 and 2 then 20 mg/kg on Day 1 of cycles ≥3 of each 28-day cycle. Pomalidomide will be given as an oral 4 mg dose once a day (QD) on Days 1 to 21 of each 28-day cycle. Patients ≤75 years: Dexamethasone 28 mg PO + 8 mg IV on days of elotuzumab dosing Dexamethasone 40 mg PO on non-elotuzumab days (e.g., days 8, 15, and 22 of cycle 3 and beyond). Dose may be divided over 2 days at the Investigator's discretion. Patients >75 years: Dexamethasone 8 mg PO + 8 mg IV on days of elotuzumab dosing Dexamethasone 20 mg PO on non-elotuzumab dosing weeks (e.g., days 8, 15, and 22 of cycle 3 and beyond). Dose may be divided over 2 days at the Investigator's discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pomalidomide
FDA approved
Selinexor
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from randomization to the date of disease progression or death (approximately up to 5 years)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from randomization to the date of disease progression or death (approximately up to 5 years) for reporting.

Closest Location

East Carolina University - Greenville, NC

Eligibility Criteria

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.

Mark “yes” if the following statements are true for you:
Serum M-protein ≥0.5 g/dL (≥5 g/L) by serum protein electrophoresis (SPEP) or, for immunoglobulin (Ig) A or D myeloma, by quantitative serum IgA or IgD levels ≥ 0.5 g/dL.
Urinary M-protein excretion ≥200 mg/24 hours
Serum free light chain (FLC) ≥100 mg/L, provided that the FLC ratio is abnormal (normal FLC ratio: 0.26 to 1.65)
Received at least 1 and no more than 4 prior anti-MM lines of therapy. Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy.
Patients must have prior therapy which must include an anti-CD3 mAb, and ≥2 consecutive cycles of the following agents given alone or in combinations: lenalidomide, proteasome inhibitor.
Received anti-CD38 mAb as their immediate last treatment prior to study entry (50% of patients)
Received prior anti-CD38 mAb other than in immediate last treatment prior to study entry (50% of patients)
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
Resolution of any clinically significant non-hematological toxicities (if any) from previous treatments to Grade ≤1 by Cycle 1 Day 1 (C1D1). Patients with Grade 2 non-hematological toxicities may be included following approval from the Medical Monitor.
Total bilirubin <2 × upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of <3 × ULN)

Patient Q&A Section

What are common treatments for multiple myeloma?

"A very wide range of treatments is available for multiple myeloma, from palliative therapies to potentially curative treatments. Although some of these treatments do not appear to shorten survival, most will help to extend survival for patients whose disease has proved to be resistant to earlier therapies." - Anonymous Online Contributor

Unverified Answer

Can multiple myeloma be cured?

"Early diagnosis and effective treatment enables the majority of patients with MM to achieve a long remission and maintain disease-free survival. The overall survival of patients with advanced or high-risk subtypes of MM remains poor, but can at most be improved." - Anonymous Online Contributor

Unverified Answer

What are the signs of multiple myeloma?

"Symptoms of bone pain, constipation, hematuria/blood in urine, microscopic or macroscopic haemorrhage, anemia, thrombocytosis\nor leukocytosis are not specific signs of [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma). However, fever with erythrocyte sedimentation rate over 100, paraproteinaemia and/or immunoglobulinaemia constitute good indicators of myeloma." - Anonymous Online Contributor

Unverified Answer

What causes multiple myeloma?

"There is considerable variation in the types of myeloma found in different regions, but multiple myeloma does not appear to result from any single environmental or genetic factor. However, there may be a risk factor associated with the development of MM; further studies are needed." - Anonymous Online Contributor

Unverified Answer

What is multiple myeloma?

"Multiple myeloma is a disease in which excess or abnormal immune cells, including immunoglobulin-secreting plasma cells, are formed. As these cells reproduce and differentiate in bone marrow, multiple myeloma develops. It typically forms in the elderly, but can occur at any age. The underlying cause is not known, but the disease appears to be initiated by environmental factors. Many conditions or other risk factors have been linked with the development of multiple myeloma. The risk is higher than that of cancer in general for people with multiple myeloma; the five-year survival rate for men with multiple myeloma is 36% to 40%, about half that of men with breast cancer." - Anonymous Online Contributor

Unverified Answer

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

"Only about half of the newly diagnosed patients with myeloma get all of the required treatment in the first year and approximately one in eight of patients with multiple myeloma die in the first and second years after diagnosis. The main causes of death are other diagnoses and cancer-related causes. Improved medical management and adherence may help improve the long-term survival of patients with multiple myeloma." - Anonymous Online Contributor

Unverified Answer

Does multiple myeloma run in families?

"A modest number of multiple myeloma cases are thought to be familial, but there is no strong evidence that they have an identifiable genetic basis and in many cases, no significant association has been shown with shared family features. The association of multiple myeloma with a single HLA-DRB1 allele and the existence of a distinct multiple myeloma variant may be suggestive of a genetic or environmental link, although the exact pathology of these variants is not known." - Anonymous Online Contributor

Unverified Answer

What does dexamethasone oral usually treat?

"Dexamethasone orally is effective for the treatment of a substantial portion of patients in the first few years after diagnosis with multiple myeloma. Dexamethasone is an effective adjunct therapy in patients with symptomatic and newly diagnosed multiple myeloma." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of dexamethasone oral?

"About one-third (23.2%), one-third (23.2%), and one-third (21.9%) of the patients experienced side effects after the first, second, and third doses, respectively. Most side effects disappeared within the first month of use. The most common side-effect was nausea (6.5%) with two-thirds (66.5%) occurring after the first dose. The most common other side effects were dizziness (9.8%), and weakness (7.8%) after the second and third doses, respectively. None of the side effects were severe, fatal, or long lasting." - Anonymous Online Contributor

Unverified Answer

How serious can multiple myeloma be?

"We show for the first time that patients with MM receiving autologous stem cell [transplant](https://www.withpower.com/clinical-trials/transplant)ation in first complete remission have similar survival and remission rates as previously published reports. In the era of more effective MM treatment, autologous stem cell transplantation should not be withheld unless absolutely necessary in patients who have not responded to other MM treatments." - Anonymous Online Contributor

Unverified Answer

Has dexamethasone oral proven to be more effective than a placebo?

"A 3-month course of dexamethasone oral has proven effective for the first-line treatment of multiple myeloma in clinical trials. Dexamethasone oral is recommended as an initial monotherapy for multiple myeloma." - 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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