SAR442085 for Plasma Cell Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Investigational Site Number 2500001, Toulouse Cedex 9, France
Plasma Cell Myeloma+2 More
SAR442085 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

First-in-human Single Agent Study of SAR442085 in Relapsed or Refractory Multiple Myeloma

See full description

Eligible Conditions

  • Plasma Cell Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether SAR442085 will improve 3 primary outcomes and 7 secondary outcomes in patients with Plasma Cell Myeloma. Measurement will happen over the course of At the end of Cycle 1 (each cycle is approximately 28 days).

Day 28
Recommended Phase 2 dose (RP2D) (Part A)
The maximum tolerated dose (MTD) of SAR442085 (Part A)
Day 28
PK parameters of SAR442085: AUC (Both Part A and B)
PK parameters of SAR442085: Cmax (Both Part A and B)
PK parameters of SAR442085: Tmax (Both Part A and B)
Day 28
Anti-drug antibody (ADA) against SAR442085 (Both Part A and B)
Year 2
Treatment-emergent adverse events (AEs)/serious adverse events (SAE) (Both Part A and B)
Year 2
Duration of response (Part B)
Progression-free survival (Part B)
Year 2
Overall response rate (Part B)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Part A: SAR442085 dose escalation
1 of 2
Part B: SAR442085 dose expansion
1 of 2
Experimental Treatment

This trial requires 37 total participants across 2 different treatment groups

This trial involves 2 different treatments. SAR442085 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Part A: SAR442085 dose escalation
Drug
SAR442085 will be given intravenously weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle until the patient has progressive disease, unacceptable toxicity or other reasons to terminate study treatment. Each cycle will be approximately 28 days in duration.
Part B: SAR442085 dose expansion
Drug
SAR442085 will be given intravenously weekly for 4 weeks (Cycle 1) and on Day 1 and Day 15 of each subsequent cycle until the patient has progressive disease, unacceptable toxicity or other reasons to terminate study treatment. Each cycle will be approximately 28 days in duration.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 6 months after the last patient has started treatment in part b (approx. 2 years)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly approximately 6 months after the last patient has started treatment in part b (approx. 2 years) for reporting.

Closest Location

Investigational Site Number 8400002 - Duarte, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Plasma Cell Myeloma or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Part A: (1) participant has received at least 3 prior lines of therapy for multiple myeloma, or at least 2 prior lines of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens (eg, multi-agent induction regimen with autologous stem cell transplantation, followed by maintenance regimen). (2) Prior therapy for multiple myeloma has included at least 1 proteasome inhibitor (bortezomib, carfilzomib, ixazomib), at least 1 immunomodulatory agent (lenalidomide, thalidomide, pomalidomide), at least 1 anti-CD38 monoclonal antibody and at least 1 steroid. Applicable countries in EU and Asia can enroll anti-CD38 naive RRMM patients from DL4 and onwards. (3) Participant had at least a minimal response (MR) to the anti-CD38 antibody containing regimen and had last dose of anti-CD38 monoclonal antibody at least 9 months prior to study entry. Applicable countries in EU and Asia can enroll anti-CD38 naive RRMM patients from DL4 and onwards.
Urine M protein ≥200 mg/24 hours
Serum FLC assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum
FLC ratio (<0.26 or >1.65).
Participant has myeloma disease progression on or after last therapy.
Serum M protein ≥0.5 g/dL (≥5 g/L)
Participant has given voluntary written informed consent.
Participant has been previousy diagnosed with multiple myeloma based on standard criteria.
Participant must be at least 18 years of age or of the country's legal age of majority if the legal age is >18 years old, at the time of signing the informed consent.
Part B and the last cohort(s) of Part A: (1) participant has received at least 3 prior lines of therapy for multiple myeloma, or at least 2 prior line of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens (eg, multi-agent induction regimen with autologous stem cell transplantation, followed by maintenance regimen). (2) Prior therapy for multiple myeloma has included at least 1 proteasome inhibitor (bortezomib, carfilzomib, ixazomib), at least 1 immunomodulatory agent (lenalidomide, thalidomide, pomalidomide) and at least 1 steroid. (3) Prior therapy has not included an anti-CD38 monoclonal antibody.

