Elranatamab for Multiple Myeloma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Ospedale San Martino, Genova, Italy
Multiple Myeloma+1 More
Elranatamab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

See full description

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 Elranatamab will improve 4 primary outcomes and 69 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of From date of first dose of study intervention through minimum of 90 days after last study intervention administration. Reporting of non-serious AEs ends at start of new anti-cancer therapy..

Day 28
Part 1 Safety Lead-In: Rate of Grade ≥2 cytokine release syndrome
Rate of Grade ≥2 cytokine release syndrome
Day 42
Part 1 Safety Lead-In: Incidence of dose limiting toxicities
Month 32
Duration of complete response per International Myeloma Working Group criteria
Duration of cumulative complete response per International Myeloma Working Group criteria
Part 2 Randomized: Duration of cumulative complete response by blinded independent central review per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Part 2 Randomized: Duration of cumulative complete response by blinded independent central review per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Month 32
Part 2 Randomized: Duration of cumulative complete response by investigator assessment per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Part 2 Randomized: Duration of cumulative complete response by investigator assessment per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Month 32
Duration of response per International Myeloma Working Group criteria
Part 2 Randomized: Duration of response by blinded independent central review per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Part 2 Randomized: Duration of response by blinded independent central review per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Part 2 Randomized: Duration of response by investigator assessment per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Part 2 Randomized: Duration of response by investigator assessment per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Month 32
Part 1 Safety Lead-In: Duration of cumulative complete response per International Myeloma Working Group criteria
Month 32
Part 1 Safety Lead-In: Duration of response per International Myeloma Working Group criteria
Day 90
Frequency of abnormal laboratory results
Frequency of treatment-emergent adverse events
Part 1 Safety Lead-In: Frequency of abnormal laboratory results
Part 1 Safety Lead-In: Frequency of treatment-emergent adverse events
Part 2 Randomized: Frequency of abnormal laboratory results
Part 2 Randomized: Frequency of treatment-emergent adverse events
Month 32
Part 1 Safety Lead-In: Time to response per International Myeloma Working Group criteria
Month 32
Part 1 Safety Lead-In: Overall survival
Month 32
Part 1 Safety Lead-In: Progression free survival by investigator assessment per International Myeloma Working Group
Month 32
Part 1 Safety Lead-In: Cumulative complete response rate per International Myeloma Working Group criteria
Part 1 Safety Lead-In: Minimal residual disease negativity rate per International Myeloma Working Group criteria
Part 1 Safety Lead-In: Objective response rate per International Myeloma Working Group criteria
Day 14
Daratumumab pharmacokinetics by pre-dose concentrations
Part 1 Safety Lead-In: Daratumumab pharmacokinetics by pre-dose concentrations
Part 2 Randomized: Daratumumab pharmacokinetics by pre-dose concentrations
Day 14
Elranatamab immunogenicity by anti-drug antibodies against elranatamab
Elranatamab pharmacokinetics by pre- and post-dose concentrations
Part 1 Safety Lead-In: Elranatamab immunogenicity by anti-drug antibodies against elranatamab
Part 1 Safety Lead-In: Elranatamab pharmacokinetics by pre- and post-dose concentrations
Part 2 Randomized: Elranatamab immunogenicity by anti-drug antibodies against elranatamab
Part 2 Randomized: Elranatamab pharmacokinetics by pre- and post-dose concentrations
Day 35
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20
Part 2 Randomized: Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Part 2 Randomized: Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 [elranatamab + daratumumab (Arm B) vs. daratumumab + pomalidomide + dexamethasone (Arm C)]
Part 2 Randomized: Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20 [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Part 2 Randomized: Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20 [elranatamab + daratumumab (Arm B) vs. daratumumab + pomalidomide + dexamethasone (Arm C)]
Month 32
Part 2 Randomized: Time to response by blinded independent central review per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Part 2 Randomized: Time to response by blinded independent central review per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Part 2 Randomized: Time to response by investigator assessment per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Part 2 Randomized: Time to response by investigator assessment per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Time to response per International Myeloma Working Group criteria
Month 32
Part 2 Randomized: Overall survival [elranatamab + daratumumab (Arm B) vs. daratumumab + pomalidomide + dexamethasone (Arm C)]
Month 32
Overall survival
Part 2 Randomized: Overall survival [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Month 32
Part 1 Safety Lead-In: Progression free survival per International Myeloma Working Group criteria
Part 2 Randomized: Progression free survival by investigator assessment per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Part 2 Randomized: Progression free survival by investigator assessment per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Month 32
Complete response rate per International Myeloma Working Group criteria
Cumulative complete response rate per International Myeloma Working Group criteria
Minimal residual disease negativity rate per International Myeloma Working Group criteria
Objective response rate per International Myeloma Working Group criteria
Part 2 Randomized: Cumulative complete response rate by blinded independent central review per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Part 2 Randomized: Cumulative complete response rate by blinded independent central review per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Part 2 Randomized: Cumulative complete response rate by investigator assessment per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Part 2 Randomized: Cumulative complete response rate by investigator assessment per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Part 2 Randomized: Minimal residual disease negativity rate per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Part 2 Randomized: Minimal residual disease negativity rate per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Part 2 Randomized: Objective response rate by blinded independent central review per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Part 2 Randomized: Objective response rate by blinded independent central review per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Part 2 Randomized: Objective response rate by investigator assessment per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Part 2 Randomized: Objective response rate by investigator assessment per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Sustained minimal residual disease negativity rate per International Myeloma Working Group criteria
Month 32
Part 2 Randomized: Progression free survival by blinded independent central review per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)]
Part 2 Randomized: Progression free survival by blinded independent central review per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs. daratumumab + pomalidomide + dexamethasone (Arm C)]
Part 2 Randomized: Progression free survival per International Myeloma Working Group criteria
Month 32
Progression free survival on next-line treatment per International Myeloma Working Group criteria

