Multi-center, Open-label, Phase 1b Study in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

Overview

Total study duration is variable depending on treatment and follow-up periods, including 21 days of screening, and treatment period until disease progression, unacceptable adverse reaction or other reason for discontinuation. End of treatment will be 30 days after last administration of investigational medicinal product, or approximately 14 months after first study treatment administration.

SparkCures ID 1018
Trial Phase Phase 1
Enrollment 46 Patients
Treatments
Trial Sponsors
  • Sanofi
NCT Identifier

NCT04045795

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion criteria:

  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
  • Participant must be above 18 years of age inclusive, at the time of signing the informed consent.
  • Participant has been previously diagnosed with multiple myeloma (MM) based on standard criteria and currently requires treatment because MM has relapsed following a response, according to International Myeloma Working Group (IMWG) criteria.
  • Participant has received at least two previous therapies including lenalidomide and a proteasome inhibitor and has demonstrated disease progression on last therapy or after completion of the last therapy.
  • Participants with measurable disease defined as at least one of the following:
  • Serum M protein ≥ 0.5 g/dL (≥5 g/L).
  • Urine M protein ≥ 200 mg/24 hours.
  • Serum free light chain (FLC) assay: Involved FLC assay ≥ 10 mg/dL (≥ 100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).
  • Male or female: Contraceptive use by men or women.

Exclusion criteria:

  • Malignancy within 3 years prior to enrollment.
  • Eastern Cooperative Oncology Group (ECOG) performance status score >2.
  • Inadequate hematological, liver or renal function.
  • Serum calcium (corrected for albumin) level above the upper limit of normal (ULN) range.
  • Primary refractory or intolerant to prior therapy with any anti-CD38 mAb or had disease progression during anti-CD38 mAb, administered as last therapy.
  • Participant did not achieve a minimal response or better to at least one of the previous lines of treatment (ie, primary refractory disease is not eligible).
  • Received any investigational drug within 14 days or 5 half-lives of the investigational drug, whichever is longer.
  • Prior anti-cancer therapy within 14 days.
  • Any >Grade 1 adverse reaction unresolved from previous treatments according to the NCI-CTCAE v5.0. The presence of alopecia or peripheral neuropathy ≤ Grade 2 without pain is allowed.
  • Previous allogeneic stem cell transplantation with active Graft Versus Host Disease or being under immunosuppressive therapy in the last 2 months previously to the inclusion in the trial.
  • Daily requirement for corticosteroids.
  • Known to be HIV+ or to have hepatitis A, B or C active infection.
  • Active tuberculosis and severe infections requiring treatment with antibiotic parenteral administration.
  • Any clinically significant, uncontrolled medical conditions that, in the Investigator's opinion, would expose excessive risk to the patient or may interfere with compliance or interpretation of the study results.
  • History of erythema multiforme or severe hypersensitivity to prior immunomodulatory drugs (IMiDs).
  • Hypersensitivity or history of intolerance to immunomodulatory drugs (IMiDs), dexamethasone, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study therapy that are not amenable to premedication with steroids and histamine H2 blockers or would prohibit further treatment with these agents.
  • Inability to tolerate thromboprophylaxis.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

California

Resources

There are no resources, links or videos to display for this clinical trial.