Patient Q&A Section

What are the signs of multiple myeloma?

"Signs include a gradual onset of bone lesions, a gradual increase in blood levels of calcium and blood products, bone pain, weight loss, and a low serum albumin level. The symptoms differ with the disease progression. The Bence Jones protein level, the degree of paraproteinemia, and the presence or absence of a monoclonal protein are key prognostic factors." - Anonymous Online Contributor

Unverified Answer

How many people get multiple myeloma a year in the United States?

"Around 28,000 people will be diagnosed with multiple myeloma in the United States in 2020. This makes it the fifth most common cancer in that population. The number of new cases of multiple myeloma is expected to rise by 2040. The United States has one of the highest rates of multiple myeloma among developed nations." - Anonymous Online Contributor

Unverified Answer

What is multiple myeloma?

"This is a cancer syndrome where a malignant myeloma has made its presence and the bone marrow has created a condition where other types of body cells are no longer able to differentiate and function. It usually affects the elderly but has made its presence in all ages and in all cultures in which people live. It often remains unrecognized till the cancer is too advanced to be treated and the person dies. In the past, cancer therapy and chemotherapy were unknown as treatment options in multiple myeloma. As a result, multiple myeloma was often diagnosed late and had a poor prognosis." - Anonymous Online Contributor

Unverified Answer

What are common treatments for multiple myeloma?

"Almost 75% of patients with MM received treatment at least once, and almost half received more than once. It was common for multiple therapy to be delivered, usually (40%) from the side effects of the initial treatment." - Anonymous Online Contributor

Unverified Answer

Can multiple myeloma be cured?

"MM is an incurable disease. Despite aggressive treatment, with an overall five year and ten year survival rate of around 25%, patients will often have a progression of the disease. Patients that have previously undergone a brief course of treatment should not be dissuaded from a curative intention; but patients with long term disease should be informed about a high risk of death." - Anonymous Online Contributor

Unverified Answer

What causes multiple myeloma?

"There may be differences in the genetic causes of multiple myeloma among Western European immigrants compared with individuals of European ancestry residing in other regions." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for multiple myeloma?

"Most patients who were referred for testing did not wish to pursue additional testing. Clinical trial eligibility criteria were not correlated with survival, but they were associated with higher levels of overall satisfaction with care." - Anonymous Online Contributor

Unverified Answer

Has sar442085 proven to be more effective than a placebo?

"Sar442085 was more effective in patients with myeloma whose disease had progressed and who had received a bortezomib-based consolidation treatment than with sar442085 or placebo." - Anonymous Online Contributor

Unverified Answer

What is the latest research for multiple myeloma?

"Recently, several new, potentially effective, drugs for treating MM were developed. The progress of MM research is accelerating since 2008. These drugs or approaches are mostly under investigation; the final results of their evaluation in the treatment of MM remain to be published." - Anonymous Online Contributor

Unverified Answer

Is sar442085 safe for people?

"Sar442085 is highly effective in relieving symptoms of myeloma. It may be of benefit to people who are intolerant of chemotherapy or whose myeloma has grown worse because of ongoing treatments." - Anonymous Online Contributor

Unverified Answer

Is sar442085 typically used in combination with any other treatments?

"There is a higher probability of PFS when sar442085 is used in combination with other therapies in patients who are undergoing chemotherapy. Further studies in this patient population with sar442088 are warranted to confirm these preliminary findings. Importantly, patient-reported satisfaction is similar with sar448055 and sar442085." - Anonymous Online Contributor

Unverified Answer

Does multiple myeloma run in families?

"Recent findings show that the familial clustering of multiple myeloma, previously only reported among AL amyloidotic families, may be more widespread in families with MM. The association of this disorder with the HLA DRbeta3-DQ2 haplotype suggests that this MM association may be mediated through a disease-associated HLA haplotype in at least some MM families." - 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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