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

Part of paid clinical trials in West Hollywood, California.

Sponsor
Oncotherapeutics
Study ID
NCT06209606
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Dec 8, 2022
Status verified
Dec 2024
Primary completion
May 31, 2026
Completion
Feb 28, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Rux + Steroid
    Subject will receive Ruxolitinib Oral Tablet \[Jakafi\] at 15mg BID, and Methylprednisolone at 40mg QOD until disease progression. Lenalidomide at 10mg QD will be added to the treatment (Ruxolitinib, Methylprednisolone) once disease progression was confirmed.
  • Experimental: Rux + Steroid + Len
    Ruxolitinib Oral Tablet \[Jakafi\] at 5mg, 10mg or 15mg BID, Lenalidomide Oral at 5mg or 10mg QD and Methylprednisolone Oral at 40mg QOD. (Dose varies during dose escalation portion of the study)

Primary Outcome Measure

Time to Disease Progression (TTP) [ Time Frame: 54 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Berenson Cancer CenterWest HollywoodCalifornia90069
Regina Swift, RN
[email protected]
310-623-1222
Marceya Soto
[email protected]
310-623-1222
James Berenson, MD

Find similar trials in West Hollywood, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Berenson Cancer Center· West Hollywood, CA

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