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Elranatamab in R/R Multiple Myeloma

ConditionsRefractory Multiple MyelomaRelapse Multiple MyelomaMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

This research is being done to see if the study drug, elranatamab, reduces the risk of disease progression (worsening disease) after idecabtagene vicleucel in relapsed refractory multiple myeloma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant has given voluntary signed written informed consent before performance of any study related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to their future medical care.

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.

Male or female participants age ≥ 18 years

The effects of elranatamab on the developing human fetus are unknown. For this reason and because anti-BCMA bispecific antibodies are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of elranatamab administration.

Disqualifiers

Patients with smoldering MM, plasma cell leukemia, POEMS syndrome, or amyloidosis are excluded from this trial.

Stem cell transplant within 12 weeks prior to enrollment or active graft-versus-host disease (GVHD).

Active hepatitis B virus, hepatitis C virus, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), HIV, or any active, uncontrolled bacterial, fungal, or viral infection. Active infections must be resolved at least 14 days prior to enrollment.

Acute myocardial infarction or acute coronary syndromes (eg, unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, symptomatic pericardial effusion);

Trial design

Design model

Single group

Treatments tested in this trial

  • Elranatamab

    Drug

    subcutaneous (under the skin) injection

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: ElranatamabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Complete Response (CR) rate or stringent CR (sCR) post consolidation therapy

Disease response will be assessed using the International Myeloma Working Group Response Criteria (IMWG)

Time frame
The time from start of treatment to first date that progressive disease is objectively documented or death due to any cause, for up to 5 years. Participants without events reported are censored at the last disease evaluation.
2

Progression-free survival

Progression-Free Survival (PFS) is defined as the time from or registration to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. This will be estimated with the Kaplan-Meier method and summarized with medians and 95% confidence intervals.

Time frame
The time from registration to the earlier of progression or death due to any cause, for up to 5 years. Participants alive without disease progression are censored at date of last disease evaluation

Secondary outcomes

1

Incidence of adverse events (AEs)

Adverse events will be evaluated using CTCAE version 5

Time frame
3 years
2

Objective response rate (ORR)

ORR will be evaluated using the IMWG Uniform Response criteria

Time frame
From start of treatment to 2 years post-treatment
3

Overall survival (OS)

Overall Survival (OS) is defined as the time from or registration to death due to any cause, or censored at date last known alive. Estimated with the Kaplan-Meier method and summarized with medians and 95% confidence intervals.

Time frame
From start of treatment to 2 years post-treatment
4

Minimum Residual Disease (MRD)-positive to MRD-negative conversion rate

MRD-positive to MRD-negative conversion rate is the proportion of MRD-positive participants that become MRD-negative. Point estimates of MRD positivity and negativity rates will be calculated along with the 2-sided 95% CIs using the Clopper-Pearson method.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Pfizer

Collaborator

Source ClinicalTrials.gov
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