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Pilot Study Using Changes in Serum BCMA to Determine Disease Progression in Multiple Myeloma

ConditionMultiple Myeloma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOncotherapeutics

About this trial

This is a phase 1, multicenter, open-label study evaluating the safety and efficacy of ruxolitinib, steroids and lenalidomide among MM patients who currently show progressive disease using BCMA to test progression.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects must meet all the following inclusion criteria to be eligible to enroll in this study.

Plasmacytomas on tissue biopsy

BM plasmacytosis (greater than 30% plasma cells)

Monoclonal immunoglobulin spike on serum electrophoresis IgG greater than 3.5 g/dL or IgA greater than 2.0 g/dL or kappa or lambda light chain excretion greater than 1 g/day on 24-hour urine protein electrophoresis

Disqualifiers

POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)

Plasma cell leukemia (> 2.0 × 109/L circulating plasma cells by standard differential)

Primary amyloidosis

Non-hematologic malignancy within the past 5 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas

Trial design

Design model

Sequential

Treatments tested in this trial

  • Ruxolitinib Oral Tablet [Jakafi]

    Drug

    Ruxolitinib will be administered on days 1-28 of the treatment cycle.

  • Lenalidomide

    Drug

    Lenalidomide will be administered on Days 1-21 of the treatment cycle.

  • Methylprednisolone

    Drug

    Methyl-prednisolone will be administered on Days 1-28 of the treatment cycle.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Rux + SteroidExperimental treatment 2 interventions
Group B: Rux + Steroid + LenExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Time to Disease Progression (TTP)

* To establish the utility of using an increase in sBCMA levels \> 25% or IMWG criteria for disease progression to direct this therapeutic approach, TTP will be measured, where TTP is defined as a number of days between the start of treatment (cycle 1 day 1) and PD. PD is defined by either change in sBCMA (≥25% increase from its nadir levels) or by standard IMWG criteria (using sM-protein and SFLC assessments), whichever occurs first. PD will be confirmed by two consecutive tests. * Duration of response 1 (DOR1), defined as the time from the first response to progressive disease as determined by either changes in sBCMA or IMWG criteria (whichever occurs first) while patients are on ruxolitinib and methylprednisolone treatment * Duration of response 2 (DOR2), defined as the time from the first response to progressive disease as determined by standard IMWG criteria while patients on ruxolitinib, lenalidomide and methylprednisolone treatment

Time frame
54 months

Secondary outcomes

1

Safety and Tolerability

• Occurrence of adverse events throughout the study, graded via Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 criteria

Time frame
54 months
2

Efficacy and Overall Response

* Efficacy of treatment will be assessed by the overall response rate (ORR; ORR = CR + VGPR + PR) and clinical benefit rate (CBR; CBR = CR + VGPR + PR + MR) of the doublet and triplet combinations * PFS1 as defined based on the length of time that patient was receiving therapy consisting of ruxolitinib with steroids until PD or death from any cause as determined by either an increase in sBCMA of ≥25% from its nadir or using IMWG criteria * PFS2 as defined based on the length of time that patient was receiving ruxolitinib, lenalidomide and steroid therapy to the time they reached disease progression as determined by the standard IMWG criteria or death from any cause * PFS from start of study treatment to disease progression as determined by the standard IMWG criteria or death from any cause including receiving treatment with ruxolitinib, lenalidomide and steroid

Time frame
54 months

Other outcomes

Sponsors and contacts

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

Oncotherapeutics

Lead sponsor

Incyte Corporation

Collaborator

Source ClinicalTrials.gov
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