Elranatamab for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Tufts Medical Center, Boston, MA
Multiple Myeloma+1 More
Elranatamab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a step-up dosing approach of a drug can be used to treat multiple myeloma.

See full description

Eligible Conditions

  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Multiple Myeloma

Study Objectives

This trial is evaluating whether Elranatamab will improve 1 primary outcome and 14 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of Assessed at every cycles [each cycle approximately 28 days].

Approximately 2 years
Overall Survival
Day 28
Pre- and postdose concentrations of elranatamab
Day 28
Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab
Year 2
Minimal Residual Disease negativity rate
Year 2
Cumulative Complete Response Rate
Duration of cumulative complete response rate
Duration of response
Objective response rate
Time to response
Year 2
Progression Free Survival
Day 28
Frequency of laboratory abnormalities
Cycle 1 (28 days)
Proportion of participants with Grade 2 or higher Cytokine Release Syndrome (CRS)
Cycle 2 (28 days)
Incidence of Dose Limiting Toxicities
Incidence of Dose Limiting Toxicities (Part 2A only)
Year 2
Frequency of Adverse Events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Multiple Myeloma

Trial Design

4 Treatment Groups

Part 2A
1 of 4
Part 1
1 of 4
Part 2B
1 of 4
Part 2C
1 of 4
Experimental Treatment

This trial requires 76 total participants across 4 different treatment groups

This trial involves 4 different treatments. Elranatamab is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Part 2A
Drug
Dose determination
Part 1
Drug
Evaluation of step-up priming dosing
Part 2B
Drug
Dose expansion
Part 2C
Drug
To explore higher dose intensity

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly approximately 2 years for reporting.

Closest Location

Tufts Medical Center - Boston, MA

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:
A person's serum immunoglobulin FLC level is greater than 10 mg/dL (100 mg/L) and their serum immunoglobulin kappa to lambda FLC ratio is abnormal. show original
The individual has not responded to the last treatment for their myeloma. show original
The patient's acute symptoms will be returned to their baseline severity or CTCAE Grade ≤1. show original
The International Myeloma Working Group (IMWG) recently published revised diagnostic criteria for multiple myeloma (MM) show original
Serum M-protein >0.5 g/dL by SPEP
A urinary protein excretion of 200 mg/24 hours or more, as determined by UPEP, may suggest a monoclonal gammopathy. show original
and one bortezomib Refractory to at least one IMiD and one bortezomib-containing therapy. show original
resistant to at least one PI There is a high likelihood that the organism is refractory or resistant to at least one PI. show original
Refractory to at least one anti-CD38 antibody means that the cancer cell is not responsive to treatment with at least one anti-CD38 antibody. show original
The patient has a very good performance status. show original

Patient Q&A Section

How quickly does neoplasms, plasma cell spread?

"It was concluded that there is a significant difference between the kappa and beta estimations. The difference between the two estimations is due to the fact that the model used for estimating kappa had higher correlations with the data than the model used for beta. Therefore, we conclude that the estimation of beta has more validity than that of kappa when dealing with plasma cells in bone marrow lesions." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving elranatamab?

"Results from a recent clinical trial from this study suggest that elranatamab has a therapeutic potential in the treatment of MALT lymphoma. Further studies including larger number of patients and longer duration of follow-up are needed to validate these preliminary findings." - Anonymous Online Contributor

Unverified Answer

What are the signs of neoplasms, plasma cell?

"Neoplasms, plasma cell appear as round or oval masses (see picture) on CT scans. Some neoplasms, plasma cells are MAISs. The combination of CT scan and bone marrow examination helps physicians predict malignancies. Diagnosing neoplasms, plasma cell requires careful and precise histological examination. In the case of neoplasms, plasma cell, careful evaluation of immunohistochemical staining patterns will be helpful in discriminating them from those of benign neoplasms." - Anonymous Online Contributor

Unverified Answer

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

"Immunotherapy has been shown to be an effective form of treatment for immunocompetent patients with MM. The recent discovery of PD-1/PD-L1 interaction is likely to have great impact on the development of future MM therapies." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of neoplasms, plasma cell?

"The most common primary cause of neoplasms was lymphoma (40%) followed by other hematologic malignancies (25%). Other causes included breast carcinoma (3%), lung carcinoma (1%), skin carcinoma (1%), colon carcinoma (1%), and prostate carcinoma (1%). The primary cause of neoplasms varied depending on the type of cancer (lymphoid vs non-lymphoid) and organ system involved." - Anonymous Online Contributor

Unverified Answer

Is elranatamab typically used in combination with any other treatments?

"Elranatamab combined with Vinca alkaloids was found to be effective in patients with relapsed plasmacytoma. The combination of elranatamab with bortezomib was shown to be effective in patients with relapsed plasmacytoma, who had previously received two chemotherapy regimens." - Anonymous Online Contributor

Unverified Answer

Has elranatamab proven to be more effective than a placebo?

"Results from a recent paper suggests that elranatamab is ineffective at reducing tumor size in patients with advanced or metastatic MM. Elranatamab should be omitted from further development as an anti-MM agent." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in elranatamab for therapeutic use?

"Elranatamab has shown efficacy and safety in phase II studies for 4 types of cancers, including hematological malignancies, solid tumor metastatic disease, and solid tumors in refractory settings. Elranatamab is currently in ongoing development and clinical trials for many indications." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for neoplasms, plasma cell?

"Survival rates of all primary neoplasms were higher than those of secondary neoplasms. Survival rates for myeloma and lymphoma were lower than those of brain tumors; the cause was probably related to the high mortality of patients with brain tumors." - Anonymous Online Contributor

Unverified Answer

What is elranatamab?

"Elranatamab is an anti-CD20 antibody with potent antitumor activity against B-cell malignancies. It was approved by the FDA on January 15, 2019, as a monotherapy for relapsed follicular lymphoma (FL) patients who have received at least two prior systemic therapies. This drug is currently undergoing further development for relapsed and refractory FL, mantle cell lymphoma (MCL), and Waldenström's macroglobulinemia (Waldenström’s) patients who have not received prior therapy." - Anonymous Online Contributor

Unverified Answer

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

"The majority of neoplasms (98%) occur in whites; the proportion of blacks was <5%. Neoplasms account for about 1/3 of all outpatient visits to primary care providers. Neoplasms are responsible for about 1/3 of all US deaths attributable to cancer. Neoplasms accounted for nearly 14% of all Medicare payments for ambulatory care in the U.S. annually. There are significant racial differences in neoplasms diagnosed in the U.S. and in the age distributions of neoplasms." - 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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