Study of the Efficacy and Safety of RsqVD Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02219178
• Date of registration: 11/08/2014
• Prospective Registration: Yes
• Primary sponsor: Cancer Trials Ireland
• Public title: Study of the Efficacy and Safety of RsqVD Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma
• Scientific title: A Phase II Study of the Efficacy and Safety of Lenalidomide, Subcutaneous Bortezomib, and Dexamethasone Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma
• Date of first enrolment: November 2014
• Target sample size: 42
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02219178
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Ireland

Contacts

• Name: Peter O'Gorman, Dr
• Affiliation: Mater Misericordiae University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Participants must have a diagnosis of symptomatic MM, according to International
Myeloma Foundation 2003 Diagnostic Criteria:

- Clonal plasma cells > 10% on bone marrow biopsy

- A monoclonal protein (paraprotein) in either serum or urine ( except in the cases
of non-secretory myeloma).

If no monoclonal protein is detected (non-secretory disease), then = 30% monoclonal
bone marrow plasma cells and/or a biopsy-proven plasmacytoma required.

- Evidence of end-organ damage felt related to the plasma cell disorder related
organ or tissue impairment (ROTI), commonly referred to by the acronym 'CRAB':

- Hypercalcaemia: serum calcium (corrected for albumin) >
10.5mg/sL/>2.65mmol/L or upper limit of normal

- Renal insufficiency defined as serum creatinine > 2mg/sL/177µmol/L

- Anaemia: Normochromic, normocytic with a haemoglobin value > 2g/dL below the
lower limit of normal or a haemoglobin < 10g/dL

- Bone lesions (lytic lesions, severe osteopenia or pathologic fractures) as
shown by CT scan and/or skeletal survey

2. Patient has received no prior treatment with any systemic therapy for the treatment of
multiple myeloma.

- Prior treatment of hypercalcaemia or spinal cord compression with corticosteroids
does not disqualify the patient (the dose should not exceed the equivalent of 160
mg of dexamethasone in a 2 week period)

- Bisphosphonates are permitted

- Patients treated with local radiotherapy with or without concomitant exposure to
steroids, for pain control or management of cord/nerve root compression, are
eligible. Two weeks must have lapsed since last date of radiotherapy, which is
recommended to be a limited field. Patients who require concurrent radiotherapy
should have entry to the protocol deferred until the radiotherapy is completed
and 2 weeks have passed since the last date of therapy.

3. Voluntary written informed consent before performance of any study-related procedure
not part of normal medical care, with the understanding that consent may be withdrawn
by the subject at any time without prejudice to future medical care

4. Age = 18 years at the time of signing Informed Consent

5. Females of reproductive potential must adhere to the scheduled pregnancy testing as
required in the Lenalidomide Pregnancy Prevention Risk Management Plan. Females of
childbearing potential (FCBP) must have a negative serum or urine pregnancy test with
a sensitivity of at least 50 mlU/mL 10 to14 days prior to therapy and repeated again
within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be
filled within 7 days as required by Lenalidomide Pregnancy Prevention Risk Management
Plan) and must either commit to complete abstinence from heterosexual contact or begin
TWO acceptable methods of birth control, one highly effective method and one
additional effective (barrier) method, AT THE SAME TIME, at least 28 days before she
starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men
must practice complete abstinence or agree to use a condom during sexual contact with
a FCBP even if they have had a successful vasectomy. All study participants must be
registered into the mandatory Lenalidomide Pregnancy Prevention Risk Management Plan,
and be willing and able to comply with the requirements of the Lenalidomide Pregnancy
Prevention Risk Management Plan.*A female of childbearing potential is a sexually
mature female who: 1) has not undergone a hysterectomy (the surgical removal of the
uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not
been naturally postmenopausal (amenorrhea following cancer therapy does not rule out
childbearing potential) for at least 24 consecutive months (i.e. has had menses at any
time during the preceding 24 consecutive months)

6. All necessary baseline studies for determining eligibility must be obtained within 21
days prior to enrolment

7. Subject has an ECOG performance status of < 2 or Karnofsky performance status of = 60
(Appendix E).

8. Subject must be able to adhere to the study visit schedule and other protocol
requirements.

Exclusion Criteria:

1. Patient has = Grade 2 peripheral neuropathy on clinical examination within 14 days
before enrolment

2. Renal insufficiency (serum creatinine levels > 2.5 mg/dL/221µmol/L, calculated
creatinine clearance with Cockcroft-Gault formula (see Appendix G) < 45 ml/min)

3. Subjects with evidence of mucosal or internal bleeding and/or platelet refractory
(i.e. unable to maintain a platelet count 50,000 cells/mm3)

4. Subjects with an absolute neutrophil count (ANC) < 1000 cells/mm3. Growth factors may
not be used to meet ANC eligibility criteria

5. Subjects with a haemoglobin < 8.0 g/dL

6. AST (SGOT) and ALT (SGPT) > 2 x ULN, bilirubin levels 1.5 ULN

7. Concomitant therapy medications that include corticosteroids (except as indicated in
inclusion criteria)

8. Myocardial infarction within 6 months prior to enrolment or has New York Heart
Association (NYHA) Class III or IV heart failure (Appendix G), uncontrolled angina,
severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
ischemia or active conduction system abnormalities

9. Clinically relevant active infection requiring treatment (antibiotics, antivirals,
antifungals)

10. Any serious co-morbid condition, including laboratory abnormalities, that in the
opinion of the Investigator places the subject at unacceptable risk if he/she were to
participate in the study.

11. Female subject is pregnant or breast-feeding

12. Serious psychiatric illness or addiction likely to interfere with participation in
this clinical study

13. Uncontrolled diabetes mellitus

14. Contraindication to any required concomitant drugs or supportive therapies including
hypersensitivity to all anticoagulation and antiplatelet options or hypersensitivity
to acyclovir or similar anti-viral drug. History of allergic reaction/hypersensitivity
attributed to compounds containing boron, mannitol, polysorbate 80 or sodium citrate
dehydrate

15. POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly,
endocrinopathy, monoclonal protein (M-protein) and skin changes)

16. Known seropositiv


Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Myeloma

Intervention(s)

Drug: lenalidomide

Drug: Dexamethasone

Drug: Subcutaneous bortezomib

Primary Outcome(s)

To evaluate the overall response rate (ORR) after 4 induction cycles [Time Frame: After 4 cycles (84 days)]

Secondary Outcome(s)

Progression of disease [Time Frame: Duration of the study, expected to be approximately 3 years]

Duration of response [Time Frame: Duration of the study, expected to be approximately 3 years]

a) To evaluate the rate and severity of Peripheral Neuropathy (PN) of SQ bortezomib in combination with lenalidomide, and dexamethasone after the 4th and after the final cycle of induction therapy. [Time Frame: After 4 cycles (84 days)]

Progression free survival [Time Frame: Duration of the study, expected to be approximately 3 years]

Secondary ID(s)

2013-005008-32

CTRIAL-IE (ICORG) 13-17

Source(s) of Monetary Support

Please refer to primary and secondary sponsors