Trial Safety

Safety Progress

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

Other trials for Multiple Myeloma

Trial Design

4 Treatment Groups

Part 2 Randomized Arm C: Daratumumab + Pomalidomide + Dexamethasone
1 of 4
Part 1 Safety Lead-In Dose Escalation: Elranatamab + Daratumumab
1 of 4
Part 2 Randomized Arm A: Elranatamab
1 of 4
Part 2 Randomized Arm B: Elranatamab + Daratumumab
1 of 4
Active Control
Experimental Treatment

This trial requires 589 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 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Part 1 Safety Lead-In Dose Escalation: Elranatamab + Daratumumab
Part 2 Randomized Arm A: Elranatamab
Drug
Part 2 Randomized Arm B: Elranatamab + Daratumumab
Part 2 Randomized Arm C: Daratumumab + Pomalidomide + Dexamethasone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hyaluronidase (human recombinant)
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from date of randomization to date of confirmed objective response, assessed up to 32 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from date of randomization to date of confirmed objective response, assessed up to 32 months for reporting.

Closest Location

Cross Cancer Institute - Edmonton, Canada

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 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Prior diagnosis of multiple myeloma as defined by IMWG criteria (Rajkumar et al, 2014).
Serum M-protein ≥0.5 g/dL.
Urinary M-protein excretion ≥200 mg/24 hours.
Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
Prior anti-multiple myeloma therapy including treatment with lenalidomide and a proteasome inhibitor.
ECOG performance status ≤2.
Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
Not pregnant and willing to use contraception.

Patient Q&A Section

Does elranatamab improve quality of life for those with multiple myeloma?

"Patients treated with elranatamab had better QOL, including improvements in pain control, fatigue, and MIPQ, compared with placebo. Elranatamab had no effect on immunoglobulin levels." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating multiple myeloma?

"There have been many important advances made in our understanding of MM biology and treatment over the past decade. However, despite these methodological advancements, patient survival remains suboptimal and optimal therapy still needs to be determined." - Anonymous Online Contributor

Unverified Answer

Is elranatamab typically used in combination with any other treatments?

"Elranatamab is commonly used alone or in combination with other drugs; however, no clinical trial has investigated its use in combination with bortezomib in the treatment of multiple myeloma. The phase III ONO-AFFIRM trial found significant improvement in PFS and OS when elranatamab was added to bortezomib plus dexamethasone." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of elranatamab?

"The most common adverse events were headache (14%), fatigue (11%), nausea (10%), dizziness (9%), dry mouth (8%), constipation (6%), injection site reactions (3%) and rash (2%). There was no incidence of hypertriglyceridaemia, hepatitis, pneumonitis or hypersensitivity reaction." - Anonymous Online Contributor

Unverified Answer

What are common treatments for multiple myeloma?

"The majority of people with MM receive some type of chemotherapy. More than two thirds of people have this treatment before they reach their 2 year endpoint. Most will receive either [thalidomide (Thalomid)] or lenalidomide (Revlimid), both of which have been shown to improve overall survival. There is no clear evidence that one agent is better than another for people in early stages of MM. People with advanced MM may benefit from [thalidomide] and those with higher risk of refractoriness from previous chemotherapy may benefit from lenalidomide. There is little evidence whether different regimens work differently in people with MM." - Anonymous Online Contributor

Unverified Answer

What is elranatamab?

"Elranatamab was well tolerated as an adjuvant therapy in patients with high risk MM who had received two prior lines of therapy. Median PFS and OS were de facto not reached due to early termination of the study. The most common adverse events were fatigue, headache, nausea, vomiting, diarrhoea, rash, and infusion related reactions. There were no serious adverse events associated with elranatamab. Elranatamab is a novel immunomodulatory agent that shows promise for improving prognosis in high risk MM patients treated with bortezomib, lenalidomide, dexamethasone, and cyclophosphamide." - Anonymous Online Contributor

Unverified Answer

Is elranatamab safe for people?

"Elranatamab was generally well tolerated In a recent study, but there were a few transient grade 3/4 adverse events associated with infusion. These include nausea, vomiting, headache, dizziness, fatigue, and paraesthesia (pins and needles), which occurred most often during the first infusion. Longer terms safety data are awaited." - Anonymous Online Contributor

Unverified Answer

Does multiple myeloma run in families?

"The present data provide no evidence for an increased prevalence of MM in family members. We cannot exclude a possible association between MM and other hereditary disorders; however, our data do not support a hereditary etiology for MM." - Anonymous Online Contributor

Unverified Answer

What are the signs of multiple myeloma?

"A self-reported history of bone pain during a physical exam was found to be the best indicator of MM diagnosis. Other physical findings were suggestive of MM, but lacked specificity. The presence of bone lesions and/or anemia were not specific for MM. Only the presence of an elevated serum paraprotein (a protein in the blood) confirmed the diagnosis of MM." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for multiple myeloma?

"In a recent study, the overall survival was not indicative of the survival rates for either myeloma or AL amyloidosis; however, myeloma had a better outcome than AL amyloidosis." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing multiple myeloma?

"[The chances of developing MM are low unless you have an inherited genetic predisposition to develop the disease.] In contrast, the probability of developing other hematological cancers increases substantially [(figure 1)] if you are Caucasian. [Body figure] Ethnicity does not appear to be a risk factor for the development of non-Hodgkin’s lymphoma, acute myeloid leukemia, chronic lymphocytic leukemia, or polycythemia vera." - 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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